Role of Exercise in Diastolic Heart Failure

Heart Failure With Preserved Ejection Fraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047631
• Other study ID #: 1997-585
• Status: Completed
• Phase: N/A
• First received: January 12, 2010
• Last updated: May 27, 2015
• Start date: December 2008
• Est. completion date: March 2012

Study information

• Verified date: January 2010
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diastolic Heart Failure
• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Heart Failure, Diastolic

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	University of Michigan Mobility Research Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minute walk		Baseline, 12 weeks, 24 weeks	No