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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01396031
First received: July 11, 2011
Last updated: July 14, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention
Allogenic Disease
 Behavioral: Physical Therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Matched-Status Exercise Program in Patients Undergoing Myeloablative Allogeneic Blood and Marrow Transplantation: A Feasibility Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Effect of implementing a matched-status exercise program in patients undergoing allogeneic myeloablative Blood and marrow transplantation (BMT). [ Time Frame: 100 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of exercise program on functional status in patients. [ Time Frame: 100 days ] [ Designated as safety issue: No ]
  • Effect of exercise program on quality of life in patients. [ Time Frame: 100 days ] [ Designated as safety issue: No ]
  • Effect of exercise program on fatigue in patients. [ Time Frame: 100 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: January 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Physical Therapy
    Standard of care
    Other Name: physiotherapy
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Grace Lu, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01396031     History of Changes
Other Study ID Numbers: SU-05172011-7782, 97821, BMTSC0002
Study First Received: July 11, 2011
Last Updated: July 14, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013