Walking Football as a Supportive Medicine for Patients With Prostate Cancer
- Conditions
- Prostate CancerAndrogen Deprivation Therapy
- Interventions
- Behavioral: Walking football training
- Registration Number
- NCT04062162
- Lead Sponsor
- Associacao de Investigacao de Cuidados de Suporte em Oncologia
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 50
- 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.
- Medical or surgical contraindications for exercise.
- T-score < -2.5
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Interventional group Walking football training Walking football training
- Primary Outcome Measures
Name Time Method Recruitment rate. Baseline Assessed by the number of enrolled patients divided by the number of invited patients.
Withdrawal rate Change from baseline to 32 weeks Assessed by the number of withdrawal patients
Appropriateness of outcomes assessments. Change from baseline to 32 weeks Assessed by the percentage of completed data.
Adherence to intervention. Change from baseline to 32 weeks Assessed by the number of completed sessions and the number of missed sessions.
Rate of Enjoyment 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 Change from baseline to 32 weeks Using EORTC PR25, EQ-5D-5L and SF-6D questionnaire.
- Secondary Outcome Measures
Name Time Method Body composition Change from baseline to 32 weeks Assessed by a whole-body dual-energy X-ray absorptiometry (DXA) scan.
Aerobic capacity Change from baseline to 32 weeks Assessed by a symptom-limited exercise test on a treadmill
Maximal isometric handgrip strength Change from baseline to 32 weeks Assessed using a digital handgrip dynamometer.
Maximal isometric lower limb strength Change from baseline to 32 weeks Assessed using a digital handgrip dynamometer.
Exercise intensity - External load Change from baseline to 32 weeks Distance (km) assessed using GPS tracking during exercise
Bone Mineral Density Change from baseline to 32 weeks Assessed by a whole-body dual-energy X-ray absorptiometry (DXA) scan.
Lower limb functionality Change from baseline to 32 weeks Assessed by the 30-seconds sit-to-stand test
Static balance Change from baseline to 32 weeks Assessed by the single leg stance test
Habitual physical activity levels Change from baseline to 32 weeks Assessed using accelerometers
Exercise intensity - Internal load Change from baseline to 32 weeks Assessed by the heart rate
Exercise intensity - Rating of perceived exertion Change from baseline to 32 weeks Assessed using a 6-20 borg scale (minimum effort = 6; maximum effort = 10).
Cogntive function Change from baseline to 32 weeks Assessed by the Montreal Cognitive Assessment
Blood pressure Change from baseline to 32 weeks Assessed using a digital sphygmomanometer
Creatinine Change from baseline to 32 weeks Blood sample will be taken for analysis of levels of creatinine
High sensitivity C-reactive protein (HS-CRP) Change from baseline to 32 weeks Blood sample will be taken for analysis of levels of HS-CRP
Bone Specific Alkaline Phosphatase (BSAP) Change from baseline to 32 weeks Blood sample will be taken for analysis of levels of BSAP
Resting heart rate Change from baseline to 32 weeks Assessed using a digital sphygmomanometer
LDL-cholesterol Change from baseline to 32 weeks Blood sample will be taken for analysis of levels of LDL-cholesterol
Total cholesterol Change from baseline to 32 weeks Blood sample will be taken for analysis of levels of total cholesterol
N-terminal type B natriuretic peptide (NT-proBNP) Change from baseline to 32 weeks Blood sample will be taken for analysis of levels of NT-proBNP
Vitamin D Change from baseline to 32 weeks Blood sample will be taken for analysis of levels of vitamin D
Osteocalcin Change from baseline to 32 weeks Blood sample will be taken for analysis of levels of
HDL-cholesterol Change from baseline to 32 weeks Blood sample will be taken for analysis of levels of HDL-cholesterol
Triglycerides Change from baseline to 32 weeks Blood sample will be taken for analysis of levels of triglycerides
Prostate specific antigen (PSA) Change from baseline to 32 weeks Blood sample will be taken for analysis of levels of PSA
C-Telopeptide of Collagen Cross-links (CTx) Change from baseline to 32 weeks Blood sample will be taken for analysis of levels of CTx
Tartrate-Resistant Acid Phosphatase (TRAP) Change from baseline to 32 weeks Blood sample will be taken for analysis of levels of TRAP
Glycated hemoglobin Change from baseline to 32 weeks Blood sample will be taken for analysis of levels of glycated hemoglobin
Testosterone Change from baseline to 32 weeks Blood sample will be taken for analysis of levels of testosterone
Trial Locations
- Locations (1)
Centro Hospitalar Vila Nova de Gaia / Espinho
🇵🇹Vila Nova de Gaia, Portugal