Physical Exercise Training versus Relaxation in Allogeneic stem cell transplantation (PETRA Study) – Rationale and design of a randomized trial to evaluate a yearlong exercise intervention on overall survival and side-effects after allogeneic stem cell transplantation

BMC Cancer

Study Protocol

Nikolaus Kleindienst¹  Martin Bohus²  Peter Dreger³  Cornelia M. Ulrich⁴  Gerhard Huber⁵  Rea Kuehl⁶  Joachim Wiskemann⁷ 

[1] Central Institute of Mental Health, Mannheim, Germany;Central Institute of Mental Health, Mannheim, Germany;Faculty of Health, University of Antwerp, Antwerp, Belgium;Department of Medicine V, Heidelberg University, Heidelberg, Germany;Huntsman Cancer Institute, Salt Lake City, USA;Institute of Sports and Sport Science, Heidelberg University, Heidelberg, Germany;National Center for Tumor Diseases (NCT) and Heidelberg University Hospital, Heidelberg, Germany;National Center for Tumor Diseases (NCT) and German Cancer Research Center, Heidelberg, Germany;National Center for Tumor Diseases (NCT) and Heidelberg University Hospital, Heidelberg, Germany;National Center for Tumor Diseases (NCT) and German Cancer Research Center, Heidelberg, Germany;Central Institute of Mental Health, Mannheim, Germany;

关键词: Exercise Intervention;    National Comprehensive Cancer Network;    Cardiorespiratory Fitness;    Allogeneic Stem Cell Transplantation;    Karnofsky Performance Score;   

DOI  :  10.1186/s12885-015-1631-0

 received in 2015-06-15, accepted in 2015-08-28,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundAllogeneic stem cell transplantation (allo-HCT) is associated with high treatment-related mortality and innumerable physical and psychosocial complications and side-effects, such as high fatigue levels, loss of physical performance, infections, graft-versus-host disease (GvHD) and distress. This leads to a reduced quality of life, not only during and after transplantation, but also in the long term. Exercise interventions have been shown to be beneficial in allo-HCT patients. However, to date, no study has focused on long-term effects and survival. Previous exercise studies used ‘usual care’ control groups, leaving it unclear to what extent the observed effects are based on the physical effects of exercise itself, or rather on psychosocial factors such as personal attention. Furthermore, effects of exercise on and severity of GvHD have not been examined so far. We therefore aim to investigate the effects and biological mechanisms of exercise on side-effects, complications and survival in allo-HCT patients during and after transplantation.Methods/designThe PETRA study is a randomized, controlled intervention trial investigating the effects of a yearlong partly supervised mixed exercise intervention (endurance and resistance exercises, 3–5 times per week) in 256 patients during and after allogeneic stem cell transplantation. Patients in the control group perform progressive muscle relaxation training (Jacobsen method) with the same frequency. Main inclusion criterion is planned allo-HCT. Main exclusion criteria are increased fracture risk, no walking capability or severe cardiorespiratory problems. Primary endpoint is overall survival after two years; secondary endpoints are non-relapse mortality, median survival, patient reported outcomes including cancer related fatigue and quality of life, physical performance, body composition, haematological/immunological reconstitution, inflammatory parameters, severity of complications and side-effects (e.g. GvHD and infections), and cognitive capacity.DiscussionThe PETRA study will contribute to a better understanding of the physiological and psychological effects of exercise training and their biological mechanisms in cancer patients after allo-HCT. The ultimate goal is the implementation of optimized intervention programs to reduce side-effects and improve quality of life and potentially prognosis after allogeneic stem cell transplantation.Trial registrationClinicalTrials.gov Identifier: NCT01374399.

【 授权许可】

CC BY   
© Wiskemann et al. 2015