Heart FailureFCR-HFNCT02795936
Feasibility of Cardiac Rehabilitation in Patients With Heart Failure at the Moi Teaching and Referral Hospital
A study testing Cardiac rehabilitation in people with Heart Failure, run by Duke University at 1 site in Kenya.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cardiac rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteKenya
- Study dates
- Jul 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Kenya1 site
Moi teaching and Referral Hospital
Eldoret, Uasin Gishu County, 30100
About this study
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Cardiac rehabilitation
- Keywords
- rehabilitation, exercise
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitationProcedure or surgery
Also called exercise
Perform exercise prescription for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Institutional based rehabilitation | Active comparator | Conduct cardiac rehabilitation exercise protocol within the hospital Receives: Procedure: Cardiac rehabilitation |
| Home based rehabilitation | Active comparator | Conduct cardiac rehabilitation exercise protocol at home Receives: Procedure: Cardiac rehabilitation |
| Observational arm | Placebo comparator | No prescribed exercises, followed up monthly Receives: Procedure: Cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protocol adherence
Mean adherence of at least 25% to the exercise prescriptions
Measured: 12 weeks
Secondary outcomes (4)
Change in 6 minute walk time distance (in meters)
Measure of functional capacity
Measured: baseline, 12 weeks
Change in Depression screen score using patient health questionnaire 9 (PHQ9)
Screen score based on patient health questionnaire 9 (PHQ9)
Measured: baseline, 12 weeks
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
Measured: baseline, 12 weeks
Qualitative assessment of perceptions towards cardiac rehabilitation from focus group discussions
Thematic analysis of barriers and incentives towards cardiac rehabilitation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Moi Teaching and Referral Hospital
- Responsible party
- Sponsor
- Investigators
- Gerald S Bloomfield, MD, Principal investigator, Duke Universisty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795936
- Sponsor's protocol ID
- Pro00071928
- Acronym
- FCR-HF
- Status last verified
- Jul 2018
- First submitted
- 31 May 2016
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24267430Arroll 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.
PubMed 20630951Kwan 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.
PubMed 22354982Clark 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.
PubMed 23943649Binanay 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.
PubMed 26653630Turk-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.
PubMed 25027487Ngeno 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.
PubMed 35087707
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Cardiac Rehabilitation in Patients With Heart Failure at the Moi Teaching and Referral Hospital
- ClinicalTrials.gov ID
- NCT02795936
- Acronym / sponsor ID
- FCR-HF / Pro00071928
- Conditions
- Heart Failure
- Keywords
- rehabilitation, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Moi Teaching and Referral Hospital
- Study start
- Jul 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Institutional based rehabilitation | Active comparator | Procedure: Cardiac rehabilitationConduct cardiac rehabilitation exercise protocol within the hospital |
| Home based rehabilitation | Active comparator | Procedure: Cardiac rehabilitationConduct cardiac rehabilitation exercise protocol at home |
| Observational arm | Placebo comparator | Procedure: Cardiac rehabilitationNo prescribed exercises, followed up monthly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac rehabilitationAlso: exercisePerform exercise prescription for 12 weeks | Procedure or surgery | Home based rehabilitation, Institutional based rehabilitation, Observational arm |
Primary outcome
Protocol adherence
Time frame: 12 weeks
Mean adherence of at least 25% to the exercise prescriptions
4 secondary outcomes
Change in 6 minute walk time distance (in meters)
Time frame: baseline, 12 weeks
Change in Depression screen score using patient health questionnaire 9 (PHQ9)
Time frame: baseline, 12 weeks
Change in Quality of life using short form health survey (SF 36) score
Time frame: baseline, 12 weeks
Qualitative assessment of perceptions towards cardiac rehabilitation from focus group discussions
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Background: PubMed 24267430Moran 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.
- Background: PubMed 20630951Arroll 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.
- Background: PubMed 22354982Kwan 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.
- Background: PubMed 23943649Clark 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.
- Background: PubMed 26653630Binanay 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.
- Background: PubMed 25027487Turk-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.
- Derived from this study: PubMed 35087707Ngeno 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald S Bloomfield, MD principal investigator
Duke Universisty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac rehabilitation in people with Heart Failure, run by Duke University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protocol adherence (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02795936, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.