Cardiac Rehabilitation and Metabolomics in Heart Failure (CROMe)

Duke University

Status: Completed

Conditions: Heart Failure

Treatments: Other: Integrated cardiac rehabilitation; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03743012

Pro00100126

Details and patient eligibility

About

This is a randomized controlled trial of participants with heart failure randomized into usual care plus integrated cardiac rehabilitation or usual care only. The rehabilitation protocol will comprise one month of thrice weekly sessions including supervised aerobic exercises and counseling, followed by two months of monitored home based exercises prescribed weekly.

Cardiopulmonary performance status, depression and quality of life will be assessed at enrollment and upon completion of the protocol using the 6-minute walk time distance test. Plasma samples will be collected and bio-banked for metabolomic profiling and comparative outcome analysis.

Full description

Integrated cardiac rehabilitation will comprise one month of thrice weekly sessions of supervised aerobic exercises and counseling, followed by two months of monitored home based exercises prescribed weekly.

Aerobic threshold (AT) will be determined based on perceived rates of exertion as measured using a Borg scale and target heart rate based on Karvonen's formula. Exercise intensity will be prescribed to achieve the earlier of moderate perceived exertion and 50-60% of their maximal target heart rate on a treadmill. Intensity will be increased over the course of the 12 sessions to attain 70-80% of maximal target heart rate. Duration of exercise will also be increased gradually over the 12 sessions in keeping with the study participants perceived rate of exertion.

Participants will be given pedometers and instructed to use these daily for the period of the study. At the end of the first four weeks, the participant's weekly steps will be averaged to establish a baseline weekly step target. Starting in the 4th week,subjects will be instructed to continue exercises at home whilst maintaining a comparable activity level as will be measured by their weekly step counts. Participants will be contacted weekly for the remaining 8 weeks and step targets will be prescribed based on 10% weekly increments.Prior to the start of each exercise session, participants will receive a brief counseling module reflecting the primary goals of cardiac rehabilitation.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. NYHA Class II or III heart failure
2. Owns a mobile telephone
3. Can participate in supervised exercise three times a week
4. Can read/ primary care giver can read in English or Kiswahili

Exclusion criteria

1. Recent acute illness requiring hospitalization in the preceding 4 weeks.
2. Limitation of activity because of factors other than fatigue or exertional dyspnea, such as arthritis, claudication in the legs, angina, advanced co morbidities.
3. Known uncontrolled arrhythmia.
4. Heart failure due to congenital heart disease.
5. Pregnant patients as may be confirmed by patient report or urine pregnancy tests
6. Heart failure due to obstructive cardiomyopathy including mitral stenosis and aortic stenosis.
7. Use of pacemakers.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

91 participants in 2 patient groups

Integrated cardiac rehabilitation

Experimental group

Description:

Participants enrolled in integrated cardiac rehabilitation plus usual care

Treatment:

Other: Integrated cardiac rehabilitation

Usual Care

Active Comparator group

Description:

Participants receiving usual care only

Treatment:

Other: Usual Care