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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00004184 |
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Date of registration:
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03/07/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Influence of a rehabilitative exercise program on physical, psychological and psychosocial parameters in prostate cancer patients
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Scientific title:
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Influence of a rehabilitative exercise program on physical, psychological and psychosocial parameters in prostate cancer patients - ProRehab Study |
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Date of first enrolment:
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13/02/2008 |
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Target sample size:
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200 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00004184 |
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Study type:
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interventional |
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Study design:
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Allocation: Non-randomized controlled study; Masking: Open (masking not used); Control: No treatment / Standard of care; Assignment: parallel; Study design purpose: supportive care
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Freerk
Baumann |
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Address:
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Am Sportpark Müngersdorf 6
50933
Köln
Germany |
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Telephone:
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0221/49824821 |
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Email:
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f.baumann@dshs-koeln.de |
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Affiliation:
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Deutsche Sporthochschule Köln
Institut für Kreislaufforschung und Sportmedizin
Abt. Molekulare und Zelluläre Sportmedizin |
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Name:
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Freerk
Baumann |
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Address:
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Am Sportpark Müngersdorf 6
50933
Köln
Germany |
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Telephone:
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0221/49824821 |
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Email:
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f.baumann@dshs-koeln.de |
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Affiliation:
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Deutsche Sporthochschule Köln
Institut für Kreislaufforschung und Sportmedizin
Abt. Molekulare und Zelluläre Sportmedizin |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with a prostate cancer disease who completed primary treatment; patients who underwent a radical prostatectomy or combination therapy (radical prostectomy + radiation); Patients who completed their primary treatment no longer than 6 to 12 weeks before the intervention begins; written consent
Exclusion criteria: severe cardiac disease (NYHA III-IV); severe mental illness or chronic disease that rules out regular physical activities; (neo-)adjuvant chemotherapy; hormone therapy; irradiation without radical prostatectomy; regular physical activities of more than 60 minutes per week; current alcohol, drug, or medication abuse; insufficient german language skills
Age minimum:
None
Age maximum:
None
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Malignant neoplasm of prostate
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C61
C61
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Intervention(s)
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Group 1: 15 month exercise program within a rehabilitative sports group
Group 2: no intervention
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Primary Outcome(s)
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The primary endpoint is physical fitness, assessed with a spiroergometry on a treadmill at baseline, after 6 months and after in the intervention
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Secondary Outcome(s)
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Secondary endpoints are urinary incontinence measured with the 20-Min. Pad-Test at three assessment time points; erectile dysfunction assessed with the IIEF questionnaire at five assessment time points; testosterone, PSA, endostatin, VEGF and IL-6 assessed by taking blood samples at three measurements; general quality of life and prostate cancer-specific quality of life assessed with the EORTC-QLQ-C30 and EORTC-QLQ-PR25 questionnaire at five assessment time points; physical activity levels (MET score) assessed with the Freiburger questionnaire of Physical Activity at five assessment time points; adherence evaluated by an adherence questionnaire at five assessment time points.
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Source(s) of Monetary Support
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Krebsgesellschaft Nordrhein-Westfalen
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Barmer GEK
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Ethics review
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Status: Approved
Approval date: 26/06/2007
Contact:
j.mangoldt@dshs-koeln.de
Ethikkommission der Deutschen Sporthochschule Köln
(+49)221-49823810
j.mangoldt@dshs-koeln.de
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