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The objective of this review is to give an overview of the demographic, peri-, and postoperative factors that have been assessed for influence on self-perceived functioning at least 3 months after volar locking plate fixation of a distal radius fracture.Most patients treated with a volar locking plate for a distal radius fracture recover within months after surgery; however, a subgroup of patients experience complications and slow recovery. A variety of demographic, peri-, and postoperative factors may influence self-perceived functioning. To facilitate functioning after surgery, supervised rehabilitation can be offered by a hand therapist. In the decision-making process about which patients to offer supervised rehabilitation, demographic, peri-, and postoperative factors may provide additional information, but no updated overview of explored factors has been found.This review will consider all studies reporting on peri- and postoperative factors identified within 6 weeks after surgery, or demographic factors assessed for influence on self-perceived functioning experienced by patients at least 3 months after volar locking plate fixation of distal radius fractures.MEDLINE, CINAHL, Embase, Cochrane Library, PsycINFO, SPORTSdiscus, and Web of Science will be searched for eligible studies. The review will consider peer-reviewed studies published after 2005 in English and Scandinavian languages. Two reviewers will independently perform study selection and data extraction. Following a content analysis of each identified factor, the factors will be mapped to the International Classification of Functioning, Disability and Health (ICF) components by using the ICF linking rules. An overview will be depicted graphically or in tabular format for different timepoints based on assessment of the self-perceived functioning.

PurposePhysical activity is recommended to cancer survivors by the World Health Organisation (WHO) and is associated with improved survival after colorectal cancer. It remains unclear whether having a stoma is a barrier for an active lifestyle. We examined the level of physical activity and explored factors impacting physical activity in survivors with a stoma.MethodsA total of 1265 (65%) patients in the Danish Stoma Database completed a multidimensional survey. Physical activity of moderate- and vigorous-intensity was assessed using two validated questions. Based on WHO guidelines, physical activity was categorised into ‘Meeting’ or ‘Not Meeting’ recommendations. Multivariate regression analysis, adjusting for potential confounders, provided odds ratio (OR) and 95% confidence intervals (CI) for factors’ association with’Not Meeting’ guideline recommendations.ResultsIn total, 571 patients with colorectal cancer reported on physical activity at a median of 4.3 years (interquartile range 3.1–5.8) after stoma surgery. Two hundred ninety-three patients (51%) were ‘Meeting recommendations’ and 63% of them were ‘Highly active’. Two hundred seventy-eight were ‘Not meeting’ recommendations (49%).Of the factors analysed, patients without support garment were more likely (OR 1.72 [95% CI 1.16; 2.54] not to meet guideline recommendations. We found no association between stoma type, surgical procedure, parastomal bulging and ‘problematic stoma’ and level of physical activity, respectively.ConclusionIn this large sample of survivors with a stoma half of patients met or exceeded guideline recommendations. Of patients not meeting recommendations some could potentially meet the recommendations by modest increases in either moderate or vigorous activity.

Background Sparse evidence exists regarding the feasibility and patients' experiences of exercise programs among older cancer populations. Objective The aim of this study was to explore the experiences of older patients with advanced cancer who participated in a 12-week supervised and multimodal exercise program in a hospital setting. Methods Individual interviews were conducted with 18 participants (≥65 years) with advanced cancer who completed the intervention program regardless of compliance rate. In addition, written evaluation questionnaires were collected. Data were analyzed using thematic analysis. Results Three main themes were identified: (1) Motivated to strengthen body and mind, with the subthemes "Doing what only I can do"and "Reaching goals with support from healthcare professionals and peers"; (2) Exercise as an integrated part of the treatment course; and (3) Overcoming undeniable physical limitations. Conclusions The participants experienced several benefits from participation, including physical improvements, increased energy, reduction of symptoms, and improved social engagement. Goal setting, being positively pushed and cheered on, and integration of fun games increased motivation. In contrast, being pushed beyond physical limitations and experiencing severe symptoms were experienced as barriers toward exercising. Adherence to the exercise program was facilitated by coordinating a tailored program with medical appointments and receiving comprehensive support and guidance. Implications for Practice Multimodal exercise programs seem to be beneficial for older patients with advanced cancer and should be coordinated with oncological treatment in combination with targeted support and advice on symptom management.

Background: Postoperative mobilisation after fast-track colorectal surgery is challenging for patients, and knowledge of patients' needs during this phase is important to improve surgical care. Aim: This study aimed to explore patients' views on, experiences of and recommendations for early mobilisation after colorectal surgery. Methods: This qualitative study used semi-structured individual interviews with patients in days 1–5 after colorectal surgery, and the data underwent content analysis. Findings: The 11 participants experienced dizziness and exhaustion impeding early mobilisation, and participants emphasised the importance of nurses for motivating mobilisation, as well as that they found the lack of space for exercising to be distressing. Companionship with other patients induced participants to get out of bed and help other patients mobilise. Finally, participants recounted their experiences of the usefulness of walking aids and of which activities were possible during hospitalisation. Conclusions: Nurses were key motivators for early mobilisation and need to be aware of this. Patients requested relevant exercises and space for exercising to facilitate postoperative recovery.

