Role of Exercise in Diastolic Heart Failure

May 27, 2015 updated by: University of Michigan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • University of Michigan Mobility Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
6 minute walk
Time Frame: Baseline, 12 weeks, 24 weeks
Baseline, 12 weeks, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

January 12, 2010

First Submitted That Met QC Criteria

January 12, 2010

First Posted (Estimate)

January 13, 2010

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1997-585

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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