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Novel Cardiac Rehabilitation in Patients Heart Failure and Preserved Ejection Fraction (CRpEF)

Primary Purpose

Heart Failure, Diastolic

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

HIIT

MCT

About this trial

This is an interventional treatment trial for Heart Failure, Diastolic

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

NYHA class II or III symptoms
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.
≥ 50 years of age
Free of orthopedic or other medical problems that would limit participation in CR
Peak VO2 on baseline cardiopulmonary exercise test (CPX) < 24 mL/kg/min in men and <21 mL/kg/min in women

Exclusion Criteria:

Systolic dysfunction, per ejection fraction < 50%; those with mild (grade I) diastolic dysfunction
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)
Patients with exercise induced angina during CR or CPX testing or ST segment depression representative of myocardial ischemia during CPX testing
Pregnant or planning to become pregnant
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)
Atrial fibrillation

Sites / Locations

Henry Ford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Higher Intensity Interval Training (HIIT)

Moderate Continuous Training (MCT)

Arm Description

Outcomes

Primary Outcome Measures

Change in peak oxygen consumption from baseline

Secondary Outcome Measures

Full Information

NCT ID

NCT02762825

First Posted

March 22, 2016

Last Updated

December 5, 2022

Sponsor

Henry Ford Health System

1. Study Identification

Unique Protocol Identification Number

NCT02762825

Brief Title

Novel Cardiac Rehabilitation in Patients Heart Failure and Preserved Ejection Fraction

Acronym

CRpEF

Official Title

Novel Cardiac Rehabilitation in Patients Heart Failure and Preserved Ejection Fraction

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Terminated

Why Stopped

Insufficient recruitment of eligible patients

Study Start Date

March 1, 2016 (Actual)

Primary Completion Date

September 27, 2022 (Actual)

Study Completion Date

September 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Henry Ford Health System

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Diastolic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Higher Intensity Interval Training (HIIT)

Arm Type

Experimental

Arm Title

Moderate Continuous Training (MCT)

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

HIIT

Intervention Description

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

Intervention Name(s)

MCT

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in peak oxygen consumption from baseline

Time Frame

Change from baseline at 10-12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: NYHA class II or III symptoms 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. ≥ 50 years of age Free of orthopedic or other medical problems that would limit participation in CR Peak VO2 on baseline cardiopulmonary exercise test (CPX) < 24 mL/kg/min in men and <21 mL/kg/min in women Exclusion Criteria: Systolic dysfunction, per ejection fraction < 50%; those with mild (grade I) diastolic dysfunction 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) Patients with exercise induced angina during CR or CPX testing or ST segment depression representative of myocardial ischemia during CPX testing Pregnant or planning to become pregnant 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) Atrial fibrillation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Keteyian, PhD

Organizational Affiliation

Henry Ford Health System

Official's Role

Principal Investigator

Facility Information:

Facility Name

Henry Ford Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

12. IPD Sharing Statement

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Novel Cardiac Rehabilitation in Patients Heart Failure and Preserved Ejection Fraction

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