PurposeTo synthesise evidence on low back pain (LBP) in adult rowers and to create a consensus statement to inform clinical practice.MethodsThere were four synthesis steps that informed the consensus statement. In step one, seven expert clinicians and researchers established the scope of the consensus statement and conducted a survey of experienced and expert clinicians to explore current practice. In step two, working groups examined current evidence relating to key scope questions and summarised key issues. In step three, we synthesised evidence for each group and used a modified Delphi process to aid in the creation of the overall consensus statements. Finally, in step four, we combined information from step three with the findings of the clinician survey (and with athlete and coach input) to produce recommendations for clinical practice.ResultsThe scope of the consensus statement included epidemiology; biomechanics; management; the athlete’s voice and clinical expertise. Prevention and management of LBP in rowers should include education on risk factors, rowing biomechanics and training load. If treatment is needed, non-invasive management, including early unloading from aggravating activities, effective pain control and exercise therapy should be considered. Fitness should be maintained with load management and progression to full training and competition. The role of surgery is unclear. Management should be athlete focused and a culture of openness within the team encouraged.ConclusionRecommendations are based on current evidence and consensus and aligned with international LBP guidelines in non-athletic populations, but with advice aimed specifically at rowers. We recommend that research in relation to all aspects of prevention and management of LBP in rowers be intensified.

ObjectivesRowing-related low back pain (LBP) is common but published management research is lacking. This study aims to establish assessment and management behaviours and beliefs of experienced and expert clinicians when elite and subelite rowers present with an acute episode of LBP; second, to investigate how management differs for developing and masters rowers. This original research is intended to be used to develop rowing-related LBP management guidelines.MethodsA three-round Delphi survey was used. Experienced clinicians participated in an internet-based survey (round 1), answering open-ended questions about assessment and management of rowing-related LBP. Statements were generated from the survey for expert clinicians to rate (round 2) and rerate (round 3). Consensus was gained when agreement reached a mean of 7 out of 10 and disagreement was 2 SD or less.ResultsThirty-one experienced clinicians participated in round 1. Thirteen of 20 invited expert clinicians responded to round 2 (response rate 65%) and 12 of the 13 participated in round 3 (response rate 92%).One hundred and fifty-three of 215 statements (71%) relating to the management of LBP in elite and subelite rowers acquired consensus status. Four of six statements (67%) concerning developing rowers and two of four (50%) concerning masters rowers gained consensus.ConclusionIn the absence of established evidence, these consensus-derived statements are imperative to inform the development of guidelines for the assessment and management of rowing-related LBP. Findings broadly reflect adult LBP guidelines with specific differences. Future research is needed to strengthen specific recommendations and develop best practice guidelines in this athletic population.

To investigate the absolute and relative reliability of the “graded cycling test with talk test” (GCT-TT) and the “30-second chair-stand test” (30s-CST) in men with prostate cancer receiving androgen deprivation therapy (ADT). Men with prostate cancer on ADT were included in this test-retest study. GCT-TT and 30s-CST were performed twice with 1 hour between test sessions. All tests were conducted by two experienced physiotherapists and all patients were familiar with the tests. Only intra-tester reliability was investigated as the test and retest of each participant were performed by the same physiotherapist. Intraclass correlation coefficient (ICC2.1), standard error of measurement (SEM and SEM95), and smallest real difference (SRD) were calculated. Sixty men were included with a mean age of 70.8 ± 6.6 (mean ± SD) years. All performed 30s-CST twice without any problems. Two participants were excluded from the analysis of the GCT-TT results. Relative reliability for 30s-CST (ICC2.1) was 0.97 [95% CI: 0.94–0.98] with low measurement error: SEM95, 1.9 repetitions, and SRD, 2.6 repetitions. The corresponding results for GCT-TT were ICC2.1, 0.90 [95% CI: 0.84–0.94]; SEM95, 19.9 W; and SRD, 28.2 W. The reliability of 30s-CST and GCT-TT is substantial for men with prostate cancer receiving ADT. Overall, an average 30s-CST improvement of 1.9 repetitions on a group level and three repetitions for individual patients are considered real improvements. A GCT-TT improvement exceeding 19.9 W represents a real improvement for a group of patients. Individual patients need to improve two steps (30 W).

ObjectivesWe aimed to determine the prevalence of low back pain (LBP) in sport, and what risk factors were associated with LBP in athletes.DesignSystematic review with meta-analysis.Data sourcesLiterature searches from database inception to June 2019 in Medline, Embase, Cumulated Index to Nursing and Allied Health Literature (CINAHL), Web of Science and Scopus, supplemented by grey literature searching.Eligibility criteriaStudies evaluating prevalence of LBP in adult athletes across all sports.ResultsEighty-six studies were included (30 732, range 20–5958, participants), of which 45 were of ‘high’ quality. Definitions of LBP varied widely, and in 17 studies, no definition was provided. High-quality studies were pooled and the mean point prevalence across six studies was 42%; range 18%–80% (95% CI 27% to 58%, I2=97%). Lifetime prevalence across 13 studies was 63%; range 36%–88% (95% CI 51% to 74%, I2=99%). Twelve-month LBP prevalence from 22 studies was 51%; range 12%–94% (95% CI 41% to 61%, I2=98%). Comparison across sports was limited by participant numbers, study quality and methodologies, and varying LBP definitions. Risk factors for LBP included history of a previous episode with a pooled OR of 3.5; range 1.6–4.0 (95% CI 1.9 to 6.4). Statistically significant associations were reported for high training volume, periods of load increase and years of exposure to the sport.ConclusionLBP in sport is common but estimates vary. Current evidence is insufficient to identify which sports are at highest risk. A previous episode of LBP, high training volume, periods of load increase and years of exposure are common risk factors.

