Value of gym-based group exercise versus usual care for young adults receiving antipsychotic medication: study protocol for the multicenter randomized controlled Vega trial.

BACKGROUND: Exercise is recommended to protect physical health among people with severe mental illness and holds the potential to facilitate long-term recovery. An inclusive exercise community provides an opportunity for life skill training and social connectedness and may reduce the experience of loneliness and internalized stigmatization which together may improve personal recovery. Using a pragmatic randomized design, we aim to examine the effectiveness of a gym-based exercise intervention tailored to young adults in antipsychotic treatment (i.e., Vega Exercise Community) compared to usual care. It is hypothesized that the Vega Exercise Community will be superior to usual care for personal recovery at four months. METHODS: The trial will be conducted at four sites in Denmark from which 400 participants, aged 18 to 35 years, who are in current treatment with antipsychotic medications for the management of schizophrenia spectrum or affective disorders, will be recruited. Participants will be randomized (2:1) to Vega Exercise Community or usual care. Vega Exercise Community includes three weekly group-based exercise sessions hosted in commercial functional training centers delivered by certified Vega instructors. After four months, participants in Vega Exercise Community will be randomized (1:1) to minimal versus extended support with regards to sustained physical activity. Data will be collected at baseline, four, six and 12 months. The primary outcome is personal recovery assessed by Questionnaire about the Process of Recovery at four months. Behavioral symptoms, health-related quality of life, metabolic health, and program costs will be evaluated to further determine the effectiveness and cost-effectiveness of the Vega Exercise Community. Finally, the quality of life and physical and mental health of the participants' primary relative will be evaluated. DISCUSSION: The results of this trial may have important implications for health, sustained physical activity, and recovery for individuals in treatment with antipsychotics. Given the pragmatic design, positive results may readily be implemented by mental health care professionals to promote exercise as an integrated part of treatment of severe mental illness. TRIAL REGISTRATION: Clinical Trials.gov (NCT05461885, initial registration June 29th, 2022). WHO Universal Trial Number (UTN): U1111-1271-9928.

Easier in Practice Than in Theory: Experiences of Coaches in Charge of Community-Based Soccer Training for Men with Prostate cancer-A Descriptive Qualitative Study.

BACKGROUND: Evidence suggests that community-based exercise programs and sports participation benefit long-term physical activity adherence and promote health in clinical populations. Recent research shows that community-based soccer can improve mental health and bone health and result in fewer hospital admissions in men with prostate cancer. However, little knowledge exists on what coaches experience, leading to a scarcity of knowledge on how to assist them in promoting and supporting the sustainability of programs. The purpose of this study was to explore the experiences of non-professional soccer coaches in providing community-based soccer training for men with prostate cancer. RESULTS: We interviewed 13 out of 21 eligible non-professional soccer coaches in charge of delivering the Football Club Prostate Community program, which is community-based soccer training for men with prostate cancer at 12 local soccer clubs across Denmark. Qualitative content analysis, as described by Graneheim and Lundman, was applied to analyze the data using NVivo 12 software. We identified the five following overall categories with 10 subcategories on what the coaches experienced: (1) enabling training of a clinical population in a community setting, (2) dedication based on commitment, (3) coaching on the players' terms, (4) navigating the illness, and (5) ensuring sustainability. Collectively, the findings suggest that, while the coaches felt adequately prepared to coach, their coaching role developed and was refined only through interaction with the players, indicating that coaching clinical populations may be easier in practice than in theory and a potentially transformative learning experience. CONCLUSIONS: Non-professional soccer coaches in charge of delivering soccer training for men with prostate cancer value being educated about specific illness-related issues. Initial concerns about how to coach a clinical population disappeared once the coaches engaged with the players and developed their own team norms and illness management strategies. They also gained a broader perspective on their own lives, which they valued and would not otherwise have achieved by coaching a healthy population. Our study indicates that sustainable implementation and the program's sustainability can be promoted and supported through additional formal, easily accessible communication with trained health professionals and by networking with peer coaches.

Do Patients with Prostate Cancer Benefit from Exercise Interventions? A Systematic Review and Meta-Analysis.

Men diagnosed and treated for prostate cancer experience severe adverse effects on quality of life (QoL) and metabolic health, some of which may be preventable or reversible with exercise, the benefits of which healthcare providers and patients increasingly acknowledge, though existing evidence on its effects varies in significance and magnitude. We aimed to review the effect of exercise on QoL and metabolic health in a broad prostate cancer population. A systematic search was conducted in nine databases and eligible trials were included in the meta-analytic procedure. All outcomes were stratified into aerobic exercise, resistance exercise, and a combination of both. The review identified 33 randomised controlled trials (2567 participants) eligible for inclusion. Exercise had a borderline small positive effect on cancer-specific QoL (standardised mean difference (SMD) = 0.10, 95% confidence interval (CI) -0.01-0.22), and a moderate to large effect on cardiovascular fitness (SMD = 0.46, 95% CI 0.34-0.59) with aerobic exercise being the superior modality (SMD = 0.60, 95% CI 0.29-0.90). A positive significant effect was seen in lower body strength, whole-body fat mass, general mental health, and blood pressure. No significant effect was seen in fatigue, lean body mass, and general physical health. We thereby conclude that exercise is effective in improving metabolic health in men diagnosed with prostate cancer, with aerobic exercise as the superior modality. The effect of exercise on QoL was small and not mediated by choice of exercise modality.

