Myocardial InfarctionNCT04407624
Effects of Intermittent Exercise Training Programs in Patients With Myocardial Infarction
A study testing Intermittent Exercise in people with Myocardial Infarction, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
Cardiovascular diseases are a leading cause of death worldwide. According to the World Health Organization (WHO), cardiovascular diseases constitute 1/3 of all causes of death. Myocardial infarction (MI) is an irreversible myocardial necrosis due to prolonged ischemia. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Intermittent Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Oct 2019to 12 Nov 2020
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having had MI at least 3 months ago
- Stable clinical status for at least two weeks
- Walking independently
- Volunteer for research study
Who cannot join
- Having unstable angina
- Having uncontrolled hypertension
- Having hemodynamic instability
- Participating in any exercise program in the last six months
- Having a major orthopedic or neurological problem that limits functionality
Trial locations and contacts
1 site in 1 country.
Hazal Yakut, PT, MSc contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dokuz Eylül Üniversitesi School of Physical Therapy and Rehabilitation
Izmir, 35340
Elvan Keleş, PT, MSc, 00902323293535, elvan_keles@yahoo.com
Hazal Yakut, PT, MSc
About this study
Cardiovascular diseases are a leading cause of death worldwide. According to the World Health Organization (WHO), cardiovascular diseases constitute 1/3 of all causes of death.
Myocardial infarction (MI) is an irreversible myocardial necrosis due to prolonged ischemia.
Patients with MI are candidates for cardiac rehabilitation (CR). American Heart Association (AHA) guidelines recommend exercise-based cardiac rehabilitation and suggest exercise to add to patients' routine treatment. When the literature on patients with MI is examined, various exercise programs are seen. The aims of present study is investigating and comparing the effectiveness of intermittent exercise training and aerobic exercise training programs in patients with MI.
Read the detailed description
Cases are divided into two groups as exercise (control) and control group by closed envelope randomization method. All patients are informed about risk factors and risk factor management. All patients are trained 3 days in the first week under the supervision of a physiotherapist to learn individual exercise programs. Exercise programs including warm-up, loading, cooling, and relaxation exercises are shown. The warm-up period is consist of light-paced walking, active movements of several large muscle groups. During the loading period, taking into consideration the heart rate, fatigue and shortness of breath, exercises such as walking, squat, limb movements with weights, stepping on the steps, walking on different floors are shown. Stretching exercises are done during the cooling period. Intermittent loading workouts will consist of 3-minute loads and 1-minute rest intervals. Moderate aerobic exercise is consist of brisk walking to reach 60-85% of the person's maximum heart rate. Participants of the experimental group are contacted every two weeks via communication methods such as e-mail, message and telephone conversation. Exercise diary is given to all patients and is taken from them at the end of the study.
- Conditions
- Myocardial Infarction
- Being tested
- Intermittent Exercise, Control
- Keywords
- Aerobic exercise, Intermittent exercise
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent ExerciseOther
Exercise programs including warm-up, loading, cooling, and relaxation exercises are shown. The warm-up period is consist of light-paced walking, active movements of several large muscle groups. During the loading period, taking into consideration the heart rate, fatigue and shortness of breath, exercises such as walking, squat, limb movements with weights, stepping on the steps, walking on different floors are shown. Stretching exercises are done during the cooling period. Intermittent loading workouts will consist of 3-minute loads and 1-minute rest intervals. Participants are contacted every two weeks via communication methods such as e-mail, message and telephone conversation. Exercise diary is given to all patients and is taken from them at the end of the study.
ControlOther
Exercise programs including warm-up, loading, cooling, and relaxation exercises are shown. The warm-up period is consist of light-paced walking, active movements of several large muscle groups. In loading period, moderate aerobic exercise is consist of brisk walking to reach 60-85% of the person's maximum heart rate. Stretching exercises are done during the cooling period.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Exercise Group | Experimental | Warm-up, loading (walking, squat, sitting down on a chair, limb movements with weights, stepping on steps, walking on different floors), cooling and relaxation exercises Receives: Other: Intermittent Exercise |
| Control Group | Active comparator | Warm-up, loading (brisk walking at 60-85% of maximum heart rate), cooling and relaxation exercises Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional capacity
Six-minute walk test (6MWT) is a valid, reliable and useful test for assessing functional capacity of patients. This test assesses distance walked over 6 minutes as a sub maximal test of aerobic capacity/endurance.
Measured: Baseline, 12th week
Change in peripheral muscle strength
The Jamar Handgrip Dynamometer is an instrument for measuring the maximum isometric strength of the hand and forearm muscles.
Quadriceps isometric muscle strength is measured with a Hand Held Dynamometer.
