A Structured Walking Program or Standard Therapy in Cance... | NCT00445731 | Trialant
NCT00445731
Sponsor
University of Minnesota
Status
Completed
Last Update Posted
Sep 8, 2014Estimated
Enrollment
115Actual
Phase
Not Applicable
Conditions
Cancer
Interventions
exercise intervention
management of therapy complications
observation
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00445731
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
2002NT039
Secondary IDs
ID
Type
Description
Link
UMN-2002LB039
UMN-BMT-MT2002-04S
Brief Title
A Structured Walking Program or Standard Therapy in Cancer Patients Undergoing a Donor Bone Marrow Transplant
Official Title
A Randomized Trial of the Effect of a Walking Regimen on the Functional Status of Adult Allogeneic Donor Bone Marrow Transplant Patients
Acronym
Not provided
Organization
University of MinnesotaOTHER
Status Module
Record Verification Date
Sep 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2002
Primary Completion Date
Feb 2006Actual
Completion Date
Feb 2006Actual
First Submitted Date
Mar 7, 2007
First Submission Date that Met QC Criteria
Mar 7, 2007
First Posted Date
Mar 9, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 5, 2014
Last Update Posted Date
Sep 8, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
University of MinnesotaOTHER
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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 Module
Conditions
Cancer
Keywords
poor performance status
unspecified adult solid tumor, protocol specific
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
accelerated phase chronic myelogenous leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
atypical chronic myeloid leukemia
blastic phase chronic myelogenous leukemia
chronic eosinophilic leukemia
chronic idiopathic myelofibrosis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
115Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
exercise intervention
Behavioral
management of therapy complications
Procedure
observation
Procedure
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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 Outcomes
Measure
Description
Time Frame
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
Other Outcomes
Not provided
Eligibility Module
Eligibility 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