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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02430792
Date of registration:	27/04/2015
Prospective Registration:	Yes
Primary sponsor:	Rigshospitalet, Denmark
Public title:	Effectiveness of Community-based Football in Prostate Cancer FC-PC
Scientific 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
Date of first enrolment:	May 2015
Target sample size:	214
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02430792
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
Phase:	N/A

Countries of recruitment
Denmark

Contacts

Name:	Julie Midtgaard, Dr
Address:
Telephone:
Email:
Affiliation:	Rigshospitalet, Denmark

Name:	Eik D Bjerre, Msc.
Address:
Telephone:
Email:
Affiliation:	Rigshospitalet, Denmark

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Behavioral: Football

Primary Outcome(s)

Mean change in quality of life from baseline to week 12 [Time Frame: 12 weeks]

Secondary Outcome(s)

Whole-body lean body mass mean change from baseline to month 6 [Time Frame: 6 months]

Femoral neck bone mineral density percent change from baseline to month 6 [Time Frame: 6 months]

Number of participants with any fracture from baseline to month 6 [Time Frame: 6 months]

Self-reported physical activity from baseline to week 12 and month 6 [Time Frame: 12 weeks and 6 months]

Mean change in quality of life from baseline to month 6 [Time Frame: 6 months]

Whole-body bone mineral content percent change from baseline to month 6 [Time Frame: 6 months]

Whole-body fat mass mean change from baseline to month 6 [Time Frame: 6 months]

Lumbar spine bone mineral density percent change from baseline to month 6 [Time Frame: 6 months]

Number of participants with falls that resulted in seeking medical assessment from baseline to month 6 [Time Frame: 6 months]

Self-reported functional well-being from baseline to week 12 and month 6 [Time Frame: 12 weeks and 6 months]

Whole-body bone mineral density percent change from baseline to month 6 [Time Frame: 6 months]

Total hip bone mineral density percent change from baseline to month 6 [Time Frame: 6 months]

Secondary ID(s)

IDnr. 106471

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Danish Cancer Society

TrygFonden, Denmark

University of Copenhagen

Parker Research Institute

The Danish Football Association

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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