Role of Exercise in Diastolic Heart Failure

NCT01047631 | Completed

• 1 other identifier: 1997-585
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diastolic Heart Failure; Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• 6 minute walk

  Baseline, 12 weeks, 24 weeks

Study Arms (2)

Functional circuit training and lifestyle counseling

EXPERIMENTAL

Behavioral: Functional circuit training and lifestyle counseling

Health education and independent walking

ACTIVE COMPARATOR

Behavioral: Health education and independent walking

Interventions

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.

Functional circuit training and lifestyle counseling

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

Health education and independent walking

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Mobility Research Center

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 13, 2010
• Study Start: December 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: May 28, 2015

Record last verified: 2010-01

Locations

US (1)