A Structured Walking Program or Standard Therapy in Cancer Patients Undergoing a Donor Bone Marrow Transplant
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445731
|Study Chair:||Todd Defor, MS||Masonic Cancer Center, University of Minnesota|