Back to resultsInfluence of Exercise on Anemia in MDS Patients
Primary Purpose
Feasibility Pilot Study
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Stationary Exercise cycling
Sponsored by
About this trial
This is an interventional supportive care trial for Feasibility Pilot Study
Eligibility Criteria
Inclusion Criteria:Have a confirmed diagnosis of MDS, Have approval of the study medical monitor, be able to read English, be 21 years of age or older, give informed consent -
Exclusion Criteria: Have physical limitations, be identified in the active or maintenance stage of exercise behavior
-
Sites / Locations
- James P. Wilmot Cancer Center, University of Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
Control
Exercise using stationary cycling
Arm Description
Usual care monitoring
Stationary cycling exercise program
Outcomes
Primary Outcome Measures
Feasibility data on the effect of a stationary cycling program
Aim to provide preliminary feasibility data on the effect of a stationary cycling program on anemia and acrocytosis, fatigue, aerobic capacity, strength, and hematopoietic stem and progenitor cell mitochondrial function in MDS patients.
Secondary Outcome Measures
Full Information
NCT ID
NCT01783249
First Posted
November 30, 2011
Last Updated
January 31, 2013
Sponsor
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT01783249
Brief Title
Influence of Exercise on Anemia in MDS Patients
Official Title
The Influence of Exercise on Anemia in MDS Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Withdrawn
Why Stopped
We were unable to find patients that fit the eligibility criteria.
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Rochester
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
That exercise will reduce anemia and fatigue, while improving aerobic capacity, strength and hematopoietic stem and progenitor cell mitochondrial function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feasibility Pilot Study
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care monitoring
Arm Title
Exercise using stationary cycling
Arm Type
Other
Arm Description
Stationary cycling exercise program
Intervention Type
Other
Intervention Name(s)
Stationary Exercise cycling
Intervention Description
Stationary exercise cycling
Primary Outcome Measure Information:
Title
Feasibility data on the effect of a stationary cycling program
Description
Aim to provide preliminary feasibility data on the effect of a stationary cycling program on anemia and acrocytosis, fatigue, aerobic capacity, strength, and hematopoietic stem and progenitor cell mitochondrial function in MDS patients.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Have a confirmed diagnosis of MDS, Have approval of the study medical monitor, be able to read English, be 21 years of age or older, give informed consent -
Exclusion Criteria: Have physical limitations, be identified in the active or maintenance stage of exercise behavior
-
Facility Information:
Facility Name
James P. Wilmot Cancer Center, University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
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Influence of Exercise on Anemia in MDS Patients
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