Allogenic DiseaseNCT01396031
Feasibility Study of Exercises for Myeloablative Allogeneic Blood and Marrow Transplantation (BMT) Patients
A study testing Physical Therapy in people with Allogenic Disease, run by Stanford University at 1 site in United States.
Trial summary
Blood and marrow transplantation (BMT) is commonly used in the treatment of oncologic and hematologic disorders. Patients undergoing Hematopoietic stem cell transplantation (HSCT) are screened for functional status among other criteria to ensure that they are able to endure the rigorous treatment involved during… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allogenic Disease
- What is being tested?
- Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jan 2011
- 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
- All diagnoses admitted for a first allogeneic myeloablative Blood and marrow transplantation (BMT)
- Adult subjects greater or equal to 18 year of age. There are no gender or ethnic restrictions
- Karnofsky performance status >= 70%.
- Admitted to E1 Day-7 (+/- 3 days).
- Patients must be informed of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Who cannot join
- Patients with musculoskeletal, neurological, cardiovascular, and pulmonary impairments will be excluded. Cardiovascular and pulmonary status will be confirmed prior to transplantation by electrocardiogram, echocardiogram, and pulmonary function tests. Musculoskeletal and screening for neurological impairments will be assessed by Karnovsky score >=70% and by Physical Therapy assessment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Matched-Status Exercise Program in Patients Undergoing Myeloablative Allogeneic Blood and Marrow Transplantation: A Feasibility Study
Blood and marrow transplantation (BMT) is commonly used in the treatment of oncologic and hematologic disorders. Patients undergoing Hematopoietic stem cell transplantation (HSCT) are screened for functional status among other criteria to ensure that they are able to endure the rigorous treatment involved during Hematopoietic stem cell transplantation (HSCT). The patient entering the transplant process is possibly already functionally compromised from their disease, prior cancer treatment, and possible other co-morbidities. Additional factors of the transplantation that compromise the independent functional status of the patient include the high dose preparative regimen, pancytopenia, steroid-related side effects, hospitalization, transplantation complications such as infections, pulmonary alterations, acute and chronic Graft-versus-host Disease (GVHD), pain, decreased nutritional input, and other sequelae of transplantation.
Physical Therapy has been utilized in this population primarily as a supportive therapy to prevent and limit the patient's functional decline. Studies have addressed general and aerobic exercise in this population but there is a paucity of research investigating the benefits of a strength-training program, particularly performed in weight-bearing, in attenuating the detrimental effects of the transplantation on functional status.
Read more
This is a feasibility study questioning if an exercise program including weight-bearing strengthening exercises and cardiovascular exercise is practical for the patients to carry out as inpatients. The study will also preliminarily determine if this exercise program influences functional outcomes and level of fatigue. Such outcome measures will include 1) FiveTimes Sit-To-Stand Test, 2) Six-Minute Walk Test, 3) stair performance, 4) Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scales.
The study population will include patients with lymphomas and acute leukemias undergoing matched-related donor allogeneic myeloablative Blood and marrow transplantation (BMT).
- Conditions
- Allogenic Disease
- Being tested
- Physical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyBehavioural
Also called physiotherapy
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Excercise | Experimental | Cardiovascular exercise Standing Hip Abduction Step-up/Step-down Wall Slide Sit-to-Stand Activity / Exercise Diary 3 times per week x ~1 month Receives: Behavioral: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of implementing a matched-status exercise program in patients undergoing allogeneic myeloablative Blood and marrow transplantation (BMT).
Measured: 100 days
Secondary outcomes (3)
Effect of exercise program on functional status in patients.
Measured: 100 days
Effect of exercise program on quality of life in patients.
Measured: 100 days
Effect of exercise program on fatigue in patients.
