Feasibility of Cardiac Rehabilitation in Patients With Heart Failure at the Moi Teaching and Referral Hospital (FCR-HF)

July 17, 2018 updated by: Duke University

This is a study to find out whether cardiac rehabilitation is feasible in Western Kenya.

This study will test whether cardiac rehabilitation is feasible by measuring how many participants are able to follow and complete two different exercise protocols; one at home and one in hospital. It will also measure how the exercise intervention affects quality of living, depression and improvement in exercise tolerance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cardiovascular diseases are major drivers of global disease burden. Heart failure, has a 50% mortality at 5 years and is thought to be higher in resource limited settings. Cardiac rehabilitation (CR) is a multi-disciplinary intervention which has been demonstrated to improve functional status, quality of life, and reduce morbidity and mortality in patients with heart failure. In sub-Saharan Africa, despite a significant heart failure disease burden, CR is largely non-existent. There is a compelling need for urgent development of access to CR in the region. However, feasibility and potential utilization of CR is unknown. The investigators aim to conduct a mixed methods study to evaluate feasibility of home based and institution based CR.

Participants will be voluntarily recruited from a convenience sample at the Moi Teaching and Referral Hospital (MTRH) outpatient cardiology clinic. Based on a reasonable estimate of expected subject recruitment over the time frame of study, 25 patients will be recruited into the institution based cardiac rehabilitation (IBCR) arm. In consideration of the potentially larger population and a wider geographical spread of home based cardiac rehabilitation (HBCR), 36 patients will be recruited to the HBCR arm and 40 patients will be recruited into an observational arm. While the study is not designed to make comparative outcome inferences between the HBCR and the IBCR groups, the sample size will be large enough to detect a clinically significant mean post intervention increase in 6 minute walk time distance in the HBCR arm of 50m.

The participants will be involved in physical exercises, nutritional counseling and educational sessions. Upon completion of the rehabilitation protocols, patients from both study arms will also be invited to participate in focus group discussions. Data will be analyzed and numeric data will be expressed as number (percent), means (standard deviation) or median (interquartile range). Wilcoxon rank-sum and Fisher's exact tests for pre - post intervention comparisons of continuous and binary variables, respectively. Focus group discussions will be transcribed and analyzed to identify discussion themes.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
    • Uasin Gishu
      • Eldoret, Uasin Gishu, Kenya, 30100
        • Moi Teaching and Referral Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. New York Heart Association (NYHA) Class II and III heart failure
  2. Have had an echocardiographic study in the past 5 years
  3. Owns a mobile telephone
  4. Can participate in exercise
  5. Can read/ primary care giver can read in English or Kiswahili
  6. Can travel to hospital three times a week

Exclusion Criteria:

  1. Recent acute illness requiring hospitalization or initiation of new medication 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 comorbidities
  3. Known 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. Presence of implanted pacemaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Institutional based rehabilitation
Conduct cardiac rehabilitation exercise protocol within the hospital
Procedure: Cardiac rehabilitation
Perform exercise prescription for 12 weeks
Other Names:
  • exercise
Active Comparator: Home based rehabilitation
Conduct cardiac rehabilitation exercise protocol at home
Procedure: Cardiac rehabilitation
Perform exercise prescription for 12 weeks
Other Names:
  • exercise
Placebo Comparator: Observational arm
No prescribed exercises, followed up monthly
Procedure: Cardiac rehabilitation
Perform exercise prescription for 12 weeks
Other Names:
  • exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protocol adherence
Time Frame: 12 weeks
Mean adherence of at least 25% to the exercise prescriptions
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 6 minute walk time distance (in meters)
Time Frame: baseline, 12 weeks
Measure of functional capacity
baseline, 12 weeks
Change in Depression screen score using patient health questionnaire 9 (PHQ9)
Time Frame: baseline, 12 weeks
Screen score based on patient health questionnaire 9 (PHQ9)
baseline, 12 weeks
Change in Quality of life using short form health survey (SF 36) score
Time Frame: baseline, 12 weeks
Quality of life based on short form health survey (SF 36) score
baseline, 12 weeks
Qualitative assessment of perceptions towards cardiac rehabilitation from focus group discussions
Time Frame: 12 weeks
Thematic analysis of barriers and incentives towards cardiac rehabilitation
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Moi Teaching and Referral Hospital

Investigators

  • Principal Investigator: Gerald S Bloomfield, MD, Duke Universisty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

May 31, 2016

First Submitted That Met QC Criteria

June 6, 2016

First Posted (Estimate)

June 10, 2016

Study Record Updates

Last Update Posted (Actual)

July 19, 2018

Last Update Submitted That Met QC Criteria

July 17, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00071928

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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