Effectiveness of Community-based Football in Prostate Cancer (FC-PC)
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ClinicalTrials.gov Identifier: NCT02430792 |
Recruitment Status :
Completed
First Posted : April 30, 2015
Last Update Posted : March 13, 2018
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Prostate cancer is the most common malignancy in men. Three million are currently living in the United States with the disease and this number is expected to rise to four million in 2024. Most live many years with the disease and experience significant morbidity both due to disease progression and treatment toxicity. Exercise has shown to improve QoL and reduce treatment toxicity. Moreover epidemiological evidence has suggested that physical activity improves survival.
Football has been shown to induce positive effects on body composition and bone markers in a subgroup of prostate cancer patients, those receiving androgen deprivation therapy.
The objective is to examine the effectiveness of football in prostate cancer survivors.
Condition or disease | Intervention/treatment | Phase |
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Prostate Cancer | Behavioral: Football | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 214 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Supportive Care |
Official Title: | Effectiveness of Community-based Football Compared With Usual Care on Quality of Life in Men With Prostate Cancer: the FC Prostate Community Randomized Controlled Trial |
Actual Study Start Date : | May 2015 |
Actual Primary Completion Date : | September 2017 |
Actual Study Completion Date : | February 2018 |

Arm | Intervention/treatment |
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Active Comparator: Football
Recreational football 1-hour twice weekly in a local football club on a disease specific team
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Behavioral: Football
The football training will consist of sessions of 20 minutes of warm-up exercises. Followed by 20 minutes dribbling, passing, shooting exercises. Ends with 20 minutes of 5-7 a-side games. |
No Intervention: Control
A 15-30-minute guidance session upon group allocation to encourage engagement in the standard rehabilitation offered by the municipality
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- Mean change in quality of life from baseline to week 12 [ Time Frame: 12 weeks ]Assessed with Functional Assessment of Cancer Therapy - Prostate Questionaire
- Mean change in quality of life from baseline to month 6 [ Time Frame: 6 months ]Assessed with Functional Assessment of Cancer Therapy - Prostate Questionaire
- Whole-body bone mineral content percent change from baseline to month 6 [ Time Frame: 6 months ]Assessed by dual energy x-ray absorptiometry.
- Whole-body bone mineral density percent change from baseline to month 6 [ Time Frame: 6 months ]Assessed by dual energy x-ray absorptiometry.
- Whole-body lean body mass mean change from baseline to month 6 [ Time Frame: 6 months ]Assessed by dual energy x-ray absorptiometry.
- Whole-body fat mass mean change from baseline to month 6 [ Time Frame: 6 months ]Assessed by dual energy x-ray absorptiometry.
- Self-reported physical activity from baseline to week 12 and month 6 [ Time Frame: 12 weeks and 6 months ]Assessed by the International Physical Activity Questionnaire
- Self-reported functional well-being from baseline to week 12 and month 6 [ Time Frame: 12 weeks and 6 months ]Assessed with Functional Assessment of Cancer Therapy - Prostate Questionaire, subscale functional well-being
- Lumbar spine bone mineral density percent change from baseline to month 6 [ Time Frame: 6 months ]Assessed by dual energy x-ray absorptiometry.
- Femoral neck bone mineral density percent change from baseline to month 6 [ Time Frame: 6 months ]Assessed by dual energy x-ray absorptiometry.
- Total hip bone mineral density percent change from baseline to month 6 [ Time Frame: 6 months ]Assessed by dual energy x-ray absorptiometry.
- Number of participants with any fracture from baseline to month 6 [ Time Frame: 6 months ]Any fracture includes fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges
- Number of participants with falls that resulted in seeking medical assessment from baseline to month 6 [ Time Frame: 6 months ]Any falls for which participants report to obtain medical treatment
- EQ-5D-5L for use in health economics analysis [ Time Frame: 12 weeks and 6 months ]
- Medical outcomes study 12-item short-form health survey(SF-12), version 2 for use in health economics analysis [ Time Frame: 12 weeks and 6 months ]
- Dyadic adjustment [ Time Frame: 12 weeks and 6 months ]The seven-item version of the dyadic adjustment scale (DAS)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosed with prostate cancer
- Age ≥18 years
- Able to read and understand questionnaires in Danish
- Signed informed consent
Exclusion Criteria:
- <6 weeks after prostatectomy
- Football training disencouraged by primary physician
- Osteoporosis (T-score < -2,5) assessed by Dual Energy X-Ray Absorptiometry at baseline

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02430792
Denmark | |
Aarhus University Hospital | |
Aarhus, Aarhus N, Denmark, 8200 | |
Rigshospitalet | |
København, København N, Denmark, 2200 | |
Odense Universitets Hospital | |
Odense, Odense C, Denmark, 5000 | |
Sydvestjysk Sygehus, Esbjerg | |
Esbjerg, Denmark, 6700 |
Study Director: | Julie Midtgaard, Dr | Rigshospitalet, Denmark | |
Principal Investigator: | Eik D Bjerre, Msc. | Rigshospitalet, Denmark |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Eik Bjerre, Msc. PhD. Student, Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT02430792 |
Other Study ID Numbers: |
IDnr. 106471 |
First Posted: | April 30, 2015 Key Record Dates |
Last Update Posted: | March 13, 2018 |
Last Verified: | March 2018 |
Prostatic Neoplasms Exercise Football Quality of Life |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |