NCT01711892

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 22, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 21, 2014

Status Verified

April 1, 2014

Enrollment Period

1.8 years

First QC Date

October 17, 2012

Last Update Submit

April 16, 2014

Conditions

Prostatic NeoplasmsExerciseSoccer TrainingAndrogen Deprivation Therapy

Keywords

Prostatic NeoplasmsProstate CancerExerciseSoccerAndrogen Deprivation TherapyBody CompositionCardiovascular fitnessBone HealthHealth Related Quality of Life

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (10)

  • 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)

  • Patient reported outcomes

    Change 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)

  • Glucose tolerance

    Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)

  • +5 more secondary outcomes

Study Arms (2)

Soccer Training

ACTIVE COMPARATOR

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.

Behavioral: Soccer training

Control group

NO INTERVENTION

Usual care

Interventions

Soccer trainingBEHAVIORAL
Soccer Training

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • WHO performance level above 1,symptomatic cardiovascular disorders, osteoporosis (T-score below -2.5)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen, Centre of Integrated Rehabilitation of Cancer Patients

Copenhagen, Copenhagen, 2100, Denmark

Location

Related Publications (6)

  • 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.

    PMID: 26620651DERIVED

  • 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.

    PMID: 26572756DERIVED

  • 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.

    PMID: 24944135DERIVED

  • 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.

    PMID: 24944134DERIVED

  • 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.

    PMID: 24944128DERIVED

  • 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.

    PMID: 24330570DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBehavior

Study Officials

  • Mikael Rørth, Professor

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project manager, Ph.d student, Master of Health Science

Study Record Dates

First Submitted

October 17, 2012

First Posted

October 22, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 21, 2014

Record last verified: 2014-04

Locations

DK(1)