Skip to main content
OpenTrials
Completed

NCT Number: NCT01047631

Role of Exercise in Diastolic Heart Failure

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diastolic Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure With Preserved Ejection Fraction Heart Failure, Diastolic

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Mobility Research Center

Ann Arbor, Michigan, 48105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Functional circuit training and lifestyle counseling

Behavioral

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.

Health education and independent walking

Behavioral

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 outcomes

  1. 6 minute walk

    Time frame: Baseline, 12 weeks, 24 weeks

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Relationship of Cardiovascular and Muscular Capacity to Daily Functioning in Frail Older Adults

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Jan 13, 2010
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.