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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00445731
First received: March 7, 2007
Last updated: September 5, 2014
Last verified: September 2014
March 7, 2007
September 5, 2014
May 2002
February 2006   (Final data collection date for primary outcome measure)
Difference in functional status as measured by Karnofsky performance scores at day 0 of allogeneic bone marrow transplantation and at day 100 post-transplantation
Same as current
Complete list of historical versions of study NCT00445731 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Structured Walking Program or Standard Therapy in Cancer Patients Undergoing a Donor Bone Marrow Transplant
A Randomized Trial of the Effect of a Walking Regimen on the Functional Status of Adult Allogeneic Donor Bone Marrow Transplant Patients

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.

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.

Interventional
Not Provided
Allocation: Randomized
Primary Purpose: Supportive Care
Cancer
  • Behavioral: exercise intervention
  • Procedure: management of therapy complications
  • Procedure: observation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
February 2006
February 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00445731
2002NT039
UMN-2002LB039
UMN-BMT-MT2002-04S
No
Not Provided
Not Provided
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Not Provided
Study Chair: Todd Defor, MS Masonic Cancer Center, University of Minnesota
University of Minnesota - Clinical and Translational Science Institute
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP