A Structured Walking Program or Standard Therapy in Cancer Patients Undergoing a Donor Bone Marrow Transplant

NCT ID: NCT00445731

Last Updated: 2014-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2006-02-28

Brief Summary

RATIONALE: A walking program may improve the ability to carry out daily activities after donor bone marrow transplant.

PURPOSE: This randomized clinical trial is studying a structured walking program to see how well it works compared with standard therapy in cancer patients undergoing a donor bone marrow transplant.

Detailed Description

OBJECTIVES:

Primary

• Compare the effects of a structured walking regimen vs normal standard care on functional status at day 100 after allogeneic bone marrow transplantation in patients with cancer.

Secondary

• Compare the effects of these regimens on patient survival at day 100 and at 1 year after transplantation.
• Compare patient satisfaction with these regimens.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 intervention arms.

• Arm I: Beginning 2-3 days after allogeneic bone marrow transplantation, patients walk on a treadmill or in the hospital hallways twice daily for ≥ 15 minutes. After discharge and continuing for up to 100 days post-transplantation, patients walk once daily for ≥ 30 minutes. Patients record their walking times daily in a journal.
• Arm II: Patients receive no special instructions regarding exercise other than the normal standard of care.

All patients complete questionnaires at discharge and at day 100 post-transplantation measuring daily exercise activities, satisfaction with the recommended walking regimen, and functional status.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE

Interventions

exercise intervention

Intervention Type: BEHAVIORAL

management of therapy complications

Intervention Type: PROCEDURE

observation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following malignancies:

• Acute lymphocytic leukemia
• Chronic myelogenous leukemia
• Acute myeloid leukemia
• Hodgkin's lymphoma
• Non-Hodgkin's lymphoma
• Myelodysplastic syndromes
• Other malignancy
• Undergoing concurrent allogeneic bone marrow transplantation

PATIENT CHARACTERISTICS:

• Able to walk

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Todd Defor, MS

Role: STUDY_CHAIR

Masonic Cancer Center, University of Minnesota

Other Identifiers

UMN-2002LB039

Identifier Type: -

Identifier Source: secondary_id

UMN-BMT-MT2002-04S

Identifier Type: -

Identifier Source: secondary_id

2002NT039

Identifier Type: -

Identifier Source: org_study_id