Evaluation of a supervised multi-modal physical exercise program for prostate cancer survivors in the rehabilitation phase: Rationale and study protocol of the ProCaLife study

• Published in: Contemporary clinical trials Vol. 45; no. Pt B; pp. 311 - 319
• Main Authors: Schega, Lutz, Törpel, Alexander, Hein, Nico, Napiontek, André, Wenzel, Constanze, Becker, Tim
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.11.2015
• Subjects: Aged; Behavior; Cardiovascular; Exercise; Exercise Therapy - methods; Health Behavior; Hematology, Oncology and Palliative Medicine; Humans; Male; Middle Aged; Physical activity; Physical exercise; Prostate cancer; Prostatic Neoplasms - psychology; Prostatic Neoplasms - rehabilitation; Prostatic Neoplasms - therapy; Quality of Life; Rehabilitation; Research Design; Urinary Incontinence - rehabilitation; ATS; Physical exercise; PAR-Q; Physical activity; Quality-of-Life-Questionnaire Prostate Cancer 25; control group; standardized mean difference; ADT; TNM; International Consultation on Incontinence Questionnaire; Behavior; e.g; ml; Baecke Activity Questionnaire; meter/meters; Stages of Exercise Behavior Change; body mass index; EORTC; Quality-of-Life-Questionnaire Core 30; SMD; VO 2peak; Quality of life; assessment time point 3; assessment time point 1; assessment time point 2; SEBC; gram/grams; hour/hours; MFI-20; QLQ-C30; cardiopulmonary exercise test; Rehabilitation; VT; androgen-deprivation therapy; European Organization for Research and Treatment of Cancer; ventilatory threshold; intervention group 2; CPET; RPE; km/h; kilometers per hour; malignant tumor classification system ( tumor, lymph nodes, metastasis); TTM; transtheoretical model; intervention group 1; Stages of Change; sec; ratings of perceived exertion; IG1; Multidimensional Fatigue Inventory 20; min; analysis of variance; ANOVA; IG2; kilometer/kilometers; second/seconds; International Index of Erectile Function; T1; six-minute walk test; T2; BMI; T3; ICIQ; km; IIEF; CG; milliliter/milliliters; SOC; g; h; HADS; 6MWT; for example (“exempli gratia”); m; QLQ-PR25; Physical Activity Readiness Questionnaire; American Thoracic Society; Hospital Anxiety and Depression Scale; BAQ; peak oxygen uptake; minute/minutes; Prostate cancer; VO2peak
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2015.09.020

Abstract Background After treatment for localized prostate cancer, many survivors experience severe physical and psychological/psychosocial impairments, such as urinary incontinence, erectile dysfunction, fatigue, depressive symptoms and decreased physical functioning. Physical activity and exercise can positively influence such side effects and improve quality of life. However, the majority of prostate cancer survivors are not physically active. Thus, supportive interventions, such as supervised exercise programs, are necessary. But particularly in the post-treatment phase, infrastructure and resources are limited and specific exercise recommendations for prostate cancer survivors do not yet exist. Methods/Design The ProCaLife study is a quasi-randomized controlled intervention trial evaluating a specific 26-week physical exercise program for prostate cancer survivors in the rehabilitation phase following medical treatment. Participants are assigned to one of two intervention groups (supervised multi-modal physical exercise including or not including further behavior-oriented techniques) or a control group (not receiving any supervised intervention). Exercise sessions are performed twice weekly and contain specific aerobic, strengthening, flexibility, balance, relaxation and pelvic floor/sphincter exercises as well as mixed games. Behavior-oriented techniques include physical activity-related knowledge transfer and barriers management. The primary endpoint quality of life and secondary psychological/psychosocial, urological, physical fitness and physical activity outcomes are assessed at pre-intervention, post-intervention and follow-up time points. Discussion/Conclusion By evaluating a specific supervised multi-modal physical exercise program, the ProCaLife study contributes to identify effective forms of physical exercise for prostate cancer survivors in the rehabilitation phase. This is of great importance for establishing specific exercise recommendations which are missing so far.