To evaluate the feasibility of exercises for the abdominal muscles in patients after colostomy or ileostomy formation on the following parameters: muscle activity, pain, discomfort, and difficulty of performing the exercises.Patients with a new stoma were divided into groups based on time after surgery: Early group, 0-2 weeks (For the Early group, muscle activity reaching a predetermined threshold was measured for half of the participants in a few exercises. In both the Intermediate group and the Late group, muscle activity reaching the onset criteria was measured for all muscles for a high percentage of participants in several exercises. Both strengthening and coordinating exercises were feasible based on low ratings of pain, discomfort, and difficulty.This study identified feasible exercises that activated the abdominal muscles at different time points after stoma formation. The observations can be used as guidance for the choice of exercises in clinical practice and future research.Implications for rehabilitationThe findings of this study can be used in clinical practice as guidance for choice of exercise at different time points after surgery.This study identified useful exercises for activating the abdominal muscles in rehabilitation after stoma surgery from two weeks on.In the first two postoperative weeks, there was limited involvement of the abdominal muscles with the evaluated exercises.Most of the evaluated abdominal exercises were feasible after stoma surgery based on pain, discomfort, and difficulty.

BACKGROUND AND OBJECTIVES Measuring body composition is relevant in geriatric medical patients at high risk of sarcopenia (loss of muscle mass/strength) for diagnosis and monitoring efficacy of treatment interventions. Dual-energy X-ray absorptiometry (DXA) and bio-impedance analysis (BIA) are widely used in research/clinical practices, but their agreement is unknown in this population. Therefore, it was investigated how a dual-frequency (DF)-BIA compares to DXA regarding replicability, direct comparisons and monitoring of total/segmental body composition in geriatric medical patients. METHODS Measurements were taken while admitted to the geriatric medical ward and repeated 12 weeks after discharge for monitoring. Total population and gender-specific analyses were made. RESULTS Thirty-one participants were included (age: 82 ± 6 years, BMI: 26.2 ± 4.3), and ten lost to follow-up. Replicability was high for both methods (R2 ; 0.956, 0.999, p

Objectives: Physical inactivity is a major risk factor for stroke. It is a challenge for patients to initiate and adhere to regular exercise post-stroke. Early initiation of home-based high-intensity interval training (HIIT) may engage patients in physical activity, improve cardiorespiratory fitness, and reduce risk of recurrent stroke. Materials and Methods: Post-intervention follow-up of patients with lacunar stroke, randomized to three-months HIIT including weekly motivational calls, or usual care. At follow-up (six- and 12-months post-stroke), we investigated changes in cardiorespiratory fitness, physical activity, fatigue, depression, mental well-being, stress, cognition, cardiovascular function, and recurrent stroke. Results: We included 71 patients of whom 59 patients (mean age: 63.9 ± 8.8 years) completed six- and 12-month follow-up. No change was detected in cardiorespiratory fitness between groups from baseline to 12-months follow-up. At six months, vigorous-intensity activity (median hours/week [interquartile range]) was maintained in the intervention group (baseline, 0[0;2]; post-intervention, 2[0;3]; six-month, 2[0;4]) and increased in the usual care group (baseline, 0[0;1]; post-intervention, 1[0;2]; six-month, 1[0;3]), with no difference between groups. Vigorous-intensity activity declined to baseline levels at 12-months in both groups. Secondary outcomes improved from baseline to 12-months with no significant differences between groups. Similar rate of recurrent stroke (n=3) occurred in each group with a three-month delay in the intervention group. Conclusions: Early initiated HIIT did not increase long-term cardiorespiratory fitness, but increased time spent doing vigorous-intensity activities post-stroke. Decline to baseline activity level at 12 months warrants identification of motivators to initiate and sustain physical activity post-stroke.

