Feasibility of Cardiac Rehabilitation in Patients With Heart Failure at the Moi Teaching and Referral Hospital
FCR-HF
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable heart-failure
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2016
CompletedFirst Posted
Study publicly available on registry
June 10, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedJuly 19, 2018
July 1, 2018
1.9 years
May 31, 2016
July 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Protocol adherence
Mean adherence of at least 25% to the exercise prescriptions
12 weeks
Secondary Outcomes (4)
Change in 6 minute walk time distance (in meters)
baseline, 12 weeks
Change in Depression screen score using patient health questionnaire 9 (PHQ9)
baseline, 12 weeks
Change in Quality of life using short form health survey (SF 36) score
baseline, 12 weeks
Qualitative assessment of perceptions towards cardiac rehabilitation from focus group discussions
12 weeks
Study Arms (3)
Institutional based rehabilitation
ACTIVE COMPARATORConduct cardiac rehabilitation exercise protocol within the hospital
Home based rehabilitation
ACTIVE COMPARATORConduct cardiac rehabilitation exercise protocol at home
Observational arm
PLACEBO COMPARATORNo prescribed exercises, followed up monthly
Interventions
Perform exercise prescription for 12 weeks
Eligibility Criteria
You may qualify if:
- New York Heart Association (NYHA) Class II and III heart failure
- Have had an echocardiographic study in the past 5 years
- Owns a mobile telephone
- Can participate in exercise
- Can read/ primary care giver can read in English or Kiswahili
- Can travel to hospital three times a week
You may not qualify if:
- Recent acute illness requiring hospitalization or initiation of new medication in the preceding 4 weeks
- Limitation of activity because of factors other than fatigue or exertional dyspnea, such as arthritis, claudication in the legs, angina, advanced comorbidities
- Known arrhythmia
- Heart failure due to congenital heart disease
- Pregnant patients as may be confirmed by patient report or urine pregnancy tests
- Heart failure due to obstructive cardiomyopathy including mitral stenosis and aortic stenosis
- Presence of implanted pacemaker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Moi Teaching and Referral Hospitalcollaborator
Study Sites (1)
Moi teaching and Referral Hospital
Eldoret, Uasin Gishu County, 30100, Kenya
Related Publications (7)
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.
PMID: 24267430BACKGROUNDArroll B, Doughty R, Andersen V. Investigation and management of congestive heart failure. BMJ. 2010 Jul 14;341:c3657. doi: 10.1136/bmj.c3657. No abstract available.
PMID: 20630951BACKGROUNDKwan 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. No abstract available.
PMID: 22354982BACKGROUNDClark 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.
PMID: 23943649BACKGROUNDBinanay 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.
PMID: 26653630BACKGROUNDTurk-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.
PMID: 25027487BACKGROUNDNgeno GTK, Barasa F, Kamano J, Kwobah E, Wambui C, Binanay C, Egger JR, Kussin PS, Thielman NM, Bloomfield GS. Feasibility of Cardiac Rehabilitation Models in Kenya. Ann Glob Health. 2022 Jan 18;88(1):7. doi: 10.5334/aogh.3392. eCollection 2022.
PMID: 35087707DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerald S Bloomfield, MD
Duke Universisty
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2016
First Posted
June 10, 2016
Study Start
July 1, 2016
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
July 19, 2018
Record last verified: 2018-07