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

Tracking Information

First Received Date ^ICMJE

January 12, 2010

Last Updated Date

January 12, 2010

Start Date ^ICMJE

December 2008

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Role of Exercise in Diastolic Heart Failure

Official Title ^ICMJE

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

Brief 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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Diastolic Heart Failure
Heart Failure With Preserved Ejection Fraction

Intervention ^ICMJE

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.
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

Study Arm (s)

Experimental: Functional circuit training and lifestyle counseling
Intervention: Behavioral: Functional circuit training and lifestyle counseling
Active Comparator: Health education and independent walking
Intervention: Behavioral: Health education and independent walking

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2012

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Diane Scarpace, RN, APN

734-998-7422

dianes@umich.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01047631

Other Study ID Numbers ^ICMJE

1997-585

Has Data Monitoring Committee

Responsible Party

Neil Alexander, MD, University of Michigan

Study Sponsor ^ICMJE

University of Michigan

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

University of Michigan

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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