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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
50
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.
Centro Hospitalar Vila Nova de Gaia / Espinho
Vila Nova de Gaia, Portugal
Recruitment rate.
Assessed by the number of enrolled patients divided by the number of invited patients.
Time frame: Baseline
Withdrawal rate
Assessed by the number of withdrawal patients
Time frame: Change from baseline to 32 weeks
Appropriateness of outcomes assessments.
Assessed by the percentage of completed data.
Time frame: Change from baseline to 32 weeks
Adherence to intervention.
Assessed by the number of completed sessions and the number of missed sessions.
Time frame: 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).
Time frame: Change from baseline to 32 weeks
Health-related quality of life
Using EORTC PR25, EQ-5D-5L and SF-6D questionnaire.
Time frame: Change from baseline to 32 weeks
Bone Mineral Density
Assessed by a whole-body dual-energy X-ray absorptiometry (DXA) scan.
Time frame: Change from baseline to 32 weeks
Body composition
Assessed by a whole-body dual-energy X-ray absorptiometry (DXA) scan.
Time frame: Change from baseline to 32 weeks
Aerobic capacity
Assessed by a symptom-limited exercise test on a treadmill
Time frame: Change from baseline to 32 weeks
Maximal isometric handgrip strength
Assessed using a digital handgrip dynamometer.
Time frame: Change from baseline to 32 weeks
Maximal isometric lower limb strength
Assessed using a digital handgrip dynamometer.
Time frame: Change from baseline to 32 weeks
Lower limb functionality
Assessed by the 30-seconds sit-to-stand test
Time frame: Change from baseline to 32 weeks
Static balance
Assessed by the single leg stance test
Time frame: Change from baseline to 32 weeks
Habitual physical activity levels
Assessed using accelerometers
Time frame: Change from baseline to 32 weeks
Exercise intensity - External load
Distance (km) assessed using GPS tracking during exercise
Time frame: Change from baseline to 32 weeks
Exercise intensity - Internal load
Assessed by the heart rate
Time frame: 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).
Time frame: Change from baseline to 32 weeks
Cogntive function
Assessed by the Montreal Cognitive Assessment
Time frame: Change from baseline to 32 weeks
Blood pressure
Assessed using a digital sphygmomanometer
Time frame: Change from baseline to 32 weeks
Resting heart rate
Assessed using a digital sphygmomanometer
Time frame: Change from baseline to 32 weeks
LDL-cholesterol
Blood sample will be taken for analysis of levels of LDL-cholesterol
Time frame: Change from baseline to 32 weeks
HDL-cholesterol
Blood sample will be taken for analysis of levels of HDL-cholesterol
Time frame: Change from baseline to 32 weeks
Total cholesterol
Blood sample will be taken for analysis of levels of total cholesterol
Time frame: Change from baseline to 32 weeks
Triglycerides
Blood sample will be taken for analysis of levels of triglycerides
Time frame: Change from baseline to 32 weeks
Prostate specific antigen (PSA)
Blood sample will be taken for analysis of levels of PSA
Time frame: Change from baseline to 32 weeks
Creatinine
Blood sample will be taken for analysis of levels of creatinine
Time frame: 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
Time frame: 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
Time frame: Change from baseline to 32 weeks
Vitamin D
Blood sample will be taken for analysis of levels of vitamin D
Time frame: Change from baseline to 32 weeks
Osteocalcin
Blood sample will be taken for analysis of levels of
Time frame: Change from baseline to 32 weeks
C-Telopeptide of Collagen Cross-links (CTx)
Blood sample will be taken for analysis of levels of CTx
Time frame: Change from baseline to 32 weeks
Bone Specific Alkaline Phosphatase (BSAP)
Blood sample will be taken for analysis of levels of BSAP
Time frame: Change from baseline to 32 weeks
Tartrate-Resistant Acid Phosphatase (TRAP)
Blood sample will be taken for analysis of levels of TRAP
Time frame: Change from baseline to 32 weeks
Glycated hemoglobin
Blood sample will be taken for analysis of levels of glycated hemoglobin
Time frame: Change from baseline to 32 weeks
Testosterone
Blood sample will be taken for analysis of levels of testosterone
Time frame: Change from baseline to 32 weeks
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