Acute Coronary SyndromeNCT05551429
Factors Related to Participation in Cardiac Rehabilitation in Patients With Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome and Cardiovascular Diseases, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Acute coronary syndrome (ACS) is one of the most important causes of mortality and morbidity all over the world. Cardiac rehabilitation (CR) is a crucial part of secondary prevention and optimal care of patients with ACS. However, the participation rate in CR after ACS is far from expected. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome, Cardiovascular Diseases, Cardiac Rehabilitation
- What is being tested?
- Invitation to the CR
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Sep 2022to 12 Jan 2024
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-75 years admitted to the coronary intensive care unit with the diagnosis of acute coronary syndrome
Who may be able to join
- Being hospitalized in the coronary intensive care unit with the diagnosis of acute coronary syndrome
- Being able to walk and get up from a chair without the support of a person
- Agree to take part in the study
Who cannot join
- Presence of any conditions that prevent exercise training (severe orthopaedic, neurological or rheumatological disease, acute infection, acute pericarditis, endocrine and metabolic disorders, etc.)
- Presence of neuropsychiatric diseases or conditions that may prevent cooperation
- Persisting unstable angina
- Having severe stenosis or insufficiency of heart valve
- Congenital structural heart diseases
- Presence of decompensated heart failure
- Uncontrolled arrhythmias that may cause hemodynamic instability during exercise
- Exercise contraindication decision of the cardiologist
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Hospital, Department of Physical Medicine and Rehabilitation
Ankara, 06560
About this study
Official title: Factors Associated With Participation in Hospital-Based Cardiac Rehabilitation Program in Patients With Acute Coronary Syndrome
Acute coronary syndrome (ACS) is one of the most important causes of mortality and morbidity all over the world. Cardiac rehabilitation (CR) is a crucial part of secondary prevention and optimal care of patients with ACS. However, the participation rate in CR after ACS is far from expected. In our study, we will aim to examine the rate of participation in cardiac rehabilitation and the factors affecting it in patients followed up for acute coronary syndrome in the coronary intensive care unit of our hospital. Our main hypothesis is that the lower rate of participation in cardiac rehabilitation in patients with acute coronary syndrome is associated with one or more of that older age, female gender, multimorbidity, poor functional capacity, lower health literacy level or quality of life levels.
Read the detailed description
Acute coronary syndrome (ACS) is an umbrella term comprising unstable angina, myocardial infarction (MI) with or without ST-segment elevation, and sudden cardiac death because of acute myocardial ischemia. ACS is one of the most important causes of mortality and morbidity all over the world. Today, cardiac rehabilitation has become an integral part of the medical care and secondary prevention programs of cardiovascular diseases including ACS. Cardiac rehabilitation (CR) is a long-term comprehensive rehabilitation program that includes but not limited to patient evaluation, determination of risk profile, patient-tailored exercise training, and behavioural and lifestyle changes aiming at risk reduction in cooperation with many disciplines. It consists of comprehensive interventions. Despite its known benefits and recommended in national and international guidelines, the participation rate in cardiac rehabilitation is lower than expected. Studies involving different countries and societies showed that lower participation was associated with inadequate referral, female gender, poor motivation, older age, comorbidities, difficulty in transportation, and poor socioeconomic status. It has been suggested that setting up a CR appointment before discharge via clinical visits by the CR team or automatic referral systems, increasing patient interest and knowledge through written invitations and brochures, and providing support for transportation may increase participation in CR.
In our country, there are not enough studies addressing the success of participation and compliance in cardiac rehabilitation. In this study, we aim to determine patient related factors associated with low participation in CR in patients admitted to our coronary intensive care unit (ICU) with ACS diagnosis. All patients included in this study will be comprehensively informed about CR and the initial CR session will be scheduled to minimize effect of inadequate referral.
- Being tested
- Invitation to the CR
- Keywords
- Acute Coronary Syndrome, Cardiac Rehabilitation, Myocardial Infarction, Participation, Health Literacy, Rehabilitation Barriers
- Medical subject headings
- Acute Coronary Syndrome, Cardiovascular Diseases, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invitation to the CRBehavioural
- Oral and written information emphasise the benefits of cardiac rehabilitation in terms of treatment of heart diseases, increasing functional capacity, reducing morbidity and mortality, and enhancing secondary prevention.
- Introducing the scope and method of administration of CR to patients.
