Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cardiac Rehabilitation and Metabolomics in Heart Failure (CROMe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03743012
Recruitment Status : Completed
First Posted : November 15, 2018
Last Update Posted : November 27, 2019
Sponsor:
Collaborator:
Moi Teaching and Referral Hospital
Information provided by (Responsible Party):
Duke University

Brief 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.


Condition or disease Intervention/treatment Phase
Heart Failure Other: Integrated cardiac rehabilitation Other: Usual Care Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cardiac Rehabilitation Outcomes and Metabolomic Profiles Among Patients With Heart Failure in Western Kenya
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Integrated cardiac rehabilitation
Participants enrolled in integrated cardiac rehabilitation plus usual care
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.

Active Comparator: Usual Care
Participants receiving usual care only
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.




Primary Outcome Measures :
  1. 6 minute walk time distance [ Time Frame: 3 months ]
    This study seeks to find out whether 6 minute walk time distance among patients undergoing integrated cardiac rehabilitation is different when compared to usual care study participants.


Secondary Outcome Measures :
  1. Depression severity [ Time Frame: 3 months ]
    Change in total depression screening scores using PHQ9 score

  2. Quality of living [ Time Frame: 3 months ]
    Change in quality of living total score as measured by the WHO quality of life scale.


Other Outcome Measures:
  1. Metabolomic Profile [ Time Frame: 3 months ]
    This study will secondarily describe pre - post intervention changes in metabolomic profiles in participants with heart failure as measured using mass spectroscopy

  2. Inflammatory Profile [ Time Frame: 3 months ]
    This study will secondarily describe pre - post intervention changes in markers of inflammation such as hsCRP, interleukin-6, TNF-α, and ICAM-1 in participants with heart failure.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743012


Locations
Layout table for location information
Kenya
Moi teaching and Referral Hospital
Eldoret, Uasin Gishu, Kenya, 30100
Sponsors and Collaborators
Duke University
Moi Teaching and Referral Hospital
Investigators
Layout table for investigator information
Principal Investigator: Gerald Bloomfield, MD Duke University
Principal Investigator: Felix Barasa Moi Teaching and Referral Hospital
Additional Information:
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03743012    
Other Study ID Numbers: Pro00100126
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
rehabilitation
metabolomics
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases