NCT01374399

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
267

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 16, 2011

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

December 24, 2019

Status Verified

December 1, 2019

Enrollment Period

8.4 years

First QC Date

April 18, 2011

Last Update Submit

December 20, 2019

Conditions

Allogeneic Stem Cell Transplantation

Keywords

allogeneic stem cell transplantationexercisesurvivalfatiguequality of lifecancerphysical performance

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    two years

Secondary Outcomes (9)

  • Fatigue

    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

    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

    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)

    during hospitalisation for allo-HSCT (expected average 4-5 weeks), day 100, day 180, day 270, day 365 post transplantation

  • Adherence to exercise protocol

    one year

  • +4 more secondary outcomes

Study Arms (2)

resistance and endurance exercise

EXPERIMENTAL
Behavioral: exercise and relaxation

relaxation

ACTIVE COMPARATOR
Behavioral: exercise and relaxation

Interventions

exercise and relaxationBEHAVIORAL

resistance and endurance exercise, 3-5 times per week

relaxationresistance and endurance exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical indication: allogeneic stem cell transplantation

You may not qualify if:

  • Orthopeadic limitations that hamper the exercise intervention
  • Osseous degenerations that have an improved fracture risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Cancer Research Center

Heidleberg, 69120, Germany

Location

Related Publications (3)

  • 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.

    PMID: 39794666DERIVED

  • 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.

    PMID: 34152703DERIVED

  • 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.

    PMID: 26345187DERIVED

MeSH Terms

Conditions

Motor ActivityFatigueNeoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2011

First Posted

June 16, 2011

Study Start

February 1, 2011

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

December 24, 2019

Record last verified: 2019-12

Locations

DE(1)