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

December 20, 2019 updated by: German Cancer Research Center

Effects of an One-year Physical Exercise Intervention on Prognosis, Side-effects and Complications After Allogeneic Stem Cell Transplantation

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

267

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidleberg, Germany, 69120
        • German Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: resistance and endurance exercise
Behavioral: exercise and relaxation
resistance and endurance exercise, 3-5 times per week
Active Comparator: relaxation
Behavioral: exercise and relaxation
resistance and endurance exercise, 3-5 times per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue
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
measured by the Multidimensional Fatique Inventory (MFI)
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
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
mesured by the European Organistion for Research and Treatment of Cancer questionnaire including the high dose chemotherapy module (EORTC-QLQ-C30/HDC-29)
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
Time Frame: during hospitalisation for allo-HSCT (expected average 4-5 weeks), day 100, day 180, day 270, day 365 post transplantation
Hematological and immunological reconstitution
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)
Time Frame: 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
during hospitalisation for allo-HSCT (expected average 4-5 weeks), day 100, day 180, day 270, day 365 post transplantation
Adherence to exercise protocol
Time Frame: one year
Fesability of an one-year exercise intervention after allogeneic HSCT
one year
Muscular strength
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
measured at the IsoMed2000 and/or Handheld Dynamometer
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
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
measured by ergospirometry (VO2max) and/or 6 Minutes Walk Test (meters)
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
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
Biomarker in blood and urine
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
admission to hospital until 2 years after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Cancer Research Center

Collaborators

University Hospital Heidelberg
Central Institute of Mental Health, Mannheim
National Center for Tumor Diseases, Heidelberg

Investigators

  • Principal Investigator: Joachim Wiskemann, PhD, National Center for Tumor Diseases
  • Principal Investigator: Martin Bohus, Prof. MD, Central Institute of Mental Health
  • Study Chair: Dreger Peter, Prof. MD, University Hospital Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2011

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

April 18, 2011

First Submitted That Met QC Criteria

June 15, 2011

First Posted (Estimate)

June 16, 2011

Study Record Updates

Last Update Posted (Actual)

December 24, 2019

Last Update Submitted That Met QC Criteria

December 20, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DJCLS R 10/42pf

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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