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Completed

NCT Number: NCT01374399

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

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.

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Key information

Conditions

Allogeneic Stem Cell Transplantation Behavior Fatigue Motor Activity Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

German Cancer Research Center

Heidleberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exercise and relaxation

Behavioral

resistance and endurance exercise, 3-5 times per week

Primary outcomes

  1. Overall survival

    Time frame: two years

Secondary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. Adherence to exercise protocol

    Time frame: one year

    Fesability of an one-year exercise intervention after allogeneic HSCT

  6. 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

  7. 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)

  8. 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

  9. median survival, non-relapse mortality

    Time frame: admission to hospital until 2 years after transplantation

Sponsors and collaborators

Lead sponsor

German Cancer Research Center

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PETRA

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Jun 16, 2011
Registry last updated
Dec 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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