Role of Exercise in Diastolic Heart Failure
Primary Purpose
Diastolic Heart Failure, Heart Failure With Preserved Ejection Fraction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functional circuit training and lifestyle counseling
Health education and independent walking
Sponsored by
About this trial
This is an interventional treatment trial for Diastolic Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Age 60 and over
- Evidence of diastolic dysfunction on echocardiogram
- Normal Left Ventricular Function (LVEF≥50%)
- Heart Failure-NYHA Class II/III
- Able and willing to participate in exercise program
- Able to come to Ann Arbor Michigan for testing
Exclusion Criteria:
- Regularly exercising(30 minute per day, 3 times per week)
- Orthopedic or musculoskeletal condition that limits weight bearing
- Uncontrolled atrial fibrillation
- History of heart valve replacement
- Unstable or serious medical condition (ie. on dialysis, oxygen; severe anemia, uncontrolled blood pressure or coronary artery disease)
Sites / Locations
- University of Michigan Mobility Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Functional circuit training and lifestyle counseling
Health education and independent walking
Arm Description
Outcomes
Primary Outcome Measures
6 minute walk
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01047631
Brief Title
Role of Exercise in Diastolic Heart Failure
Official Title
Relationship of Cardiovascular and Muscular Capacity to Daily Functioning in Frail Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Diastolic heart failure is now being recognized as a key form of heart failure in older people. The focus of this research is to study ways to improve and maintain physical activity and functioning. This knowledge may improve the health and well-being in people with diastolic heart failure.
Detailed Description
The purpose of this project is to better understand how endurance and fatigue relate to performing daily activities and how we might better improve endurance and reduce fatigue through an exercise program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diastolic Heart Failure, Heart Failure With Preserved Ejection Fraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Functional circuit training and lifestyle counseling
Arm Type
Experimental
Arm Title
Health education and independent walking
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Functional circuit training and lifestyle counseling
Intervention Description
Tests are performed at the beginning, and repeated after 12 and 24 weeks:
Measure general fitness levels such as walking, strength and balance.
Walk on a treadmill to measure your maximum fitness while wearing a mask to analyze your oxygen use.
Blood and urine tests and a heart ultrasound.
Questionnaires & activity measures.
Group assignment for 12 weeks:
-Exercise classes & activity guidance: Twice-weekly class that focuses on exercises that are similar to daily activities, such as walking and carrying objects. Obtain customized information and education to help you exercise and follow a low salt diet.
Follow-up:
-Monthly phone calls during the 12 week follow up period.
Intervention Type
Behavioral
Intervention Name(s)
Health education and independent walking
Intervention Description
Tests are performed at the beginning, and repeated after 12 and 24 weeks.
Measure general fitness levels such as walking, strength and balance.
Walk on a treadmill to measure your maximum fitness while wearing a mask to analyze your oxygen use.
Blood and urine tests and a heart ultrasound.
Questionnaires & activity measures.
Group assignment for 12 weeks:
-Health education and walking: Weekly health education classes covering general topics related to heart failure, like medications, diet and exercise. Receive a pedometer for an at-home walking program.
Follow-up:
-No follow up support
Primary Outcome Measure Information:
Title
6 minute walk
Time Frame
Baseline, 12 weeks, 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 60 and over
Evidence of diastolic dysfunction on echocardiogram
Normal Left Ventricular Function (LVEF≥50%)
Heart Failure-NYHA Class II/III
Able and willing to participate in exercise program
Able to come to Ann Arbor Michigan for testing
Exclusion Criteria:
Regularly exercising(30 minute per day, 3 times per week)
Orthopedic or musculoskeletal condition that limits weight bearing
Uncontrolled atrial fibrillation
History of heart valve replacement
Unstable or serious medical condition (ie. on dialysis, oxygen; severe anemia, uncontrolled blood pressure or coronary artery disease)
Facility Information:
Facility Name
University of Michigan Mobility Research Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Role of Exercise in Diastolic Heart Failure
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