Feasibility of Cardiac Rehabilitation in Patients With Heart Failure at the Moi Teaching and Referral Hospital

Heart Failure Clinical Trial

— FCR-HF  

Official title:

Feasibility of Cardiac Rehabilitation in Patients With Heart Failure at the Moi Teaching and Referral Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02795936
• Other study ID #: Pro00071928
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: June 2018

Study information

• Verified date: July 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Procedure:
• Cardiac rehabilitation
Perform exercise prescription for 12 weeks

Locations

Country	Name	City	State
Kenya	Moi teaching and Referral Hospital	Eldoret	Uasin Gishu

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Moi Teaching and Referral Hospital

Country where clinical trial is conducted

Kenya, 

References & Publications (6)

Arroll B, Doughty R, Andersen V. Investigation and management of congestive heart failure. BMJ. 2010 Jul 14;341:c3657. doi: 10.1136/bmj.c3657. Review. — View Citation

Binanay CA, Akwanalo CO, Aruasa W, Barasa FA, Corey GR, Crowe S, Esamai F, Einterz R, Foster MC, Gardner A, Kibosia J, Kimaiyo S, Koech M, Korir B, Lawrence JE, Lukas S, Manji I, Maritim P, Ogaro F, Park P, Pastakia SD, Sugut W, Vedanthan R, Yanoh R, Velazquez EJ, Bloomfield GS. Building Sustainable Capacity for Cardiovascular Care at a Public Hospital in Western Kenya. J Am Coll Cardiol. 2015 Dec 8;66(22):2550-60. doi: 10.1016/j.jacc.2015.09.086. Review. — View Citation

Clark RA, Conway A, Poulsen V, Keech W, Tirimacco R, Tideman P. Alternative models of cardiac rehabilitation: a systematic review. Eur J Prev Cardiol. 2015 Jan;22(1):35-74. doi: 10.1177/2047487313501093. Epub 2013 Aug 13. Review. — View Citation

Kwan G, Balady GJ. Cardiac rehabilitation 2012: advancing the field through emerging science. Circulation. 2012 Feb 21;125(7):e369-73. doi: 10.1161/CIRCULATIONAHA.112.093310. Review. — View Citation

Moran A, Forouzanfar M, Sampson U, Chugh S, Feigin V, Mensah G. The epidemiology of cardiovascular diseases in sub-Saharan Africa: the Global Burden of Diseases, Injuries and Risk Factors 2010 Study. Prog Cardiovasc Dis. 2013 Nov-Dec;56(3):234-9. doi: 10.1016/j.pcad.2013.09.019. Epub 2013 Sep 28. — View Citation

Turk-Adawi K, Sarrafzadegan N, Grace SL. Global availability of cardiac rehabilitation. Nat Rev Cardiol. 2014 Oct;11(10):586-96. doi: 10.1038/nrcardio.2014.98. Epub 2014 Jul 15. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protocol adherence	Mean adherence of at least 25% to the exercise prescriptions	12 weeks
Secondary	Change in 6 minute walk time distance (in meters)	Measure of functional capacity	baseline, 12 weeks
Secondary	Change in Depression screen score using patient health questionnaire 9 (PHQ9)	Screen score based on patient health questionnaire 9 (PHQ9)	baseline, 12 weeks
Secondary	Change in Quality of life using short form health survey (SF 36) score	Quality of life based on short form health survey (SF 36) score	baseline, 12 weeks
Secondary	Qualitative assessment of perceptions towards cardiac rehabilitation from focus group discussions	Thematic analysis of barriers and incentives towards cardiac rehabilitation	12 weeks

External Links

•   What is cardiac rehabilitation