This trial is active, not recruiting.

Condition allogenic disease
Treatment physical therapy
Sponsor Stanford University
Start date January 2010
End date July 2011
Trial size 16 participants
Trial identifier NCT01396031, 97821, BMTSC0002, SU-05172011-7782


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention

Primary Outcomes

Effect of implementing a matched-status exercise program in patients undergoing allogeneic myeloablative Blood and marrow transplantation (BMT).
time frame: 100 days

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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Matched-Status Exercise Program in Patients Undergoing Myeloablative Allogeneic Blood and Marrow Transplantation: A Feasibility Study
Principal investigator Grace Lu
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Stanford University.