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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
  Purpose

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.


Condition Intervention
Diastolic Heart Failure
Heart Failure With Preserved Ejection Fraction
 Behavioral: Functional circuit training and lifestyle counseling
Behavioral: Health education and independent walking

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Relationship of Cardiovascular and Muscular Capacity to Daily Functioning in Frail Older Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 6 minute walk [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Functional circuit training and lifestyle counseling 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.
Active Comparator: Health education and independent walking 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

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047631

Contacts
Contact: Diane Scarpace, RN, APN 734-998-7422 dianes@umich.edu

Locations
United States, Michigan
University of Michigan Mobility Research Center Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Diane Scarpace, RN, APN     734-998-7422     dianes@umich.edu    
Sponsors and Collaborators
University of Michigan
  More Information

No publications provided

Responsible Party: Neil Alexander, MD, University of Michigan
ClinicalTrials.gov Identifier: NCT01047631     History of Changes
Other Study ID Numbers: 1997-585
Study First Received: January 12, 2010
Last Updated: January 12, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013