Role of Exercise in Diastolic Heart Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT01047631
First received: January 12, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted

January 12, 2010
January 12, 2010
December 2008
December 2011   (final data collection date for primary outcome measure)
6 minute walk [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Role of Exercise in Diastolic Heart Failure
Relationship of Cardiovascular and Muscular Capacity to Daily Functioning in Frail Older Adults

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diastolic Heart Failure
  • Heart Failure With Preserved Ejection Fraction
  • Behavioral: Functional circuit training and lifestyle counseling

    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.

  • Behavioral: Health education and independent walking

    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

  • Experimental: Functional circuit training and lifestyle counseling
    Intervention: Behavioral: Functional circuit training and lifestyle counseling
  • Active Comparator: Health education and independent walking
    Intervention: Behavioral: Health education and independent walking
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
March 2012
December 2011   (final data collection date for primary outcome measure)

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)
Both
60 Years and older
No
Contact: Diane Scarpace, RN, APN 734-998-7422 dianes@umich.edu
United States
 
NCT01047631
1997-585
No
Neil Alexander, MD, University of Michigan
University of Michigan
Not Provided
Not Provided
University of Michigan
January 2010

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