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

Allogeneic Stem Cell Transplantation Clinical Trial

— PETRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01374399
• Other study ID #: DJCLS R 10/42pf
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Est. completion date: July 2019

Study information

• Verified date: December 2019
• Source: German Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allogeneic Stem Cell Transplantation

Intervention

Behavioral:
• exercise and relaxation
resistance and endurance exercise, 3-5 times per week

Locations

Country	Name	City	State
Germany	German Cancer Research Center	Heidleberg

Sponsors (4)

Lead Sponsor	Collaborator
German Cancer Research Center	Central Institute of Mental Health, Mannheim, National Center for Tumor Diseases, Heidelberg, University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		two years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adherence to exercise protocol	Fesability of an one-year exercise intervention after allogeneic HSCT	one year
Secondary	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
Secondary	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
Secondary	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
Secondary	median survival, non-relapse mortality		admission to hospital until 2 years after transplantation