Androgen Deprivation Therapy, Prostate Cancer
Conditions
Keywords
Prostate Cancer, Androgen Deprivation Therapy, Walking football
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.
Interventions
BEHAVIORALWalking football training
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.
Sponsors
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
University of Beira Interior
Federação Portuguesa de Futebol
University Institute of Maia
Câmara Municipal de Gaia
Associacao de Investigacao de Cuidados de Suporte em Oncologia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 - External load | Change from baseline to 32 weeks | Distance (km) assessed using GPS tracking during exercise |
| 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 |
| 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 |
| HDL-cholesterol | Change from baseline to 32 weeks | Blood sample will be taken for analysis of levels of HDL-cholesterol |
| Total cholesterol | Change from baseline to 32 weeks | Blood sample will be taken for analysis of levels of total cholesterol |
| Bone Mineral Density | Change from baseline to 32 weeks | Assessed by a whole-body dual-energy X-ray absorptiometry (DXA) scan. |
| Prostate specific antigen (PSA) | Change from baseline to 32 weeks | Blood sample will be taken for analysis of levels of PSA |
| 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 |
| 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 |
| C-Telopeptide of Collagen Cross-links (CTx) | Change from baseline to 32 weeks | Blood sample will be taken for analysis of levels of CTx |
| Bone Specific Alkaline Phosphatase (BSAP) | Change from baseline to 32 weeks | Blood sample will be taken for analysis of levels of BSAP |
| 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 |
| Triglycerides | Change from baseline to 32 weeks | Blood sample will be taken for analysis of levels of triglycerides |
| 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. |
| Lower limb functionality | Change from baseline to 32 weeks | Assessed by the 30-seconds sit-to-stand test |
Countries
Portugal
Outcome results
None listed