Walking Football as a Supportive Medicine for Patients With Prostate Cancer

Study Overview
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Brief Summary
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Androgen deprivation therapy (ADT) is widely used in men with prostate cancer (PCa) to delay disease progression and enhance survival. The use of ADT is often associated with a vast spectrum of side effects that considerably reduce quality of life. Exercise has been proposed as a non-pharmacological strategy to counter some adverse effects of ADT among patients with PCa. Particularly, recreational football-based interventions have been suggested as an enjoyment approach to involve patients with PCa in regular exercise practice. Given its intermittent nature and vigorous efforts, adverse events associated with recreational football practice have been reported. To handle this issue and to involve patients with PCa in recreational football practice, walking football has emerged as a more suitable exercise modality

Detailed Description
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This study was design as a randomized controlled trial, with two study arms, which aims to analyse the feasibility, safety of a supervised walking football program in patients with PCa. Moreover, the effects on health-related quality of life; bone mineral density; body composition; physical fitness; physical activity levels; inflammatory and metabolic profile; cognitive function; and cost-effectiveness will be complementarily analysed. Recruitment will be conducted by invitation of Centro Hospitalar de Vila Nova de Gaia/Espinho (CHVNG/E; Vila Nova de Gaia, Portugal, E.P.E) oncologists and urologists. Patients who agree to participate in this study will be referred to a study coordinator (medical oncologist) and will be randomly allocated (1:1 ratio) to one of the two study-arms. In addition to standard PCa care, patients in the interventional group (IG) will perform 3 times per week a supervised Walking Football Program over 16 weeks and plus 16 additional weeks. Patients allocated to control group (CG) will receive standard PCa medical care and will be instructed to maintain daily-life routines. After the first 16 weeks, the control group patients' will be invited to join and preform the exercise intervention (additional 16 weeks). Walking football exercise sessions will be conducted on an indoor sports hall, supervised by one exercise physiologist and a football coach. Exercise intensity will be monitored through heart rate and rated perceived exertion.

Official Title
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Is the Walking Football a Feasible Approach to Improve Health-related Quality of Life in Men With Prostate Cancer Receiving Androgen Deprivation Therapy? the PROSTATA_MOVE Randomized Controlled Trial.

Conditions
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Prostate Cancer, Androgen Deprivation Therapy

Intervention / Treatment
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* Behavioral: Walking football training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with PCa Under castration therapy for more than 3 months Planned to be under castration for more than 6 months Follow-up at the Medical Oncology department and/or Urology department of the Hospital Center Vila Nova de Gaia/Espinho. Exclusion Criteria: Medical or surgical contraindications for exercise. T-score < -2.5

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Interventional group<br>Walking football training | Behavioral: Walking football training<br>* Intervention will involve 3 sessions per week of a structured and supervised walking football program over 16 weeks. Each session will include a warm-up, followed by the practice of specific exercises where specific technical skills (pass, dribble, shot), motor skills (agility, coordination, balance) and physical fitness (cardiorespiratory and musculoskeletal capacity) will be enhanced, ending with a structured game (7x7) of walking football and a cooldown.<br>* Other names: Exercise training;|
| No Intervention: Control group<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate. | Assessed by the number of enrolled patients divided by the number of invited patients. | Baseline | 
| Withdrawal rate | Assessed by the number of withdrawal patients | Change from baseline to 32 weeks | 
| Appropriateness of outcomes assessments. | Assessed by the percentage of completed data. | Change from baseline to 32 weeks | 
| Adherence to intervention. | Assessed by the number of completed sessions and the number of missed sessions. | Change from baseline to 32 weeks | 
| Rate of Enjoyment | Assessed by the self-reported exercise sessions' enjoyment using a likert scale (1 [lowest] to 5 [highest] points). | Change from baseline to 32 weeks | 
| Health-related quality of life | Using EORTC PR25, EQ-5D-5L and SF-6D questionnaire. | Change from baseline to 32 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density | Assessed by a whole-body dual-energy X-ray absorptiometry (DXA) scan. | Change from baseline to 32 weeks | 
| Body composition | Assessed by a whole-body dual-energy X-ray absorptiometry (DXA) scan. | Change from baseline to 32 weeks | 
| Aerobic capacity | Assessed by a symptom-limited exercise test on a treadmill | Change from baseline to 32 weeks | 
| Maximal isometric handgrip strength | Assessed using a digital handgrip dynamometer. | Change from baseline to 32 weeks | 
| Maximal isometric lower limb strength | Assessed using a digital handgrip dynamometer. | Change from baseline to 32 weeks | 
| Lower limb functionality | Assessed by the 30-seconds sit-to-stand test | Change from baseline to 32 weeks | 
| Static balance | Assessed by the single leg stance test | Change from baseline to 32 weeks | 
| Habitual physical activity levels | Assessed using accelerometers | Change from baseline to 32 weeks | 
| Exercise intensity - External load | Distance (km) assessed using GPS tracking during exercise | Change from baseline to 32 weeks | 
| Exercise intensity - Internal load | Assessed by the heart rate | Change from baseline to 32 weeks | 
| Exercise intensity - Rating of perceived exertion | Assessed using a 6-20 borg scale (minimum effort = 6; maximum effort = 10). | Change from baseline to 32 weeks | 
| Cogntive function | Assessed by the Montreal Cognitive Assessment | Change from baseline to 32 weeks | 
| Blood pressure | Assessed using a digital sphygmomanometer | Change from baseline to 32 weeks | 
| Resting heart rate | Assessed using a digital sphygmomanometer | Change from baseline to 32 weeks | 
| LDL-cholesterol | Blood sample will be taken for analysis of levels of LDL-cholesterol | Change from baseline to 32 weeks | 
| HDL-cholesterol | Blood sample will be taken for analysis of levels of HDL-cholesterol | Change from baseline to 32 weeks | 
| Total cholesterol | Blood sample will be taken for analysis of levels of total cholesterol | Change from baseline to 32 weeks | 
| Triglycerides | Blood sample will be taken for analysis of levels of triglycerides | Change from baseline to 32 weeks | 
| Prostate specific antigen (PSA) | Blood sample will be taken for analysis of levels of PSA | Change from baseline to 32 weeks | 
| Creatinine | Blood sample will be taken for analysis of levels of creatinine | Change from baseline to 32 weeks | 
| High sensitivity C-reactive protein (HS-CRP) | Blood sample will be taken for analysis of levels of HS-CRP | Change from baseline to 32 weeks | 
| N-terminal type B natriuretic peptide (NT-proBNP) | Blood sample will be taken for analysis of levels of NT-proBNP | Change from baseline to 32 weeks | 
| Vitamin D | Blood sample will be taken for analysis of levels of vitamin D | Change from baseline to 32 weeks | 
| Osteocalcin | Blood sample will be taken for analysis of levels of | Change from baseline to 32 weeks | 
| C-Telopeptide of Collagen Cross-links (CTx) | Blood sample will be taken for analysis of levels of CTx | Change from baseline to 32 weeks | 
| Bone Specific Alkaline Phosphatase (BSAP) | Blood sample will be taken for analysis of levels of BSAP | Change from baseline to 32 weeks | 
| Tartrate-Resistant Acid Phosphatase (TRAP) | Blood sample will be taken for analysis of levels of TRAP | Change from baseline to 32 weeks | 
| Glycated hemoglobin | Blood sample will be taken for analysis of levels of glycated hemoglobin | Change from baseline to 32 weeks | 
| Testosterone | Blood sample will be taken for analysis of levels of testosterone | Change from baseline to 32 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Androgen Deprivation Therapy, Walking football