Background: Older patients with cancer are at risk of physical decline and impaired quality of life during oncological treatment. Exercise training has the potential to reduce these challenges. The study aim was to investigate the feasibility and effect of a multimodal exercise intervention in older patients with advanced cancer (stages III/IV). Patients and Methods: Eighty-four older adults (≥65 years) with advanced pancreatic, biliary tract, or non-small cell lung cancer who received systemic oncological treatment were randomized 1:1 to an intervention group or a control group. The intervention was a 12-week multimodal exercise-based program including supervised exercise twice weekly followed by a protein supplement, a home-based walking program, and nurse-led support and counseling. The primary endpoint was change in physical function (30-second chair stand test) at 13 weeks. Results: Median age of the participants was 72 years (interquartile range [IQR] 68–75). Median adherence to the exercise sessions was 69% (IQR 21–88) and 75% (IQR 33–100) for the walking program. At 13 weeks, there was a significant difference in change scores of 2.4 repetitions in the chair stand test, favoring the intervention group (p

Aim To examine the incidence of primary and recurrent repair and types of repair performed in patients with parastomal bulging. Material and Methods We linked prospectively collected data on parastomal bulging from the Danish Stoma Database to surgical data on repair of parastomal bulging from the Danish National Patient Register. Survival statistics provided cumulative incidences and time until primary and recurrent repair Results Of 1016 patients, registered from 2010-2017 with a permanent stoma and a parastomal bulge, 180 (18%) underwent surgical repair. The cumulative incidence of a primary repair was 9% (95% CI [8%; 11%]) within 1 year and 19% (95% CI [17%; 22%]) within 5 years after the occurrence of a parastomal bulge. For colostomies and ileostomies, we found similar probability of undergoing primary repair. For recurrent repair, the 5-year cumulative incidence was 5% (95% CI [3%; 7%]). The probability of undergoing further recurrent repair was 33% (95% CI [21%; 46%]) within 5 years. For primary repair, open or laparoscopic repair with mesh (43%) and stoma revision (39%) were performed almost equally frequent. Stoma revision and repair with mesh could precede and follow one another as primary and recurrent repair. Stoma reversal was performed in 17% of patients. Conclusions Our data offered a new and comprehensive view of the course of surgical treatment of parastomal bulging. Five years after the occurrence of a parastomal bulge the estimated probability of undergoing a repair was 19%. The probability of undergoing recurrent repair was high and stoma reversal more common than expected.

The incidence of colorectal cancer (CRC) increases with age. In combination with an ageing population, the number of older patients undergoing surgical treatment for CRC is therefore expected to increase. Sarcopenia and cachexia are potentially modifiable risk factors of a negative surgical outcome. Sarcopenia can be categorized into primary (age-related) and secondary where diseases, such as malignancy, are influential factors. We aimed to investigate the prevalence of preoperative sarcopenia and cachexia in older (≥65 years) vulnerable patients with localized CRC.Patients included in the randomized study "Geriatric assessment and intervention in older vulnerable patients undergoing resection for colorectal cancer," were screened for sarcopenia and cachexia prior to surgery. All patients in the present cohort were considered vulnerable with Geriatric 8 ≤ 14 points. Sarcopenia was defined according to European Guidelines (EWGSOP2), based on low muscle strength-low handgrip-strength and/or slow 5xChair-Stand-Test-and low appendicular lean mass assessed by dual-energy X-ray absorptiometry. Cachexia was defined as self-reported unintended weight loss5% within three months or 2-5% with body mass index20 kg/mSixty-four patients (mean age 79.6 years ±6.4 years, 36 women) were assessed. Of these, 28% (n = 18, 11 women) had low muscle strength and 13% (n = 8, 4 women) fulfilled the criteria for sarcopenia, however, 33% (n = 21, 13 women) had low muscle mass. There was no correlation between low muscle strength and low muscle mass (r = 0.16, P = 0.22). The prevalence of cachexia was 36% (n = 23, 16 women). Low muscle mass was associated with cachexia (φ = 0.38, P = 0.005), but there was no association between sarcopenia and cachexia (φ = 0.01, P = 1.0).Despite the included patients who fulfilled the criteria for vulnerability according to G8, relatively few (28%) had low muscle strength. Moreover, there was poor overlap between the prevalence of sarcopenia according to the EWGSOP2 guidelines (13%) and prevalence of low muscle mass (33%) in older patients with CRC. Of note also, there was no association between sarcopenia and cachexia, but an association between cachexia and low muscle mass, which highlights the importance of assessing muscle mass in patients with cancer.The GEPOC trial has been prospectively registered at http://clinicaltrials.gov (NCT03719573).

PURPOSE: Older patients with cancer are underrepresented in exercise-based trials. To engage older patients in physical activity (PA), it is necessary to consider age-related decline in health, comorbidities and practicalities. The study aim was to explore attitudes towards PA and exercise among older patients with cancer to inform future exercise-based interventions.METHOD: Individual interviews (N = 23) were conducted in patients ≥ 65 years with advanced lung, biliary tract and pancreatic cancer receiving palliative oncological treatment. Patients were recruited with a purposive sampling strategy. A semi-structured interview guide focusing on attitudes towards PA and exercise, including barriers, facilitators and motivators, was used. Data on the informants' medical history, demographics and PA level was collected.RESULTS: Identified themes were: 1) a general positive perception of physical activity is expressed 2) comorbidities and external circumstances prevent physical activity, 3) fatigue overshadows life, 4) social support is key to short and long-term motivation, 5) fixed conditions keep one focused, 6) familiarity raises confidence and motivation.CONCLUSIONS: Even though perceptions of PA were positive among older patients with cancer, most struggled to stay physically active during oncological treatment. Several factors related to cancer and aging were identified as barriers; most profoundly was the overwhelming feeling of fatigue. Improving physical and mental well-being, fixed conditions (e.g. group-based exercise and supervision) and social support were identified as motivators and facilitators. Preferences for PA varied, but activities that were familiar increased motivation. Exercise programs for older patients with cancer must be adjustable to each patient's limitations, needs and personal resources.

