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.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Recruitment rate.
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Recruitment rate.
Time Frame: Baseline
Assessed by the number of enrolled patients divided by the number of invited patients.
Withdrawal rate
Time Frame: Change from baseline to 32 weeks
Assessed by the number of withdrawal patients
Appropriateness of outcomes assessments.
Time Frame: Change from baseline to 32 weeks
Assessed by the percentage of completed data.
Adherence to intervention.
Time Frame: Change from baseline to 32 weeks
Assessed by the number of completed sessions and the number of missed sessions.
Rate of Enjoyment
Time Frame: Change from baseline to 32 weeks
Assessed by the self-reported exercise sessions' enjoyment using a likert scale (1 \[lowest\] to 5 \[highest\] points).
Health-related quality of life
Time Frame: Change from baseline to 32 weeks
Using EORTC PR25, EQ-5D-5L and SF-6D questionnaire.
Secondary Outcomes
- Body composition(Change from baseline to 32 weeks)
- Aerobic capacity(Change from baseline to 32 weeks)
- Maximal isometric handgrip strength(Change from baseline to 32 weeks)
- Maximal isometric lower limb strength(Change from baseline to 32 weeks)
- Bone Mineral Density(Change from baseline to 32 weeks)
- Lower limb functionality(Change from baseline to 32 weeks)
- Static balance(Change from baseline to 32 weeks)
- Habitual physical activity levels(Change from baseline to 32 weeks)
- Exercise intensity - External load(Change from baseline to 32 weeks)
- Exercise intensity - Internal load(Change from baseline to 32 weeks)
- Exercise intensity - Rating of perceived exertion(Change from baseline to 32 weeks)
- Cogntive function(Change from baseline to 32 weeks)
- Blood pressure(Change from baseline to 32 weeks)
- Creatinine(Change from baseline to 32 weeks)
- High sensitivity C-reactive protein (HS-CRP)(Change from baseline to 32 weeks)
- Bone Specific Alkaline Phosphatase (BSAP)(Change from baseline to 32 weeks)
- Resting heart rate(Change from baseline to 32 weeks)
- LDL-cholesterol(Change from baseline to 32 weeks)
- Total cholesterol(Change from baseline to 32 weeks)
- N-terminal type B natriuretic peptide (NT-proBNP)(Change from baseline to 32 weeks)
- Vitamin D(Change from baseline to 32 weeks)
- Osteocalcin(Change from baseline to 32 weeks)
- HDL-cholesterol(Change from baseline to 32 weeks)
- Triglycerides(Change from baseline to 32 weeks)
- Prostate specific antigen (PSA)(Change from baseline to 32 weeks)
- C-Telopeptide of Collagen Cross-links (CTx)(Change from baseline to 32 weeks)
- Tartrate-Resistant Acid Phosphatase (TRAP)(Change from baseline to 32 weeks)
- Glycated hemoglobin(Change from baseline to 32 weeks)
- Testosterone(Change from baseline to 32 weeks)
Investigators
Andreia Capela
Medical oncologist at Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Associacao de Investigacao de Cuidados de Suporte em Oncologia