Novel Cardiac Rehabilitation in Patients Heart Failure and Preserved Ejection Fraction

NCT ID: NCT02762825

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-01
• Study Completion Date: 2022-09-27

Brief Summary

Patients with HFpEF suffer from exercise intolerance, increased risk for hospitalization and mortality, and poor QOL. Unlike patients with HFrEF, no drug or device therapies appear to be consistently beneficial in treating these problems. However, increasing evidence suggests that exercise training is effective for both partially reversing exercise intolerance and improving quality of life in these patients. Most such trials to date have been conducted in controlled research setting, versus integrating these patients in to a standard CR program. Also, since functional capacity is related to outcomes in these patients, exercise strategies aimed at further improving fitness are warranted. One such strategy is using higher intensity interval training (HIIT) in the CR setting, a strategy shown to be effective in patients with other types of CVD. This project is designed to test the feasibility of incorporating these patients into the CR setting, and training them using a methodology (i.e., HIIT) already shown to yield (in other patients with CVD) greater gains in fitness when compared to what was achieved using standard MCT alone.

Conditions

Heart Failure, Diastolic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Higher Intensity Interval Training (HIIT)

Group Type: EXPERIMENTAL

HIIT

Intervention Type: BEHAVIORAL

HIIT will consist of 4 min of higher intensity work set at 90% of heart rate reserve, based on peak heart rate from CPX test. Recovery intervals will be 3-4 min in duration and set at 60-70% of heart rate reserve. Resistance training will be performed once per week.

Moderate Continuous Training (MCT)

Group Type: ACTIVE_COMPARATOR

MCT

Intervention Type: BEHAVIORAL

MCT will consist of aerobic exercise performed 3 times per week for 30 min each session, at an intensity of 60-80% of heart rate reserve, based on peak heart rate from CPX test.

Interventions

HIIT

HIIT will consist of 4 min of higher intensity work set at 90% of heart rate reserve, based on peak heart rate from CPX test. Recovery intervals will be 3-4 min in duration and set at 60-70% of heart rate reserve. Resistance training will be performed once per week.

Intervention Type: BEHAVIORAL

MCT

MCT will consist of aerobic exercise performed 3 times per week for 30 min each session, at an intensity of 60-80% of heart rate reserve, based on peak heart rate from CPX test.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. NYHA class II or III symptoms

2. Referred by physician to CR with echocardiographic evidence of HFpEF defined as an ejection fraction ≥ 50 % and moderate to severe (grade II-III) diastolic dysfunction.

3. ≥ 50 years of age

4. Free of orthopedic or other medical problems that would limit participation in CR

5. Peak VO2 on baseline cardiopulmonary exercise test (CPX) < 24 mL/kg/min in men and <21 mL/kg/min in women

Exclusion Criteria

1. Systolic dysfunction, per ejection fraction < 50%; those with mild (grade I) diastolic dysfunction

2. Initial clinical responses observed during first 3 visits in CR or baseline exercise test that would preclude participation in study over-all (e.g., new onset/troublesome arrhythmia that warrants further investigation) or undergoing HIIT (e.g., claudication, balance issue)

3. Patients with exercise induced angina during CR or CPX testing or ST segment depression representative of myocardial ischemia during CPX testing

4. Pregnant or planning to become pregnant

5. Any patient recently hospitalized for heart failure will have to wait at least 2 weeks before starting CR, or until clinically stable per physician(whichever time period is greater)

6. Atrial fibrillation

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Steven J. Keteyian

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven Keteyian, PhD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

Henry Ford Hospital

Detroit, Michigan, United States

Countries

United States

Other Identifiers

HFHS HFpEF HIIT

Identifier Type: -

Identifier Source: org_study_id