- Setting up the appointment for the initial CR session four weeks later.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Acute Coronary Syndrome | The study sample will comprise acute coronary syndrome patients admitted to Gazi University Faculty of Medicine, Cardiology Department, Coronary Intensive Care Unit because of one or more of the diagnoses of acute ST-elevation myocardial infarction (MI), acute non-ST elevation MI and unstable angina pectoris. Patients who are hemodynamically stable and have no signs of residual ischemia after acute care will be informed by the cardiologist about the study. After the inclusion process, patients will be evaluated in terms of clinical characteristics, muscle strength, quality of life, and health literacy. They will be given detailed information about CR and an appointment will be made four weeks later for starting the exercise program. In the follow-up, the Cardiac Rehabilitation Barriers Scale-Turkish Version will be applied to those who do not participate in the initial exercise program. Receives: Behavioral: Invitation to the CR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of participation in the CR
Number of patients admitted to the first CR session four weeks after discharge from the ICU
Measured: Four weeks after discharge from ICU
Secondary outcomes (6)
Timed Up and Go Test
It is a test that evaluates balance, mobility and lower extremity muscle strength, which includes getting up from a chair, walking 3 meters, turning back and sitting on the chair again. After an adaptation trial, the test is performed twice, including a rest period between trials. Patients are allowed to use any assistive device such as a cane or walker. The main result is the average duration of the two trials. A longer test time indicates worse performance.
Measured: At initial evaluation of the participant in ICU
Measurement of hand grip strength
Hand grip strength is an important indicator of overall muscle strength. Measurements will be performed using a Jamar dynamometer, while sitting, with the arm just next to the trunk, the elbow flexed to 90 degrees, and the forearm and wrist in a neutral position, as recommended by the American Association of Hand Therapists. Three measurements will be performed, including one-minute intervals between trials. The highest result of the three trials will be accepted.
Measured: At initial evaluation of the participant in ICU
Two minute Step Test
This test is used to evaluate the endurance of lower extremity muscles. The patient is asked to stand next to a wall. The midpoint of the distance between the patient's iliac crest and the knee is measured and marked on the wall. On the signal "go" the patient begins stepping (not running) in place, raising each knee to the mark on the wall, as many times as possible in the 2 minutes. The number of times the right knee reaches the required height is counted. If the proper knee height cannot be maintained, the patient is asked to slow down or to stop until he/she can regain the proper form, while keeping the stopwatch running.
Measured: At initial evaluation of the participant in ICU
World Health Organization Quality of Life Scale-Short Form
This scale is used for a brief assessment of the quality of life in routine clinical practice, large-scale epidemiological studies, or clinical trials. It comprises 27 questions that evaluate general health status, physical health, psychological status, social relations and environmental issues sub-titles. Each question receives an answer corresponding to 1-5 points. The percentages of the scores obtained from each sub-title allow us to make a quantitative interpretation of domains of the quality of life.
Measured: At initial evaluation of the participant in ICU
Turkish Health Literacy Scale-32
Turkish Health Literacy Scale-32 ("Türk Sağlık Okuryazarlık Ölçeği" in Turkish) is a survey comprising 32 questions that measure health literacy. It is derived from the Turkish version of The European Health Literacy Survey, which consists of 47 questions. It has been reported to be valid and reliable in Turkish population.
The survey addresses accessing, understanding, evaluating and using/applying health-related information. Each question is answered by choosing one of the options "very easy", "easy", "difficult" "very difficult" or "I don't know", corresponding to 4, 3, 2, 1 and null points, respectively. The mean score is calculated after excluding questions with invalid or "I don't know" answers. The index is determined following the formula "index = (mean score - 1) x (50/3)" A score of 0-25 indicates insufficient, >25 to 33 indicates limited, >33 to 42 indicates adequate, and >42 to 50 indicates excellent health literacy.
Measured: At initial evaluation of the participant in ICU
Cardiac Rehabilitation Barriers Scale-Turkish Version
It is a questionnaire that aims to determine the reason(s) for not attending or missing the CR sessions. Each of the 21 possible reasons is answered by the patient on a 1-5 Likert scale (strongly disagree-disagree-decided-agree-strongly disagree). The last question has an open-ended answer option for patient to report other reasons. Turkish version of this survey were found to be valid and reliable by Coşkun et al. in 2019.
Patients who do not attend to their CR appointment at fourth week after discharge will be called and the Cardiac Rehabilitation Barriers Scale-Turkish Version will be applied.
Measured: Four weeks after discharge from ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start22 Sep 2022
- Primary completion11 Dec 2023
- Study completion12 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Levent Karataş, Gazi University
- Investigators
- Nesrin Demirsoy, MD, Principal investigator, Gazi University Faculty of MedicineLevent Karataş, MD, Principal investigator, Gazi University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551429
- Sponsor's protocol ID
- Participation in Cardiac Rehab
- Status last verified
- Jan 2024
- First submitted
- 15 Sep 2022
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Price KJ, Gordon BA, Bird SR, Benson AC. A review of guidelines for cardiac rehabilitation exercise programmes: Is there an international consensus? Eur J Prev Cardiol. 2016 Nov;23(16):1715-1733. doi: 10.1177/2047487316657669. Epub 2016 Jun 27.
