PETRA - Study

In cooperation with the Central Institute of Mental Health (CIMH), Mannheim, the Department of Internal Medicine V (Heidelberg University Hospital) and Institute of Sports and Sports Science (Heidelberg University).

In cooperation with the Central Institute of Mental Health (CIMH), Mannheim, the Department of Internal Medicine V (Heidelberg University Hospital) and Institute of Sports and Sports Science (Heidelberg University).

The PETRA-Study is a randomized, controlled trial and designed to examine the effects of an one-year physical exercise intervention vs. relaxation therapy on side-effects, complications and prognosis after allogeneic stem cell transplantation (HSCT). Concerning the duration of the intervention (one year) the study is implemented also under feasibility aspects. The interventions start prior to HSCT and include both, resistance and endurance exercise training; the control group performs relaxation training (based on Jacobsen method). The study will include 180 (230) patients within 3 (4) years. Outcomes are clinical relevant symptoms like fatigue, quality of life, physical performance, severity of treatment related side effects (e.g. GvHD, infections, nausea), and hematological and immunological reconstruction. Furthermore, we will investigate the effect of exercise on 1-/2-year overall survival. To ensure randomized groups are similar at baseline, the randomization is stratified based on age, gender, diagnosis, remission, and conditions regimes. The assessments will be performed prior to HSCT (admission), post HSCT (discharge), day 100, day 180, day 270, and day 365 post transplantation. Standardized questionnaires are applied to assess psychological variables. To evaluate physical performance (endurance performance and muscle strength) we use an ergometer stress test (VO2 max) and the Isomed2000® for isometric and isokinetic strength. The intervention is partly supervised by an exercise therapist (inpatient setting, 5 times per week exercise, 3 times supervised) and is performed self-directed post transplantation (outpatient-setting, 3-5 times per week) until day 100 post HSCT. After day 100, the patients partly perform their exercise in a health-care center. There are weekly phone calls during the outpatient setting to enhance adherence. The control group (relaxation via audio CD) has the same frequency of social contact.

Current status
The PETRA study enrolled 159 patients till November 2013 and will be finished at the beginning of 2017.

The study is supported by the German Jose Carreas Leukemia Foundation (DJCLS R10/42pf).

Rea Kühl
Phone: +49 6221 5636180
E-mail: rea.kuehl@nct-heidelberg.de