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

Study Overview
=================
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.

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

Conditions
-----------------
Allogeneic Stem Cell Transplantation

Intervention / Treatment
-----------------
* Behavioral: exercise and relaxation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | two years | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allogeneic stem cell transplantation, exercise, survival, fatigue, quality of life, cancer, physical performance