Safety and Effects of Football in Skeletal Metastatic Prostate Cancer: a Subgroup Analysis of the FC Prostate Community Randomised Controlled Trial.

BACKGROUND: Skeletal metastatic disease excludes many cancer patients from participating in exercise and physical activity due to safety concerns. Empirical evidence from high-quality trials is warranted to guide clinicians and patients. OBJECTIVE: To evaluate the safety and potential benefits of high-impact aerobic exercise in patients with prostate cancer with skeletal metastases. DESIGN: Exploratory subgroup analysis of a pragmatic, multicentre, parallel randomised controlled trial. SETTING: The trial recruited 214 patients from five hospital urological departments in Denmark. PARTICIPANTS: Patients with prostate cancer with skeletal metastases (n = 41). INTERVENTION: Six months of football training twice weekly at a local club or usual care. Both groups received brief information on physical activity recommendations at the time of randomisation. MAIN OUTCOME(S) AND MEASURE(S): Safety, defined as falls, fractures and hospital admissions. Effects were evaluated on the primary outcome (prostate cancer-specific quality of life) and secondary outcomes (lean body mass, fat mass, hip and spine bone mineral density, and general physical and mental health). RESULTS: The original trial comprised 214 participants, 41 of whom had skeletal metastases at enrolment. Of these, 22 were allocated to football and 19 to usual care. The trial retention rate was 95% at 12 weeks and 88% at 6 months. Football participants attended 13 sessions on average at 12 weeks and 23 at 6 months. There were two falls, one in each group after 6 months, and no fractures. There were four unplanned hospital admissions in the study period, all four in the usual care group. Statistically significant between-group difference was observed in the primary outcome change in prostate cancer-specific quality of life at 12 weeks (7.6 points [95% CI 0.5 to 15.0]; P = 0.038). No statistical changes were found in the secondary outcomes. CONCLUSION: The analysis showed that football training was safe in patients with skeletal metastatic prostate cancer and significantly improved quality of life. Larger analyses and/or trials are warranted to confirm the safety of exercise more broadly in cancer patients with skeletal metastatic disease. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02430792 . Date of registration 30 April 2015.

Community-based football in men with prostate cancer: 1-year follow-up on a pragmatic, multicentre randomised controlled trial.

BACKGROUND: Physical exercise has been shown to be effective in relation to fatigue, aerobic fitness, and lower body strength in men with prostate cancer. However, research into the clinically relevant effects of interventions conducted in heterogeneous patient populations and in real-life clinical practice settings is warranted. METHODS AND FINDINGS: We conducted a pragmatic, multicentre, parallel randomised controlled trial in 5 Danish urological departments. Recruitment began in May 2015, the first participant was randomised in June 2015, and the last participant was included in February 2017. In total, 214 men with prostate cancer were randomly assigned to either 6 months of free-of-charge football training twice weekly at a local club (football group [FG]) (n = 109) or usual care (usual care group [UG]) (n = 105), including brief information on physical activity recommendations at randomisation. Participants were on average 68.4 (SD 6.2) years old, 157 (73%) were retired, 87 (41%) were on castration-based treatment, 19 (9%) had received chemotherapy, and 41 (19%) had skeletal metastases at baseline. In this 1-year follow-up study, we evaluated the effects of community-based football training on the following outcomes: primary outcome, quality of life; secondary outcomes: continuation of football after 6 months, hip and lumbar spine bone mineral density (BMD), mental health score, fat and lean body mass, and safety outcomes, i.e., fractures, falls, and hospital admissions. Intention to treat (ITT) and per protocol (PP) analyses were conducted. No statistically significant between-group difference was observed in change in prostate-cancer-specific quality of life (ITT: 1.9 points [95% CI -1.9 to 5.8], p = 0.325; PP: 3.6 points [95% CI -0.9 to 8.2], p = 0.119). A statistically significant between-group difference was observed in change in total hip BMD, in favour of FG (0.007 g/cm2 [95% CI 0.004 to 0.013], p = 0.037). No differences were observed in change in lumbar spine BMD or lean body mass. Among patients allocated to football, 59% chose to continue playing football after the end of the 6-month intervention period. At 1-year follow-up in the PP population, FG participants had more improvement on the Mental Component Summary (2.9 [95% CI 0.0 to 5.7], p = 0.048 points higher) than UG participants, as well as a greater loss of fat mass (-0.9 kg [95% CI -1.7 to -0.1], p = 0.029). There were no differences between groups in relation to fractures or falls. Hospital admissions were more frequent in UG compared to FG (33 versus 20; the odds ratio based on PP analysis was 0.34 for FG compared to UG). There were 3 deaths in FG and 4 in UG. Main limitations of the study were the physically active control group and assessment of physical activity by means of self-report. CONCLUSIONS: In this trial, participants allocated to football appeared to have improved hip BMD and fewer hospital admissions. Men who played football more than once a week for 1 year lost fat mass and reported improved mental health. Community-based football proved to be acceptable, even when club membership was not subsidised. TRIAL REGISTRATION: ClinicalTrials.gov NCT02430792.

Football Compared with Usual Care in Men with Prostate Cancer (FC Prostate Community Trial): A Pragmatic Multicentre Randomized Controlled Trial.

BACKGROUND: Physical activity has been shown to mitigate the unwanted psychological and physiological side effects of prostate cancer treatments, but sustainable exercise possibilities are limited. OBJECTIVE: Our objective was to examine whether football in a real-world setting (i.e., local football clubs) was safe and feasible in practice and could improve quality of life, mitigate decline in muscle mass and bone density, and increase fat mass in patients with prostate cancer. METHODS: In this pragmatic, multicentre, parallel randomized controlled trial, men diagnosed with prostate cancer were recruited from five Danish urological departments. Men (N = 214) diagnosed with prostate cancer were randomly allocated, using random generated lists (block size 4-8) stratified for center and androgen-deprivation therapy status, to either 1 h of football twice weekly in a local football club or to usual care, which was a 15- to 30-min telephone session covering their options for physical activity or free-of-charge rehabilitation delivered as standard in Denmark. Allocation was concealed from the trial investigator performing the randomization, but-given the nature of the intervention-this was not possible for personnel and participants. Assessments were performed at baseline, 12 weeks, and 6 months. The primary outcome was mean change difference in prostate cancer-specific quality of life at 12 weeks. Secondary outcomes were body composition, 12-Item Short Form Health Survey (SF-12) physical and mental health, and safety-reported as fractures, falls, and serious adverse events. RESULTS: Attrition was 1 and 3% at 12 weeks, and 5% and 5% at 6 months for the usual care and football groups, respectively. Prostate cancer-specific quality of life was equal between groups at 12 weeks (mean difference + 1.9 points, 95% confidence interval [CI] -1.0-4.8; P = 0.20) and at 6 months (+ 0.5 points, 95% CI -2.8-3.8; P = 0.76). Fractures were equally distributed, with two fractures in the usual care group and one in the football group. Likewise, body composition outcomes were equal. Mental health improved after 6 months of football (mean difference + 2.7 points, 95% CI 0.8-4.6; P = 0.006). CONCLUSIONS: In this trial, community-based football was a feasible exercise strategy for men with prostate cancer. Football did not improve prostate cancer-specific quality of life but did improve mental health; the clinical significance of this is unclear. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02430792.

Development of an Educational Program for Non-Professional Soccer Coaches in Charge of Community-Based Soccer in Men with Prostate Cancer: a Qualitative Study.

BACKGROUND: While clinical trials have demonstrated the benefits of structured exercise for prostate cancer survivors, few attempts have been made to investigate and implement sustainable community-based exercise programs supporting adoption of long-term physical activity behavior. Against this background, the aims of this study was to explore the perspectives of experts and stakeholders on the development of a training course and intervention manual used to support the delivery of community-based soccer training in men with prostate cancer (the FC Prostate Community [FCPC] trial). METHODS: A two-step qualitative design including triangulation of methods, data sources, and researchers. Step 1 comprised key informant interviews with clinical and scientific experts (n = 4). Step 2 included stakeholder focus group interviews with nurses (n = 5), non-professional soccer coaches and club representatives (n = 5), and prostate cancer survivors (n = 7). RESULTS: Four themes emerged from the analysis of the key informant interviews: The Coach's Qualifications, Structure of the Training, Prevention of Injuries, and A Non-Patient Environment, which informed development of the training course and intervention manual. The stakeholders added the importance of clarifying the Responsibility of the Coach, the value of Positive Competition, and Social Inclusion of the prostate cancer survivors in the club. Based on these results, we present the final templates for the training course and intervention manual. CONCLUSIONS: No general set of rules or safety measures to promote or optimize the delivery of community-based exercise in cancer survivors is recommended. However, the general principles related to the necessary clarification of the coach's responsibility in relation to the prevention and management of injuries and participant adherence through a non-patient environment may be transferable to the training and education of other groups of lay persons in charge of delivering exercise interventions to other clinical subpopulations in a non-hospital setting.