Role of Exercise in Diastolic Heart Failure

NCT ID: NCT01047631

Last Updated: 2015-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-03-31

Brief Summary

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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

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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.

Conditions

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Diastolic Heart Failure Heart Failure With Preserved Ejection Fraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Functional circuit training and lifestyle counseling

Group Type EXPERIMENTAL

Functional circuit training and lifestyle counseling

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Health education and independent walking

Intervention Type 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

Interventions

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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.

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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University of Michigan

Locations

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University of Michigan Mobility Research Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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1997-585

Identifier Type: -

Identifier Source: org_study_id

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