Physical Exercise Therapy vs Relaxation in Allogeneic Stem Cell Transplantation (PETRA)

Not Applicable

Completed

• Conditions: Allogeneic Stem Cell Transplantation
• Interventions: Behavioral: exercise and relaxation

• Registration Number: NCT01374399
• Lead Sponsor: German Cancer Research Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-04-18
• Study First Submitted QC: 2011-06-15
• Study First Posted: 2011-06-16
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-20
• Last Update Posted: 2019-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 267

Inclusion Criteria

• Medical indication: allogeneic stem cell transplantation

Exclusion Criteria

• Orthopeadic limitations that hamper the exercise intervention
• Osseous degenerations that have an improved fracture risk

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
resistance and endurance exercise	exercise and relaxation	-
relaxation	exercise and relaxation	-

Primary Outcome Measures

Name	Time	Method
Overall survival	two years

Secondary Outcome Measures

Name	Time	Method
Adherence to exercise protocol	one year	Fesability of an one-year exercise intervention after allogeneic HSCT
Fatigue	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	measured by the Multidimensional Fatique Inventory (MFI)
Quality of Life	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	mesured by the European Organistion for Research and Treatment of Cancer questionnaire including the high dose chemotherapy module (EORTC-QLQ-C30/HDC-29)
Hemoglobin, Leukocytes, Thrombocytes	during hospitalisation for allo-HSCT (expected average 4-5 weeks), day 100, day 180, day 270, day 365 post transplantation	Hematological and immunological reconstitution
Side-effects (Infections, GvHD, Depression, Distress)	during hospitalisation for allo-HSCT (expected average 4-5 weeks), day 100, day 180, day 270, day 365 post transplantation	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
Muscular strength	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	measured at the IsoMed2000 and/or Handheld Dynamometer
cardiorespiratory fitness	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	measured by ergospirometry (VO2max) and/or 6 Minutes Walk Test (meters)
IL-6, IL-4, IL-8, IL-10, IL-1ra, TNF-alpha, Prostaglandin	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	Biomarker in blood and urine
median survival, non-relapse mortality	admission to hospital until 2 years after transplantation

Trial Locations

Locations (1)

German Cancer Research Center; 🇩🇪 Heidleberg, Germany