Clinical trial NCT01374399: Physical Exercise Therapy vs Relaxation in Allogeneic Stem Cell Transplantation (PETRA)
Official title: Effects of an One-year Physical Exercise Intervention on Prognosis, Side-effects and Complications After Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allogeneic Stem Cell Transplantation
Keywords: allogeneic stem cell transplantation
exercise
survival
fatigue
quality of life
cancer
physical performance
Lead sponsor: German Cancer Research Center
Sponsor class: OTHER
Collaborators: name: National Center for Tumor Diseases, Heidelberg
name: University Hospital Heidelberg
name: Central Institute of Mental Health, Mannheim
First posted: 2011-06-16
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Overall survival
timeFrame: two years
Secondary outcomes:
measure: Fatigue
timeFrame: 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
measure: Quality of Life
timeFrame: 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
measure: Hemoglobin, Leukocytes, Thrombocytes
timeFrame: during hospitalisation for allo-HSCT (expected average 4-5 weeks), day 100, day 180, day 270, day 365 post transplantation
measure: Side-effects (Infections, GvHD, Depression, Distress)
timeFrame: during hospitalisation for allo-HSCT (expected average 4-5 weeks), day 100, day 180, day 270, day 365 post transplantation
measure: Adherence to exercise protocol
timeFrame: one year
measure: Muscular strength
timeFrame: 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
measure: cardiorespiratory fitness
timeFrame: 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
measure: IL-6, IL-4, IL-8, IL-10, IL-1ra, TNF-alpha, Prostaglandin
timeFrame: 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
measure: median survival, non-relapse mortality
timeFrame: admission to hospital until 2 years after transplantation
Other outcomes:
Locations:
city: Heidleberg
country: Germany
facility: German Cancer Research Center
Study officials:
affiliation: Central Institute of Mental Health
name: Martin Bohus, Prof. MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Center for Tumor Diseases
name: Joachim Wiskemann, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Heidelberg
name: Dreger Peter, Prof. MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.