PubMed 27353128Pio CSA, Chaves G, Davies P, Taylor R, Grace S. Interventions to Promote Patient Utilization of Cardiac Rehabilitation: Cochrane Systematic Review and Meta-Analysis. J Clin Med. 2019 Feb 5;8(2):189. doi: 10.3390/jcm8020189.
PubMed 30764517Grace SL, Krepostman S, Brooks D, Jaglal S, Abramson BL, Scholey P, Suskin N, Arthur H, Stewart DE. Referral to and discharge from cardiac rehabilitation: key informant views on continuity of care. J Eval Clin Pract. 2006 Apr;12(2):155-63. doi: 10.1111/j.1365-2753.2006.00528.x.
PubMed 16579824Ades PA, Keteyian SJ, Wright JS, Hamm LF, Lui K, Newlin K, Shepard DS, Thomas RJ. Increasing Cardiac Rehabilitation Participation From 20% to 70%: A Road Map From the Million Hearts Cardiac Rehabilitation Collaborative. Mayo Clin Proc. 2017 Feb;92(2):234-242. doi: 10.1016/j.mayocp.2016.10.014. Epub 2016 Nov 15.
PubMed 27855953Coşkun, Özge Keniş, et al. Validity and reliability of the Turkish version of cardiac rehabilitation barriers scale. Gülhane Tip Dergisi 61.2 (2019): 59.
Okyay, P., et al. A new Health Literacy Scale: Turkish Health Literacy Scale and its psychometric properties: Pinar Okyay. The European Journal of Public Health 25.suppl_3 (2015): ckv175-220.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Participation in Hospital-Based Cardiac Rehabilitation Program in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT05551429
- Acronym / sponsor ID
- Participation in Cardiac Rehab
- Keywords
- Acute Coronary Syndrome, Cardiac Rehabilitation, Myocardial Infarction, Participation, Health Literacy, Rehabilitation Barriers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 22 Sep 2022 (actual)
- 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.
Acute coronary syndrome (ACS) is one of the most important causes of mortality and morbidity all over the world. Cardiac rehabilitation (CR) is a crucial part of secondary prevention and optimal care of patients with ACS. However, the participation rate in CR after ACS is far from expected. In our study, we will aim to examine the rate of participation in cardiac rehabilitation and the factors affecting it in patients followed up for acute coronary syndrome in the coronary intensive care unit of our hospital. Our main hypothesis is that the lower rate of participation in cardiac rehabilitation in patients with acute coronary syndrome is associated with one or more of that older age, female gender, multimorbidity, poor functional capacity, lower health literacy level or quality of life levels.
Detailed description
Acute coronary syndrome (ACS) is an umbrella term comprising unstable angina, myocardial infarction (MI) with or without ST-segment elevation, and sudden cardiac death because of acute myocardial ischemia. ACS is one of the most important causes of mortality and morbidity all over the world. Today, cardiac rehabilitation has become an integral part of the medical care and secondary prevention programs of cardiovascular diseases including ACS. Cardiac rehabilitation (CR) is a long-term comprehensive rehabilitation program that includes but not limited to patient evaluation, determination of risk profile, patient-tailored exercise training, and behavioural and lifestyle changes aiming at risk reduction in cooperation with many disciplines. It consists of comprehensive interventions. Despite its known benefits and recommended in national and international guidelines, the participation rate in cardiac rehabilitation is lower than expected. Studies involving different countries and societies showed that lower participation was associated with inadequate referral, female gender, poor motivation, older age, comorbidities, difficulty in transportation, and poor socioeconomic status. It has been suggested that setting up a CR appointment before discharge via clinical visits by the CR team or automatic referral systems, increasing patient interest and knowledge through written invitations and brochures, and providing support for transportation may increase participation in CR.
In our country, there are not enough studies addressing the success of participation and compliance in cardiac rehabilitation. In this study, we aim to determine patient related factors associated with low participation in CR in patients admitted to our coronary intensive care unit (ICU) with ACS diagnosis. All patients included in this study will be comprehensively informed about CR and the initial CR session will be scheduled to minimize effect of inadequate referral.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Acute Coronary Syndrome | – | Behavioral: Invitation to the CRThe study sample will comprise acute coronary syndrome patients admitted to Gazi University Faculty of Medicine, Cardiology Department, Coronary Intensive Care Unit because of one or more of the diagnoses of acute ST-elevation myocardial infarction (MI), acute non-ST elevation MI and unstable angina pectoris. Patients who are hemodynamically stable and have no signs of residual ischemia after acute care will be informed by the cardiologist about the study. After the inclusion process, patients will be evaluated in terms of clinical characteristics, muscle strength, quality of life, and health literacy. They will be given detailed information about CR and an appointment will be made four weeks later for starting the exercise program. In the follow-up, the Cardiac Rehabilitation Barriers Scale-Turkish Version will be applied to those who do not participate in the initial exercise program. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-75 years admitted to the coronary intensive care unit with the diagnosis of acute coronary syndrome
Key inclusion criteria (3 listed)
- Being hospitalized in the coronary intensive care unit with the diagnosis of acute coronary syndrome
- Being able to walk and get up from a chair without the support of a person
- Agree to take part in the study
Key exclusion criteria (8 listed)
- Presence of any conditions that prevent exercise training (severe orthopaedic, neurological or rheumatological disease, acute infection, acute pericarditis, endocrine and metabolic disorders, etc.)
