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| Name | Class |
|---|---|
| National Center for Tumor Diseases, Heidelberg | OTHER |
| University Hospital Heidelberg | OTHER |
| Central Institute of Mental Health, Mannheim | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| resistance and endurance exercise | Experimental |
| |
| relaxation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise and relaxation | Behavioral | resistance and endurance exercise, 3-5 times per week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | two years |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Bohus, Prof. MD | Central Institute of Mental Health | Principal Investigator |
| Joachim Wiskemann, PhD | National Center for Tumor Diseases | Principal Investigator |
| Dreger Peter, Prof. MD | University Hospital Heidelberg | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| German Cancer Research Center | Heidleberg | 69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39794666 | Derived | Limbach M, Kuehl R, Koeppel M, Dreger P, Luft T, Bohus M, Wiskemann J. Factors affecting pretransplant muscle strength in allogeneic stem cell transplant candidates prior transplantation. Support Care Cancer. 2025 Jan 10;33(2):89. doi: 10.1007/s00520-024-09140-8. | |
| 34152703 | Derived | Aziz JA, Smith C, Slobodian M, Du I, Shorr R, De Lisio M, Allan DS. Impact of Exercise Training on Hematological Outcomes Following Hematopoietic Cell Transplantation: A Scoping Review. Clin Invest Med. 2021 Jun 14;44(2):E19-26. doi: 10.25011/cim.v44i2.36369. |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D005221 | Fatigue |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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 | 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) | 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 | Fesability of an one-year exercise intervention after allogeneic HSCT | one year |
| Muscular strength | 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 | 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 | 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 | admission to hospital until 2 years after transplantation |
| 26345187 | Derived | Wiskemann J, Kuehl R, Dreger P, Huber G, Kleindienst N, Ulrich CM, Bohus M. Physical Exercise Training versus Relaxation in Allogeneic stem cell transplantation (PETRA Study) - Rationale and design of a randomized trial to evaluate a yearlong exercise intervention on overall survival and side-effects after allogeneic stem cell transplantation. BMC Cancer. 2015 Sep 7;15:619. doi: 10.1186/s12885-015-1631-0. |