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Feasibility Study of Exercises for Myeloablative Allogeneic Blood and Marrow Transplantation (BMT) Patients

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ClinicalTrials.gov Identifier: NCT01396031
Recruitment Status : Unknown
Verified July 2011 by Stanford University.
Recruitment status was:  Active, not recruiting
First Posted : July 18, 2011
Last Update Posted : July 18, 2011
Sponsor:
Information provided by:

Study Description
Brief 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 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).


Condition or disease Intervention/treatment
Allogenic Disease Behavioral: Physical Therapy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Matched-Status Exercise Program in Patients Undergoing Myeloablative Allogeneic Blood and Marrow Transplantation: A Feasibility Study
Study Start Date : January 2010
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Behavioral: Physical Therapy
    Standard of care
    Other Name: physiotherapy

Outcome Measures

Primary Outcome Measures :
  1. Effect of implementing a matched-status exercise program in patients undergoing allogeneic myeloablative Blood and marrow transplantation (BMT). [ Time Frame: 100 days ]

Secondary Outcome Measures :
  1. Effect of exercise program on functional status in patients. [ Time Frame: 100 days ]
  2. Effect of exercise program on quality of life in patients. [ Time Frame: 100 days ]
  3. Effect of exercise program on fatigue in patients. [ Time Frame: 100 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01396031


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Grace Lu Stanford University
More Information

Responsible Party: Grace Lu, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01396031     History of Changes
Other Study ID Numbers: SU-05172011-7782
97821 ( Other Identifier: Stanford University Alternate IRB Approval Number )
BMTSC0002 ( Other Identifier: Stanford University )
First Posted: July 18, 2011    Key Record Dates
Last Update Posted: July 18, 2011
Last Verified: July 2011