Sarcopenia (loss of muscle mass/strength) burdens many older adults – hospitalised older adults being particularly vulnerable. Treating the condition, protein supplementation (PrS) and resistance training (RT) may act synergistically. Therefore, this block-randomised, double-blind, multicentre intervention study, recruiting geriatric patients > 70 years from three medical departments, investigated the effect of PrS combined with RT during hospitalisation and 12 weeks after discharge. Participants were randomly allocated (1:1) to receive PrS (totally 27·5 g whey protein/d, about 2000 kJ/d) or isoenergetic placebo-products (< 1·5 g protein/d) divided into two servings per d to supplement the habitual diet. Both groups were engaged in a standardised, progressive low-intensity RT programme for the lower extremities (hospital: supervised daily/after discharge: self-training 4×/week). From April 2016 to September 2017, 2351 patients were screened, 462 were eligible, and 165 included. Fourteen were excluded and ten dropped out, leaving 141 participants in the intention-to-treat analysis. The average total protein intake during hospitalisation/after discharge was 1·0 (interquartile range (IQR) 0·8, 1·3)/1·1 (IQR 0·9, 1·3) g/kg per d (protein-group) and 0·6 (IQR 0·5, 0·8)/0·9 (IQR 0·6, 1·0) g/kg per d (placebo group). Both groups improved significantly for the primary and secondary endpoints of muscle mass/strength, functional measurements and quality of life, but no additional effect of PrS was seen for the primary endpoint (30-s chair stand test, repetitions, median changes from baseline: (standard test: 0 (IQR 0, 5) (protein group) v. 2 (IQR 0, 6) (placebo group) and modified test: 2 (IQR 0, 5) (protein group) v. 2 (IQR −1, 5) (placebo group)) or any secondary endpoints (Mann–Whitney U tests, P > 0·05). In conclusion, PrS increasing the total protein intake by 0·4 and 0·2 g/kg per d during hospitalisation and after discharge, respectively, does not seem to increase the adaptive response to low-intensity RT in geriatric medical patients.

Effects of exercise in patients with breast cancer have been thoroughly investigated. The aim was to explore differences in effects regarding type, delivery mode and extensiveness (e.g. intensity; volume) of the interventions.We searched for randomised controlled trials including patients with breast cancer receiving systemic treatment, exercise-based interventions, and measures on patient reported- and objectively measured outcomes.Exercise showed significant and moderate effects on the primary outcomes quality of life and physical function, Standardised Mean Difference: 0.52 (95 % CI 0.38-0.65) and 0.52 (95 % CI 0.38-0.66), respectively. Type of exercise had little influence on the effects, however combined aerobic- and resistance exercise seemed superior for increasing physical function, compared to aerobic or resistance exercise. Supervised interventions were superior to partly and unsupervised. Extensiveness of the intervention only influenced physical function.Supervised interventions, more than type or extensiveness of interventions, seem to increase effects.

ObjectiveTo summarise the evidence for non-pharmacological management of low back pain (LBP) in athletes, a common problem in sport that can negatively impact performance and contribute to early retirement.Data sourcesFive databases (EMBASE, Medline, CINAHL, Web of Science, Scopus) were searched from inception to September 2020. The main outcomes of interest were pain, disability and return to sport (RTS).ResultsAmong 1629 references, 14 randomised controlled trials (RCTs) involving 541 athletes were included. The trials had biases across multiple domains including performance, attrition and reporting. Treatments included exercise, biomechanical modifications and manual therapy. There were no trials evaluating the efficacy of surgery or injections. Exercise was the most frequently investigated treatment; no RTS data were reported for any exercise intervention. There was a reduction in pain and disability reported after all treatments.ConclusionsWhile several treatments for LBP in athletes improved pain and function, it was unclear what the most effective treatments were, and for whom. Exercise approaches generally reduced pain and improved function in athletes with LBP, but the effect on RTS is unknown. No conclusions regarding the value of manual therapy (massage, spinal manipulation) or biomechanical modifications alone could be drawn because of insufficient evidence. High-quality RCTs are urgently needed to determine the effect of commonly used interventions in treating LBP in athletes.

