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

Primary Purpose

Prostatic Neoplasms, Exercise, Soccer Training

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Soccer training
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostatic Neoplasms focused on measuring Prostatic Neoplasms, Prostate Cancer, Exercise, Soccer, Androgen Deprivation Therapy, Body Composition, Cardiovascular fitness, Bone Health, Health Related Quality of Life

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Copenhagen, Centre of Integrated Rehabilitation of Cancer Patients

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Soccer Training

Control group

Arm Description

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.

Usual care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Bone Mineral Density
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).
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)
Heart function
Changes in Heart function measured by Echocardiography from baseline to post-intervention (12 weeks) and follow-up (32 weeks)
Glucose tolerance
Oral Glucose Tolerance Test
Postural Balance
Assessed standing on a force platform with feet in bilateral, unilateral and tandem position. Additionally assessed with a modified Flamingo balance test.
Physical function
Physical function will be assessed with sit to stand test (30s), stair climbing test and Counter Movement Jump (jump height)
Hip to waist ratio
Hip and waist circumference will be measured and the hip to waist ratio will be calculated
Muscle Strength
Muscle strength will be assessed with the 1Repetition Maximum test for knee extensors
Blood markers
Markers of inflammation and bone metabolism will be obtained after overnight fasting

Full Information

First Posted
October 17, 2012
Last Updated
April 16, 2014
Sponsor
University of Copenhagen
Collaborators
Danish Cancer Society, Novo Nordisk A/S, TrygFonden, Denmark, Beckett Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01711892
Brief Title
Health Effects of Soccer Training in Men With Prostate Cancer Receiving Androgen Deprivation Therapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Danish Cancer Society, Novo Nordisk A/S, TrygFonden, Denmark, Beckett Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Exercise, Soccer Training, Androgen Deprivation Therapy
Keywords
Prostatic Neoplasms, Prostate Cancer, Exercise, Soccer, Androgen Deprivation Therapy, Body Composition, Cardiovascular fitness, Bone Health, Health Related Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Soccer Training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Soccer training
Primary Outcome Measure Information:
Title
Baseline to post intervention (12 weeks) and follow-up (32 weeks) change in Body Composition.
Description
Changes in body composition assessed by Dual-energy X-ray absorptiometry(DXA)scan
Time Frame
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Secondary Outcome Measure Information:
Title
Bone Mineral Density
Time Frame
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Title
Cardiorespiratory fitness (Vo2 peak)
Description
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).
Time Frame
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Title
Patient reported outcomes
Description
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)
Time Frame
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Title
Heart function
Description
Changes in Heart function measured by Echocardiography from baseline to post-intervention (12 weeks) and follow-up (32 weeks)
Time Frame
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Title
Glucose tolerance
Description
Oral Glucose Tolerance Test
Time Frame
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Title
Postural Balance
Description
Assessed standing on a force platform with feet in bilateral, unilateral and tandem position. Additionally assessed with a modified Flamingo balance test.
Time Frame
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Title
Physical function
Description
Physical function will be assessed with sit to stand test (30s), stair climbing test and Counter Movement Jump (jump height)
Time Frame
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Title
Hip to waist ratio
Description
Hip and waist circumference will be measured and the hip to waist ratio will be calculated
Time Frame
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Title
Muscle Strength
Description
Muscle strength will be assessed with the 1Repetition Maximum test for knee extensors
Time Frame
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Title
Blood markers
Description
Markers of inflammation and bone metabolism will be obtained after overnight fasting
Time Frame
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikael Rørth, Professor
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Copenhagen, Centre of Integrated Rehabilitation of Cancer Patients
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26620651
Citation
Uth J, Hornstrup T, Christensen JF, Christensen KB, Jorgensen NR, Helge EW, Schmidt JF, Brasso K, Helge JW, Jakobsen MD, Andersen LL, Rorth M, Midtgaard J, Krustrup P. Football training in men with prostate cancer undergoing androgen deprivation therapy: activity profile and short-term skeletal and postural balance adaptations. Eur J Appl Physiol. 2016 Mar;116(3):471-80. doi: 10.1007/s00421-015-3301-y. Epub 2015 Nov 30.
Results Reference
derived
PubMed Identifier
26572756
Citation
Uth J, Hornstrup T, Christensen JF, Christensen KB, Jorgensen NR, Schmidt JF, Brasso K, Jakobsen MD, Sundstrup E, Andersen LL, Rorth M, Midtgaard J, Krustrup P, Helge EW. Efficacy of recreational football on bone health, body composition, and physical functioning in men with prostate cancer undergoing androgen deprivation therapy: 32-week follow-up of the FC prostate randomised controlled trial. Osteoporos Int. 2016 Apr;27(4):1507-1518. doi: 10.1007/s00198-015-3399-0. Epub 2015 Nov 16.
Results Reference
derived
PubMed Identifier
24944135
Citation
Bruun DM, Krustrup P, Hornstrup T, Uth J, Brasso K, Rorth M, Christensen JF, Midtgaard J. "All boys and men can play football": a qualitative investigation of recreational football in prostate cancer patients. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:113-21. doi: 10.1111/sms.12193.
Results Reference
derived
PubMed Identifier
24944134
Citation
Uth J, Hornstrup T, Schmidt JF, Christensen JF, Frandsen C, Christensen KB, Helge EW, Brasso K, Rorth M, Midtgaard J, Krustrup P. Football training improves lean body mass in men with prostate cancer undergoing androgen deprivation therapy. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:105-12. doi: 10.1111/sms.12260.
Results Reference
derived
PubMed Identifier
24944128
Citation
Krustrup P, Hansen PR, Nielsen CM, Larsen MN, Randers MB, Manniche V, Hansen L, Dvorak J, Bangsbo J. Structural and functional cardiac adaptations to a 10-week school-based football intervention for 9-10-year-old children. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:4-9. doi: 10.1111/sms.12277.
Results Reference
derived
PubMed Identifier
24330570
Citation
Uth J, Schmidt JF, Christensen JF, Hornstrup T, Andersen LJ, Hansen PR, Christensen KB, Andersen LL, Helge EW, Brasso K, Rorth M, Krustrup P, Midtgaard J. Effects of recreational soccer in men with prostate cancer undergoing androgen deprivation therapy: study protocol for the 'FC Prostate' randomized controlled trial. BMC Cancer. 2013 Dec 13;13:595. doi: 10.1186/1471-2407-13-595.
Results Reference
derived

Learn more about this trial

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

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