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Role of Exercise in Diastolic Heart Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01047631
First Posted: January 13, 2010
Last Update Posted: May 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Michigan
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 6 minute walk [ Time Frame: Baseline, 12 weeks, 24 weeks ]

Estimated Enrollment: 50
Study Start Date: December 2008
Study Completion Date: March 2012
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01047631


Locations
United States, Michigan
University of Michigan Mobility Research Center
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
University of Michigan
  More Information

Responsible Party: Neil Alexander, MD, University of Michigan
ClinicalTrials.gov Identifier: NCT01047631     History of Changes
Other Study ID Numbers: 1997-585
First Submitted: January 12, 2010
First Posted: January 13, 2010
Last Update Posted: May 28, 2015
Last Verified: January 2010

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