Physical activity is recommended to cancer survivors by the World Health Organisation (WHO) and is associated with improved survival after colorectal cancer. It remains unclear whether having a stoma is a barrier for an active lifestyle. We examined the level of physical activity and explored factors impacting physical activity in survivors with a stoma.A total of 1265 (65%) patients in the Danish Stoma Database completed a multidimensional survey. Physical activity of moderate- and vigorous-intensity was assessed using two validated questions. Based on WHO guidelines, physical activity was categorised into 'Meeting' or 'Not Meeting' recommendations. Multivariate regression analysis, adjusting for potential confounders, provided odds ratio (OR) and 95% confidence intervals (CI) for factors' association with'Not Meeting' guideline recommendations.In total, 571 patients with colorectal cancer reported on physical activity at a median of 4.3 years (interquartile range 3.1-5.8) after stoma surgery. Two hundred ninety-three patients (51%) were 'Meeting recommendations' and 63% of them were 'Highly active'. Two hundred seventy-eight were 'Not meeting' recommendations (49%). Of the factors analysed, patients without support garment were more likely (OR 1.72 [95% CI 1.16; 2.54] not to meet guideline recommendations. We found no association between stoma type, surgical procedure, parastomal bulging and 'problematic stoma' and level of physical activity, respectively.In this large sample of survivors with a stoma half of patients met or exceeded guideline recommendations. Of patients not meeting recommendations some could potentially meet the recommendations by modest increases in either moderate or vigorous activity.

Post-approval changes (PACs) are inevitable and necessary throughout the life of a drug product. Because many PACs require prior approval by individual regulatory agencies each having their own reporting requirements and approval timelines, this results in companies having to manage several versions of a manufacturing process at the same time. The global regulatory complexity increases risk of drug shortages. Chief quality officers and heads of quality from more than 20 global pharmaceutical companies have come together to speak with One-Voice-of-Quality (1VQ) and develop solutions to this problem by developing a science and risk-based approach to manage more PACs in the pharmaceutical quality system (PQS) rather than submitting these as prior approval supplements. Pharmaceutical companies already conduct management review (MR) according to the International Conference on Harmonization (ICH) Q10. This One-Voice-Of-Quality paper is a practical guide on how companies can expand the MR to also evaluate and demonstrate the effectiveness of their PQS in specifically managing PACs to achieve regulatory flexibility as stated in ICH Q10, Annex 1. Examples of PQS key performance indicators (KPIs) that may be used to assess, plan, implement, and monitor PACs are described. The intent is to provide assurance through MR that PACs can be managed effectively in the PQS, thereby resulting in a reduced need for regulatory prior approval of certain low risk changes that enhance product availability, reduce the risk of drug shortages, and/or facilitate timely innovation and continual improvement in the pharmaceutical industry. This document is endorsed by 1VQ chief quality officers and heads of quality.

Validation of the Danish version of the SARC-F (Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls) for hospitalized geriatric medical patients, compared against the original EWGSOP (European Working Group on Sarcopenia in Older People) and revised EWGSOP2 definition for sarcopenia. Additionally, investigation of the ability of SARC-F to individually identify low strength/function and muscle mass. Cross-sectional analysis of data from an RCT. Hospital, Medical Department. 122 geriatric medical patients (65.6% women) ≥ 70 years of age with mixed medical conditions. SARC-F screening, diagnostic assessment of sarcopenia (hand-grip strength, muscle mass measured by dual-frequency bio-impedance analysis, and 4-m usual gait speed). The prevalence of risk of sarcopenia (SARC-F ≥ 4) was 48.3%, while it was diagnosed in 65.8% and 21.7%, with EWGSOP and EWGSOP2, respectively. The sensitivity, specificity, positive predictive value, negative predictive value according to EWGSOP were 50.0 %, 53.7 %, 67.2% and 36.1%, while they were 53.8 %, 53.2 %, 24.1% and 80.6%, according to EWGSOP2 (all participants). The ability of SARC-F to predict reduced strength, function, and muscle mass was modest. There was a significant negative linear, yet weak, relationship between total SARC-F score and hand-grip strength (R2=0.033) and 4-m gait speed (R2=0.111), but not muscle mass (R2=0.004). SARC-F does not seem to be a suitable screening tool for identifying and excluding non-sarcopenic geriatric patients. Furthermore, the SARC-F score was more strongly correlated with reduced muscle strength and physical function than with low muscle mass.

Older patients with cancer are underrepresented in trials investigating the effect of exercise therapy. The aim of this systematic review was to investigate the effect of exercise therapy during medical antineoplastic treatment in older patients (≥ 65 years) with cancer. A systematic review following the Cochrane guidelines was performed. Randomized controlled trials were identified through a systematic literature search in MEDLINE, EMBASE, CENTRAL, and CINAHL up to December 2019. Study selection was performed independently by two reviewers. Four randomized controlled trials published between 2014 and 2019 were included comprising a total of 412 participants. Most participants were diagnosed with breast, prostate or colorectal cancer. The studies were characterized by large differences in design, interventions and outcomes, which prevented meta-analyses. The interventions ranged from 4 weeks to 12 months and involved both supervised and unsupervised exercise programs. Some evidence of beneficial effects from the interventions were documented on physical function, muscle strength, physical activity and cognitive function. No evidence of effects was found for health-related quality of life, aerobic capacity, body composition, cancer-related symptoms and side effects, or for any clinical outcomes. No adverse events were reported. Exercise therapy seems to be safe and feasible in older patients with cancer. However, due to a limited number of studies, small sample sizes and heterogeneity across study design, the effects of exercise in older patients with cancer receiving medical antineoplastic treatment are inconclusive.