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2011 (estimated)
- Study startAug 2007
- Primary completionJan 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogenic DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grace Lu, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396031
- Sponsor's protocol ID
- BMTSC0002
- Other IDs
- IRB-08529, 97821, BMTSC0002
- Status last verified
- Aug 2020
- First submitted
- 11 Jul 2011
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Matched-Status Exercise Program in Patients Undergoing Myeloablative Allogeneic Blood and Marrow Transplantation: A Feasibility Study
- ClinicalTrials.gov ID
- NCT01396031
- Acronym / sponsor ID
- BMTSC0002
- Conditions
- Allogenic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 18 Jul 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.
Blood and marrow transplantation (BMT) is commonly used in the treatment of oncologic and hematologic disorders. Patients undergoing Hematopoietic stem cell transplantation (HSCT) are screened for functional status among other criteria to ensure that they are able to endure the rigorous treatment involved during Hematopoietic stem cell transplantation (HSCT). The patient entering the transplant process is possibly already functionally compromised from their disease, prior cancer treatment, and possible other co-morbidities. Additional factors of the transplantation that compromise the independent functional status of the patient include the high dose preparative regimen, pancytopenia, steroid-related side effects, hospitalization, transplantation complications such as infections, pulmonary alterations, acute and chronic Graft-versus-host Disease (GVHD), pain, decreased nutritional input, and other sequelae of transplantation.
Physical Therapy has been utilized in this population primarily as a supportive therapy to prevent and limit the patient's functional decline. Studies have addressed general and aerobic exercise in this population but there is a paucity of research investigating the benefits of a strength-training program, particularly performed in weight-bearing, in attenuating the detrimental effects of the transplantation on functional status.
This is a feasibility study questioning if an exercise program including weight-bearing strengthening exercises and cardiovascular exercise is practical for the patients to carry out as inpatients. The study will also preliminarily determine if this exercise program influences functional outcomes and level of fatigue. Such outcome measures will include 1) FiveTimes Sit-To-Stand Test, 2) Six-Minute Walk Test, 3) stair performance, 4) Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scales.
The study population will include patients with lymphomas and acute leukemias undergoing matched-related donor allogeneic myeloablative Blood and marrow transplantation (BMT).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Excercise | Experimental | Behavioral: Physical TherapyCardiovascular exercise Standing Hip Abduction Step-up/Step-down Wall Slide Sit-to-Stand Activity / Exercise Diary 3 times per week x ~1 month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All diagnoses admitted for a first allogeneic myeloablative Blood and marrow transplantation (BMT)
- Adult subjects greater or equal to 18 year of age. There are no gender or ethnic restrictions
- Karnofsky performance status >= 70%.
- Admitted to E1 Day-7 (+/- 3 days).
- Patients must be informed of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Key exclusion criteria (1 listed)
- Patients with musculoskeletal, neurological, cardiovascular, and pulmonary impairments will be excluded. Cardiovascular and pulmonary status will be confirmed prior to transplantation by electrocardiogram, echocardiogram, and pulmonary function tests. Musculoskeletal and screening for neurological impairments will be assessed by Karnovsky score >=70% and by Physical Therapy assessment.
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 |
|---|---|---|
| Physical TherapyAlso: physiotherapyStandard of care | Behavioural | Excercise |
Primary outcome
Effect of implementing a matched-status exercise program in patients undergoing allogeneic myeloablative Blood and marrow transplantation (BMT).
Time frame: 100 days
3 secondary outcomes
Effect of exercise program on functional status in patients.
Time frame: 100 days
Effect of exercise program on quality of life in patients.
Time frame: 100 days
Effect of exercise program on fatigue in patients.
Time frame: 100 days
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 Aug 2020.
Related trials for Allogenic Disease
Active, not recruitingPhase 2
De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis
Graft-versus-host Disease
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
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.
Grace Lu principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy in people with Allogenic Disease, run by Stanford University at 1 site in United States.
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 5 inclusion and 1 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 Aug 2020. 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 United States. 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?
Effect of implementing a matched-status exercise program in patients undergoing allogeneic myeloablative Blood and marrow transplantation (BMT). (time frame: 100 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2020.