Hematopoetic Stem Cell TransplantationBISONNCT01575704
Physical Exercise Therapy in Pediatric Stem Cell Transplantation
A study testing Exercise and Mental Training in people with Hematopoetic Stem Cell Transplantation, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The purpose of this randomized controlled two-part study examines the effects of a structured sports intervention before, during and after hematopoetic stem cell transplantation (hsct) in children and adolescents. The main aspects in the sports groups are resistance, endurance and flexibility training. Read more about this study
- Who is it for?
- Ages 5 to 25 years
- Conditions the study is for
- Hematopoetic Stem Cell Transplantation
- What is being tested?
- Exercise and Mental Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Jun 2013
- 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 5 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Indication for hsct
- Informed consent signed
Who cannot join
- Contraindication for exercise
- Age < 5 years
- Insuperable language barrier
- Orthopeadical, cardiological or neurological indication for physical therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Exercise Therapy in Pediatric Stem Cell Transplantation (BISON- Bewegungstherapie in Der Pädiatrischen Stammzelltransplantation)
The purpose of this randomized controlled two-part study examines the effects of a structured sports intervention before, during and after hematopoetic stem cell transplantation (hsct) in children and adolescents.
The main aspects in the sports groups are resistance, endurance and flexibility training. The control group performs a mental training as well as relaxation exercises.
- Conditions
- Hematopoetic Stem Cell Transplantation
- Being tested
- Exercise, Mental Training
- Keywords
- Exercise, Hematopoetic cell transplantation, Children
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Supervised exercise training (aerobic, resistance, flexibility), 5 times per week
Mental TrainingOther
Memorial/ mental training and relaxation, 5 times per week
| Study group | Role | What they receive |
|---|---|---|
| Sport | Experimental | Not described Receives: Other: Exercise |
| Control | Other | Not described Receives: Other: Mental Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
Upper limb: hand grip strength with JAMAR dynamometry; Lower limb: maximal isometric voluntary strength of M. quadriceps femoris
Measured: change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation
Secondary outcomes (4)
Fatigue
Pediatric Quality of Life Inventory (PedsQL)
Measured: change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation
Biomarker in blood
Hematological and immunological reconstitution
Measured: daily
Body composition
Bioelectrical Impedance Analyse (BIA; Data Input GmbH)
Measured: one time per week and change between 3 months and 6 months after transplantation
Endurance performance
6-Minute-Walking-Test (6MWT); Ergospirometry and Echocardiography
Measured: change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startJan 2011
- Primary completionJan 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematopoetic 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
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institut für Sportwissenschaften, Frankfurt, Fresenius University of Applied Science
- Responsible party
- Principal investigator, Peter Bader, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575704
- Sponsor's protocol ID
- BISON01042011
- Acronym
- BISON
- Status last verified
- Mar 2015
- First submitted
- 8 Mar 2012
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Senn-Malashonak A, Wallek S, Schmidt K, Rosenhagen A, Vogt L, Bader P, Banzer W. Psychophysical effects of an exercise therapy during pediatric stem cell transplantation: a randomized controlled trial. Bone Marrow Transplant. 2019 Nov;54(11):1827-1835. doi: 10.1038/s41409-019-0535-z. Epub 2019 May 14.
PubMed 31089282
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise Therapy in Pediatric Stem Cell Transplantation (BISON- Bewegungstherapie in Der Pädiatrischen Stammzelltransplantation)
- ClinicalTrials.gov ID
- NCT01575704
- Acronym / sponsor ID
- BISON / BISON01042011
- Conditions
- Hematopoetic Stem Cell Transplantation
- Keywords
- Exercise, Hematopoetic cell transplantation, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Collaborators
- Institut für Sportwissenschaften, Frankfurt, Fresenius University of Applied Science
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 Apr 2012 (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 purpose of this randomized controlled two-part study examines the effects of a structured sports intervention before, during and after hematopoetic stem cell transplantation (hsct) in children and adolescents.
The main aspects in the sports groups are resistance, endurance and flexibility training. The control group performs a mental training as well as relaxation exercises.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sport | Experimental | Other: Exercise |
| Control | Other | Other: Mental Training |
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Indication for hsct
- Informed consent signed
Key exclusion criteria (4 listed)
- Contraindication for exercise
- Age < 5 years
- Insuperable language barrier
- Orthopeadical, cardiological or neurological indication for physical therapy
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 |
|---|---|---|
| ExerciseSupervised exercise training (aerobic, resistance, flexibility), 5 times per week | Other | Sport |
| Mental TrainingMemorial/ mental training and relaxation, 5 times per week | Other | Control |
Primary outcome
Muscle strength
Time frame: change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation
Upper limb: hand grip strength with JAMAR dynamometry; Lower limb: maximal isometric voluntary strength of M. quadriceps femoris
4 secondary outcomes
Fatigue
Time frame: change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation
Biomarker in blood
Time frame: daily
Body composition
Time frame: one time per week and change between 3 months and 6 months after transplantation
Endurance performance
Time frame: change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months 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 1 Apr 2015.
- Derived from this study: PubMed 31089282Senn-Malashonak A, Wallek S, Schmidt K, Rosenhagen A, Vogt L, Bader P, Banzer W. Psychophysical effects of an exercise therapy during pediatric stem cell transplantation: a randomized controlled trial. Bone Marrow Transplant. 2019 Nov;54(11):1827-1835. doi: 10.1038/s41409-019-0535-z. Epub 2019 May 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mental Training in people with Hematopoetic Stem Cell Transplantation, run by Johann Wolfgang Goethe University Hospital 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 2 inclusion and 4 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 1 Apr 2015. 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?
Muscle strength (time frame: change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation). 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 NCT01575704, which also lists 1 linked publication.
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 1 Apr 2015.