Purpose To investigate the predictive value of New Mobility Score, de Morton Mobility Index, and Cumulated Ambulation Score regarding discharge destination, and to determine the feasibility of the tests in an acute geriatric ward. Materials and methods Observational 1-year cohort study of 491 geriatric patients admitted consecutively from own home. New Mobility Score (pre-hospital functional level), de Morton Mobility Index, and Cumulated Ambulation Score were recorded at the first physiotherapy contact. Results Univariable logistic regression showed that the odds for not being discharged home were 7 times higher (odds ratio = 7.6, 95%CI; 4.5-12.7) for patients with a non-independent mobility level (Cumulated Ambulation Score ≤ 5) compared to independent (Cumulated Ambulation Score = 6). Corresponding ratios were 6.2 (3.8-10.0) for de Morton Mobility Index ≤ 41 points and 2.8 (1.8-4.5) for New Mobility Score ≤5 points. Adjustment for gender, age, cause of admission, and marital status improved the predictive value of the Cumulated Ambulation Score. Upon admission, 99% of the patients were assessed with New Mobility Score, 100% with Cumulated Ambulation Score, and 81% with de Morton Mobility Index. Conclusion Cumulated Ambulation Score is more feasible and superior in predicting discharge destination than de Morton Mobility Index and New Mobility Score in an acute geriatric ward. Implications for rehabilitation Easy, quick, and accurate measurement of mobility is essential for discharge planning and effective targeting of physiotherapy in an acute geriatric ward. The objectively assessed Cumulated Ambulation Score is superior to the de Morton Mobility Index and the pre-hospital New Mobility Score in predicting discharge destination in geriatric patients admitted from their own home. The Cumulated Ambulation Score and the New Mobility Score are more feasible and less time consuming to complete in an acute geriatric ward compared to the de Morton Mobility Index.

Post-approval changes are inevitable and necessary throughout the life of a drug product-to implement new knowledge, maintain a state of control, and drive continual improvement. Many post-approval changes require regulatory agency approval by individual countries before implementation. Because of the global regulatory complexity, individual post-approval changes usually take years for full worldwide approval even when they reduce patient risk, improve compliance, or enhance the manufacturing process or test methods. This global complexity slows down continual improvement and innovation and can cause drug shortages and current good manufacturing practices compliance issues. Manufacturers that market products globally experience the greatest challenge and risks in their daily operations because of this post-approval change complexity. A global problem needs a global solution. This paper has been sponsored and endorsed by senior quality leaders (Chief Quality Officers/Heads of Quality) from20 global pharmaceutical companies who have collaborated to speak with "One-Voice-Of-Quality" (1VQ). The paper provides two specific solutions that lay the foundation for an aligned and standardized industry position on the topic of effective management of post-approval changes in the pharmaceutical quality system (PQS). This document represents the 1VQ standard approach for the steps necessary to establish and demonstrate an effective quality system to fully leverage a risk-based approach to post-approval changes as laid out by ICH Q10 Annex 1. Implementation of the solutions presented in this paper can help achieve a transformational shift with faster implementation of new knowledge, continual improvement, and innovation through post-approval changes. The Chief Quality Officers/Heads of Quality are inviting other companies to join the 1VQ (contact either Emma Ramnarine or Anders Vinther) and other stakeholders to join the dialog.

The incidence of colorectal cancer (CRC) increases with older age. Cancer and treatment-related side effects often lead to physical decline, poor treatment adherence, and a lower quality of life. The aim of the present systematic review and meta-analysis was to evaluate the effects of exercise reported by randomized controlled trials (RCTs) on physical function, physical fitness (ie, aerobic capacity, muscle strength) physical activity, and psychological well-being in older patients with CRC undergoing chemotherapy. Eight RCTs with 552 participants were included in the meta-analysis. The mean age across the RCTs was 58.5 years, and 2 RCTs excluded patients aged > 80 years. The meta-analyses showed a low level of evidence for a small beneficial effect of exercise on self-reported physical function (standardized mean difference [SMD], 0.26; 95% confidence interval [CI], 0.04-0.48) and global quality of life (SMD, 0.22; 95% CI, 0.02-0.43) and low level of evidence for a moderate effect of exercise reducing fatigue (SMD, −0.49; 95% CI, −0.79 to −0.19) for patients receiving chemotherapy for CRC. We found no evidence for a beneficial effect of exercise on physical fitness. No adverse events related to the exercise interventions were reported. The evidence for the effect of exercise on physical outcomes and psychological well-being during chemotherapy for patients with CRC and especially for older patients is sparse. However, exercise during chemotherapy for patients with CRC is feasible and safe. We found a moderate to high risk of bias in most of the included studies, small sample sizes, and a low number of included patients. Moreover, all studies had excluded patients with comorbidities or walking impairment, a group of patients who would probably benefit the most from exercise. This positive result requires verification in larger trials of older and frail patients receiving chemotherapy for CRC.

