Androgen Deprivation Therapy, Exercise, Prostatic Neoplasms, Soccer Training
Conditions
Keywords
Prostatic Neoplasms, Prostate Cancer, Exercise, Soccer, Androgen Deprivation Therapy, Body Composition, Cardiovascular fitness, Bone Health, Health Related Quality of Life
Brief summary
Androgen Deprivation Therapy (ADT) is standard treatment for locally advanced or advanced Prostate Cancer (PC). The musculoskeletal toxicity associated with ADT is well established, leading to a decrease in muscle mass, increased fat percentage, weight gain, sexual dysfunction and increased risk of depression, fatigue, diabetes, cardiovascular disease and reduced quality of life. Numerous studies have shown an association between physical activity, physical capacity and quality of life in cancer patients and recent epidemiological research suggest that regular, moderate-intensity physical activity may have a positive effect on survival in men with prostate cancer. Within exercise physiology there is new evidence pointing to recreational soccer as a unique form of intermittent exercise that effectively stimulates aerobic and anaerobic energy delivery systems, leading to beneficial musculoskeletal, metabolic and cardiovascular adaptations of importance for health. It is our overall hypothesis that 12 weeks of recreational soccer training 2-3 times per week will improve the health profile of PC patients receiving ADT treatment.
Interventions
BEHAVIORALSoccer training
Sponsors
Danish Cancer Society
Novo Nordisk A/S
TrygFonden, Denmark
Beckett Foundation
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
\- Patients with locally advanced or advanced prostate cancer being treated with androgen deprivation therapy (S-testosterone \< 1.7) for at least 6 months at the time of inclusion
Exclusion criteria
* WHO performance level above 1,symptomatic cardiovascular disorders, osteoporosis (T-score below -2.5)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline to post intervention (12 weeks) and follow-up (32 weeks) change in Body Composition. | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | Changes in body composition assessed by Dual-energy X-ray absorptiometry(DXA)scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiorespiratory fitness (Vo2 peak) | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | Change in maximal oxygen consumption (Vo2 peak) assessed directly during an incremental test on a cycle ergometer from baseline to post-intervention (12 weeks) and follow-up (32 weeks). |
| Patient reported outcomes | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | Changes in Psychological distress (Hospital Anxiety and Depression Scale, HADS), Quality of Life (EORTC QLQ C-30), general well-being (SF-36), disease specific symptoms and side-effects (EORTC PR-25)from baseline to post-intervention (12 weeks) and follow-up (32 weeks) |
| Heart function | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | Changes in Heart function measured by Echocardiography from baseline to post-intervention (12 weeks) and follow-up (32 weeks) |
| Glucose tolerance | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | Oral Glucose Tolerance Test |
| Bone Mineral Density | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | — |
| Physical function | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | Physical function will be assessed with sit to stand test (30s), stair climbing test and Counter Movement Jump (jump height) |
| Hip to waist ratio | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | Hip and waist circumference will be measured and the hip to waist ratio will be calculated |
| Muscle Strength | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | Muscle strength will be assessed with the 1Repetition Maximum test for knee extensors |
| Blood markers | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | Markers of inflammation and bone metabolism will be obtained after overnight fasting |
| Postural Balance | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | Assessed standing on a force platform with feet in bilateral, unilateral and tandem position. Additionally assessed with a modified Flamingo balance test. |
Countries
Denmark
Outcome results
None listed