The PETRA-Study is a randomized, controlled trial and designed to examine the effects of an one-year physical exercise intervention on prognosis, side-effects and complications after allogeneic stem cell transplantation. The exercise intervention includes both, resistance and endurance training. Patients assigned to the control group perform a relaxation program (progressive muscle relaxation - Jacobsen) and have the same frequency of social contact.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
267
resistance and endurance exercise, 3-5 times per week
German Cancer Research Center
Heidleberg, Germany
Overall survival
Time frame: two years
Fatigue
measured by the Multidimensional Fatique Inventory (MFI)
Time frame: admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation
Quality of Life
mesured by the European Organistion for Research and Treatment of Cancer questionnaire including the high dose chemotherapy module (EORTC-QLQ-C30/HDC-29)
Time frame: admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation
Hemoglobin, Leukocytes, Thrombocytes
Hematological and immunological reconstitution
Time frame: during hospitalisation for allo-HSCT (expected average 4-5 weeks), day 100, day 180, day 270, day 365 post transplantation
Side-effects (Infections, GvHD, Depression, Distress)
Depression mesured by "Allgemeine Depressionskala" (ADS, the German version of the Center for Epidemiological Studies Depression Scale (CES-D)) Distress mesures by the NCCN Distress Thermometer
Time frame: during hospitalisation for allo-HSCT (expected average 4-5 weeks), day 100, day 180, day 270, day 365 post transplantation
Adherence to exercise protocol
Fesability of an one-year exercise intervention after allogeneic HSCT
Time frame: one year
Muscular strength
measured at the IsoMed2000 and/or Handheld Dynamometer
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Time frame: admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation
cardiorespiratory fitness
measured by ergospirometry (VO2max) and/or 6 Minutes Walk Test (meters)
Time frame: admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation
IL-6, IL-4, IL-8, IL-10, IL-1ra, TNF-alpha, Prostaglandin
Biomarker in blood and urine
Time frame: admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation
median survival, non-relapse mortality
Time frame: admission to hospital until 2 years after transplantation