Heart Failure Clinical Trial
Official title:
Cardiac Rehabilitation Outcomes and Metabolomic Profiles Among Patients With Heart Failure in Western Kenya
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.
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.
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