Influence of a rehabilitative exercise program on physical, psychological and psychosocial parameters in prostate cancer patients

Not Applicable

• Conditions: C61; Malignant neoplasm of prostate

• Registration Number: DRKS00004184
• Lead Sponsor: Krebsgesellschaft Nordrhein-Westfalen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2011-12-21
• Study Start: 2012-07-03
• Results First Posted: 2015-04-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 85

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is physical fitness, assessed with a spiroergometry on a treadmill at baseline, after 6 months and after in the intervention

Secondary Outcome Measures

Name	Time	Method
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.