Exercise Clinical Trial
Official title:
A Randomized Controlled Clinical Trial on the Effects of Recreational Soccer Training in Men With Prostate Cancer Receiving Androgen Deprivation Therapy: The FC Prostate Study
Verified date | April 2014 |
Source | University of Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: National Board of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 57 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 75 Years |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Denmark | University of Copenhagen, Centre of Integrated Rehabilitation of Cancer Patients | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
University of Copenhagen | Beckett Foundation, Danish Cancer Society, Novo Nordisk A/S, TrygFonden, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Baseline to post intervention (12 weeks) and follow-up (32 weeks) change in Body Composition. | Changes in body composition assessed by Dual-energy X-ray absorptiometry(DXA)scan | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | No |
Secondary | Bone Mineral Density | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | No | |
Secondary | Cardiorespiratory fitness (Vo2 peak) | 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). | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | No |
Secondary | Patient reported outcomes | 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) | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | No |
Secondary | Heart function | Changes in Heart function measured by Echocardiography from baseline to post-intervention (12 weeks) and follow-up (32 weeks) | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | No |
Secondary | Glucose tolerance | Oral Glucose Tolerance Test | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | No |
Secondary | Postural Balance | Assessed standing on a force platform with feet in bilateral, unilateral and tandem position. Additionally assessed with a modified Flamingo balance test. | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | No |
Secondary | Physical function | Physical function will be assessed with sit to stand test (30s), stair climbing test and Counter Movement Jump (jump height) | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | No |
Secondary | Hip to waist ratio | Hip and waist circumference will be measured and the hip to waist ratio will be calculated | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | No |
Secondary | Muscle Strength | Muscle strength will be assessed with the 1Repetition Maximum test for knee extensors | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | No |
Secondary | Blood markers | Markers of inflammation and bone metabolism will be obtained after overnight fasting | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | No |
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