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Cardiac Rehabilitation and Metabolomics in Heart Failure

NCT03743012 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2019-11-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Integrated cardiac rehabilitation

Participants enrolled to the integrated cardiac rehabilitation arm will participate in individually tailored rehabilitation sessions that will involve aerobic activity focused on exertion at the participant's aerobic threshold (AT) over a duration of three months.

OTHER

Usual Care

Participants randomized to the usual care arm will be instructed on the benefits of exercise and continue with usual care. Participant activity will be tracked monthly using pedometers for three months of follow up.

Sponsors & Collaborators

  • Moi Teaching and Referral Hospital

    collaborator OTHER

  • Duke University

    lead OTHER

Principal Investigators

  • Gerald Bloomfield, MD · Duke University

  • Felix Barasa · Moi Teaching and Referral Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-10-31
Completion
2019-10-31

Countries

  • Kenya

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03743012 on ClinicalTrials.gov