A Structured Walking Program or Standard Therapy in Cancer Patients Undergoing a Donor Bone Marrow Transplant
|ClinicalTrials.gov Identifier: NCT00445731|
Recruitment Status : Completed
First Posted : March 9, 2007
Last Update Posted : September 8, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Behavioral: exercise intervention Procedure: management of therapy complications Procedure: observation||Not Applicable|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized Trial of the Effect of a Walking Regimen on the Functional Status of Adult Allogeneic Donor Bone Marrow Transplant Patients|
|Study Start Date :||May 2002|
|Actual Primary Completion Date :||February 2006|
|Actual Study Completion Date :||February 2006|
- Difference in functional status as measured by Karnofsky performance scores at day 0 of allogeneic bone marrow transplantation and at day 100 post-transplantation
- Survival at day 100 and at 1 year post-transplantation
- Patient satisfaction with the suggested exercise regimen as measured by the Wilcoxon test using a 5-point rating scale
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445731
|Study Chair:||Todd Defor, MS||Masonic Cancer Center, University of Minnesota|