- Presence of neuropsychiatric diseases or conditions that may prevent cooperation
- Persisting unstable angina
- Having severe stenosis or insufficiency of heart valve
- Congenital structural heart diseases
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 |
|---|---|---|
| Invitation to the CR1. Oral and written information emphasise the benefits of cardiac rehabilitation in terms of treatment of heart diseases, increasing functional capacity, reducing morbidity and mortality, and enhancing secondary prevention. 2. Introducing the scope and method of administration of CR to patients. 3. Setting up the appointment for the initial CR session four weeks later. | Behavioural | Patients with Acute Coronary Syndrome |
Primary outcome
Rate of participation in the CR
Time frame: Four weeks after discharge from ICU
Number of patients admitted to the first CR session four weeks after discharge from the ICU
6 secondary outcomes
Timed Up and Go Test
Time frame: At initial evaluation of the participant in ICU
Measurement of hand grip strength
Time frame: At initial evaluation of the participant in ICU
Two minute Step Test
Time frame: At initial evaluation of the participant in ICU
World Health Organization Quality of Life Scale-Short Form
Time frame: At initial evaluation of the participant in ICU
Turkish Health Literacy Scale-32
Time frame: At initial evaluation of the participant in ICU
Cardiac Rehabilitation Barriers Scale-Turkish Version
Time frame: Four weeks after discharge from ICU
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 22 Jan 2024.
- Background: PubMed 27353128Price KJ, Gordon BA, Bird SR, Benson AC. A review of guidelines for cardiac rehabilitation exercise programmes: Is there an international consensus? Eur J Prev Cardiol. 2016 Nov;23(16):1715-1733. doi: 10.1177/2047487316657669. Epub 2016 Jun 27.
- Background: PubMed 30764517Pio CSA, Chaves G, Davies P, Taylor R, Grace S. Interventions to Promote Patient Utilization of Cardiac Rehabilitation: Cochrane Systematic Review and Meta-Analysis. J Clin Med. 2019 Feb 5;8(2):189. doi: 10.3390/jcm8020189.
- Background: PubMed 16579824Grace SL, Krepostman S, Brooks D, Jaglal S, Abramson BL, Scholey P, Suskin N, Arthur H, Stewart DE. Referral to and discharge from cardiac rehabilitation: key informant views on continuity of care. J Eval Clin Pract. 2006 Apr;12(2):155-63. doi: 10.1111/j.1365-2753.2006.00528.x.
- Background: PubMed 27855953Ades PA, Keteyian SJ, Wright JS, Hamm LF, Lui K, Newlin K, Shepard DS, Thomas RJ. Increasing Cardiac Rehabilitation Participation From 20% to 70%: A Road Map From the Million Hearts Cardiac Rehabilitation Collaborative. Mayo Clin Proc. 2017 Feb;92(2):234-242. doi: 10.1016/j.mayocp.2016.10.014. Epub 2016 Nov 15.
- BackgroundCoşkun, Özge Keniş, et al. Validity and reliability of the Turkish version of cardiac rehabilitation barriers scale. Gülhane Tip Dergisi 61.2 (2019): 59.
- BackgroundOkyay, P., et al. A new Health Literacy Scale: Turkish Health Literacy Scale and its psychometric properties: Pinar Okyay. The European Journal of Public Health 25.suppl_3 (2015): ckv175-220.
- WHO methods and data sources for country-level causes of death 2000-2019Link provided by the sponsor.
- Turkish Health Literacy Survey (TSOY-32)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Nesrin Demirsoy, MD principal investigator
Gazi University Faculty of Medicine
Levent Karataş, MD principal investigator
Gazi University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Cardiovascular Diseases, run by Gazi University at 1 site in Turkey (Türkiye).
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 3 inclusion and 8 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 22 Jan 2024. 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 Turkey (Türkiye). 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. 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?
Rate of participation in the CR (time frame: Four weeks after discharge from ICU). 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 NCT05551429, which also lists 6 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 22 Jan 2024.