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

Cancer Clinical Trial

Official title:

A Randomized Trial of the Effect of a Walking Regimen on the Functional Status of Adult Allogeneic Donor Bone Marrow Transplant Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00445731
• Other study ID #: 2002NT039
• Secondary ID: UMN-2002LB039UMN
• Status: Completed
• Phase: N/A
• First received: March 7, 2007
• Last updated: September 5, 2014
• Start date: May 2002
• Est. completion date: February 2006

Study information

• Verified date: September 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• exercise intervention

Procedure:
• management of therapy complications

• observation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in functional status as measured by Karnofsky performance scores at day 0 of allogeneic bone marrow transplantation and at day 100 post-transplantation
Secondary	Survival at day 100 and at 1 year post-transplantation
Secondary	Patient satisfaction with the suggested exercise regimen as measured by the Wilcoxon test using a 5-point rating scale