Allogeneic Stem Cell TransplantationPETRANCT01374399
Physical Exercise Therapy vs Relaxation in Allogeneic Stem Cell Transplantation (PETRA)
A study testing exercise and relaxation in people with Allogeneic Stem Cell Transplantation, run by German Cancer Research Center at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allogeneic Stem Cell Transplantation
- What is being tested?
- exercise and relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical indication: allogeneic stem cell transplantation
Who cannot join
- Orthopeadic limitations that hamper the exercise intervention
- Osseous degenerations that have an improved fracture risk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an One-year Physical Exercise Intervention on Prognosis, Side-effects and Complications After Allogeneic Stem Cell Transplantation
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.
- Conditions
- Allogeneic Stem Cell Transplantation
- Being tested
- exercise and relaxation
- Keywords
- allogeneic stem cell transplantation, exercise, survival, fatigue, quality of life, cancer, physical performance
- Medical subject headings
- Motor Activity, Fatigue, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise and relaxationBehavioural
resistance and endurance exercise, 3-5 times per week
| Study group | Role | What they receive |
|---|---|---|
| resistance and endurance exercise | Experimental | Not described Receives: Behavioral: exercise and relaxation |
| relaxation | Active comparator | Not described Receives: Behavioral: exercise and relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: two years
Secondary outcomes (9)
Fatigue
measured by the Multidimensional Fatique Inventory (MFI)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: one year
Muscular strength
measured at the IsoMed2000 and/or Handheld Dynamometer
Measured: 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)
Measured: 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
Measured: 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
Measured: admission to hospital until 2 years after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2011 (estimated)
- Study startFeb 2011
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Allogeneic Stem Cell TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Cancer Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Tumor Diseases, Heidelberg, University Hospital Heidelberg, Central Institute of Mental Health, Mannheim
- Responsible party
- Sponsor
- Investigators
- Martin Bohus, Prof. MD, Principal investigator, Central Institute of Mental HealthJoachim Wiskemann, PhD, Principal investigator, National Center for Tumor DiseasesDreger Peter, Prof. MD, Study chair, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374399
- Sponsor's protocol ID
- DJCLS R 10/42pf
- Acronym
- PETRA
- Status last verified
- Dec 2019
- First submitted
- 18 Apr 2011
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39794666Aziz 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.
PubMed 34152703Wiskemann 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.
PubMed 26345187
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an One-year Physical Exercise Intervention on Prognosis, Side-effects and Complications After Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01374399
- Acronym / sponsor ID
- PETRA / DJCLS R 10/42pf
- Conditions
- Allogeneic Stem Cell Transplantation
- Keywords
- allogeneic stem cell transplantation, exercise, survival, fatigue, quality of life, cancer, physical performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- German Cancer Research CenterUniversity, hospital or other
- Collaborators
- National Center for Tumor Diseases, Heidelberg, University Hospital Heidelberg, Central Institute of Mental Health, Mannheim
- Study start
- Feb 2011 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 16 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resistance and endurance exercise | Experimental | Behavioral: exercise and relaxation |
| relaxation | Active comparator | Behavioral: exercise and relaxation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Medical indication: allogeneic stem cell transplantation
Key exclusion criteria (2 listed)
- Orthopeadic limitations that hamper the exercise intervention
- Osseous degenerations that have an improved fracture risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise and relaxationresistance and endurance exercise, 3-5 times per week | Behavioural | relaxation, resistance and endurance exercise |
Primary outcome
Overall survival
Time frame: two years
9 secondary outcomes
Fatigue
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: during hospitalisation for allo-HSCT (expected average 4-5 weeks), day 100, day 180, day 270, day 365 post transplantation
Adherence to exercise protocol
Time frame: one year
Muscular strength
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: admission to hospital until 2 years after transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
- Derived from this study: PubMed 39794666Limbach 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.
- Derived from this study: PubMed 34152703Aziz 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.
- Derived from this study: PubMed 26345187Wiskemann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Bohus, Prof. MD principal investigator
Central Institute of Mental Health
Joachim Wiskemann, PhD principal investigator
National Center for Tumor Diseases
Dreger Peter, Prof. MD study chair
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise and relaxation in people with Allogeneic Stem Cell Transplantation, run by German Cancer Research Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01374399, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2019.