Health Effects of Soccer Training in Men With Prostate Cancer Receiving Androgen Deprivation Therapy

Not Applicable

Completed

• Conditions: Androgen Deprivation Therapy; Prostatic Neoplasms; Exercise; Soccer Training
• Interventions: Behavioral: Soccer training

• Registration Number: NCT01711892
• Lead Sponsor: University of Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-10-17
• Study First Submitted QC: 2012-10-18
• Study First Posted: 2012-10-22
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-16
• Last Update Posted: 2014-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 57

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Soccer Training	Soccer training	12 weeks of soccer training. (2 times per week for the first 8 weeks and 3 times per week in the last 4 weeks. Training will consist of 15 minutes warm-up and 2 x 15 minutes matches for the first 4 weeks and of 15 minutes warm-up and 3 x 15 minutes matches for the last 8 weeks). After 12 weeks assessments participants in the intervention group will continue bi-weekly supervised training for additional 20 weeks at the end of which tests will be repeated.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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)
Bone Mineral Density	Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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).
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
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
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.

Trial Locations

Locations (1)

University of Copenhagen, Centre of Integrated Rehabilitation of Cancer Patients; 🇩🇰 Copenhagen, Denmark