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

NCT ID: NCT01374399

Last Updated: 2019-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Allogeneic Stem Cell Transplantation

Keywords

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allogeneic stem cell transplantation exercise survival fatigue quality of life cancer physical performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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resistance and endurance exercise

Group Type EXPERIMENTAL

exercise and relaxation

Intervention Type BEHAVIORAL

resistance and endurance exercise, 3-5 times per week

relaxation

Group Type ACTIVE_COMPARATOR

exercise and relaxation

Intervention Type BEHAVIORAL

resistance and endurance exercise, 3-5 times per week

Interventions

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exercise and relaxation

resistance and endurance exercise, 3-5 times per week

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Tumor Diseases, Heidelberg

OTHER

Sponsor Role collaborator

University Hospital Heidelberg

OTHER

Sponsor Role collaborator

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role collaborator

German Cancer Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Bohus, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Central Institute of Mental Health

Joachim Wiskemann, PhD

Role: PRINCIPAL_INVESTIGATOR

National Center for Tumor Diseases

Dreger Peter, Prof. MD

Role: STUDY_CHAIR

University Hospital Heidelberg

Locations

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German Cancer Research Center

Heidleberg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 39794666 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34152703 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26345187 (View on PubMed)

Other Identifiers

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DJCLS R 10/42pf

Identifier Type: -

Identifier Source: org_study_id