Aim The aim of this work was to examine (1) the incidence of primary repair, (2) the incidence of recurrent repair and (3) the types of repair performed in patients with parastomal bulging. Method Prospectively collected data on parastomal bulging from the Danish Stoma Database were linked to surgical data on repair of parastomal bulging from the Danish National Patient Register. Survival statistics provided cumulative incidences and time until primary and recurrent repair. Results In the study sample of 1016 patients with a permanent stoma and a parastomal bulge, 180 (18%) underwent surgical repair. The cumulative incidence of a primary repair was 9% [95% CI (8%; 11%)] within 1 year and 19% [95% CI (17%; 22%)] within 5 years after the occurrence of a parastomal bulge. We found a similar probability of undergoing primary repair in patients with ileostomy and colostomy. For recurrent repair, the 5-year cumulative incidence was 5% [95% CI (3%; 7%)]. In patients undergoing repair, the probability was 33% [95% CI (21%; 46%)] of having a recurrence requiring repair within 5 years. The main primary repair was open or laparoscopic repair with mesh (43%) followed by stoma revision (39%). Stoma revision and repair with mesh could precede or follow one another as primary and recurrent repair. Stoma reversal was performed in 17% of patients. Conclusion Five years after the occurrence of a parastomal bulge the estimated probability of undergoing a repair was 19%. Having undergone a primary repair, the probability of recurrent repair was high. Stoma reversal was more common than expected.

It is important to identify, assess, and address current barriers to implementation of post-approval changes that are intended to ensure continued (uninterrupted) operations and drive innovation and continual improvement in a maximally efficient, agile, and flexible pharmaceutical manufacturing sector. Leveraging the International Conference for Harmonisation Quality Guideline Q10 provides regulatory relief when it comes to addressing changes related to excipients, specifically excipient supplier's name and address changes, which will ensure a sustainable, reliable global supply and the availability of high quality product to patients through the entire commercial lifecycle of a product without extensive regulatory oversight.

Summary Background Rib pain is a common complaint among rowers and can lead to significant time loss from sport. Recent literature has emerged regarding rib stress injury (RSI) prevention and management. The aim of the present review was to update current knowledge regarding risk factors and injury mechanisms of RSI in rowers and suggest strategies for clinical application of this emerging evidence as well as suggest future areas of study. Material and methods Existing literature on RSI risk factors and mechanisms, and on research methodology in overuse injuries in general, was reviewed. Results Search results revealed several intrinsic and extrinsic factors related to rib stress and its response, including detrimental muscle loading of the ribs, low energy availability (LEA) and the potential influence of ergometer rowing. Conclusions Emerging issues regarding risk factors and mechanisms in RSI may help inform clinical application and future research. There remains a pressing need for further studies regarding RSI aetiology and epidemiology to guide effective prevention strategies, particularly in subgroups such as para rowers and non-elites.

Objectives Patients with head and neck squamous cell carcinoma undergoing concomitant chemoradiotherapy (CCRT) frequently experience weight loss, especially loss of lean body mass (LBM), and reduced functional performance. This study investigated whether a 12-week hospital-based progressive resistance training (PRT) program during CCRT is feasible in the clinical setting before planning initiation of a larger randomized study which is the long-term goal. Study design Prospective pilot study. Methods Twelve patients receiving CCRT were planned to attend a 12-week PRT program. Primary endpoint was feasibility measured as attendance to training sessions. Secondary endpoints included changes in functional performance, muscle strength, and body composition measured by Dual-energy X-ray Absorptiometry (DXA) scans. Furthermore, sarcomeric protein content, pentose phosphate pathway (PPP) activity, and glycolysis were determined in muscle biopsies. Results Twelve patients with p16 positive oropharyngeal cancer were enrolled. The primary endpoint was met with 9 of the 12 patients completing at least 25 of 36 planned training sessions. The mean attendance rate was 77%. Functional performance was maintained during the treatment period and increased during follow-up (p

Background Physical exercise is generally recommended as part of life style changes post stroke. Monitoring cardiovascular effects may help motivate patients for further exercise, and can be an instrument to assess intervention effects in clinical trials. In 1 of 4 stroke patients, the heart rate variability may challenge currently used cardiovascular monitoring. The Graded Cycling Test with Talk Test is a submaximal exercise test independent of heart rate variability, shown reliable for patients with cardiac disease. Methods Patients diagnosed with lacunar stroke according to TOAST (Trial of Org 10172 in Acute Stroke Treatment) criteria performed an incremental exercise test on a stationary bicycle with a 15 W (watt) increase in workload every minute. Toward the end of each incremental step, the patients recited a standardized text passage and subsequently were asked: "Are you still able to speak comfortably?" The test was stopped when the patients were no longer able to speak comfortably. Two consecutive tests were performed separated by 1 hour rest. Results Sixty patients completed the study. The intraclass correlation coefficient (ICC 2.1 ) was as follows: .97 [95% CI: .95-.98] with only a minor measurement error: 12.9 W for groups of patients (standard error of measurement, SEM 95 ) and 18.3 W for individual patients (smallest real difference). Conclusion The "Graded Cycling Test with Talk Test" is feasible and reliable for monitoring exercise effects in patients with lacunar stroke. The high ICC 2.1 and small measurement error suggest it to be a valuable outcome measurement in clinical practice.