Measured: Baseline, 12th week
Change in respiratory muscle strength
Measurement of respiratory muscle strength is useful in order to detect respiratory muscle weakness and to quantify its severity. Respiratory muscle strength is assessed by mouth pressures sustained for 1 s during maximal static manoeuvre against a closed shutter.
Measured: Baseline, 12th week
Change in FEV1
FEV1 is the maximal amount of air which is forcefully exhale in one second. It is then converted to a percentage of normal predicted based on height, weight, and race.
Measured: Baseline, 12th week
Change in FVC
Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from lungs after taking the deepest breath possible, as measured by spirometry.
Measured: Baseline, 12th week
Change in FEV1/FVC
Also known as Tiffeneau-Pinelli index, FEV1/FVC ratio is often used in diagnosing and treating lung diseases. The FEV1/FVC ratio is a measurement of the amount of air you can forcefully exhale from your lungs.
Measured: Baseline, 12th week
Change in PEF
Peak expiratory flow (PEF) is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration, measured in liters per minute or in liters per second.
Measured: Baseline, 12th week
Secondary outcomes (10)
Change in weight
Tanita Body Composition Analyzer determines body weight as kilograms (kg).
Measured: Baseline, 12th week
Change in body mass index
Tanita Body Composition Analyzer determines Body Mass Index (BMI) which is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.
Measured: Baseline, 12th week
Change in body fat percentage
Tanita Body Composition Analyzer determines the body fat percentage (BFP) which is the total mass of fat divided by total body mass, multiplied by 100.
Measured: Baseline, 12th week
Change in lean body mass
Tanita Body Composition Analyzer determines Lean Body Mass (LBM) also known as "Fat-Free Mass" which is the total weight of body minus all the weight due to your fat mass. LBM includes the weight of organs, skin, bones, body water and muscle mass.
Measured: Baseline, 12th week
Change in severity of dyspnoea
Modified Medical Research Council (mMRC) dyspnea scale is a valid and reliable test for measuring the severity of dyspnea. This scale ranges from 0 to 4. A higher value represents a worse outcome.
Measured: Baseline, 12th week
Change in The Tampa Kinesiophobia Scale for Heart Patients
The Tampa Kinesiophobia Scale for Heart Patients is a questionnaire consisting of 17 questions evaluating the fear of movement in heart patients. The minimum value is 17 and the maximum value is 68, and the higher score means a worse outcome.
Measured: Baseline, 12th week
Change in The International Physical Activity Questionnaire-short form
The International Physical Activity Questionnaire-short form (IPAQ-SF) consists of 7 questions and gives information about the time spent on walking, moderate-to-severe, severe activities. A score in MET-minutes is obtained. The minimum value is 0 and the higher score means a better outcome.
Measured: Baseline, 12th week
Change in The Fatigue Severity Scale
The Fatigue Severity Scale (FSS) is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. The minimum value is 9 and the maximum value is 63. The higher score means greater fatigue severity.
Measured: Baseline, 12th week
Change in The Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) assesses both anxiety and depression, which commonly coexist. It comprises seven questions for anxiety and seven questions for depression, and takes 2-5 min to complete. The minimum value is 0, the maximum value is 21 and the higher score means a worse outcome.
Measured: Baseline, 12th week
Change in MacNew Heart Disease Health-Related Quality of Life instrument
The MacNew Heart Disease Health-related Quality of Life (HRQL) instrument is designed to assess patient's feelings about how ischemic heart disease affects daily functioning and contains 27 items with a global HRQL score and physical limitation and emotional, and social function subscales with a 2-week timeframe. The maximum possible score in any domain is 7 and the minimum is 1. The higher score means a better outcome.
Measured: Baseline, 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start9 Oct 2019
- Primary completion10 Jun 2020 (estimated)
- Study completion12 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elvan Keles, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407624
- Sponsor's protocol ID
- 4923-GOA
- Status last verified
- May 2020
- First submitted
- 27 Jan 2020
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yakut H, Dursun H, Felekoglu E, Baskurt AA, Alpaydin AO, Ozalevli S. Effect of home-based high-intensity interval training versus moderate-intensity continuous training in patients with myocardial infarction: a randomized controlled trial. Ir J Med Sci. 2022 Dec;191(6):2539-2548. doi: 10.1007/s11845-021-02867-x. Epub 2022 Jan 7.
PubMed 34993836Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.
PubMed 34741536
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intermittent Exercise Training Programs in Patients With Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04407624
- Acronym / sponsor ID
- 4923-GOA
- Conditions
- Myocardial Infarction
- Keywords
- Aerobic exercise, Intermittent exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 10 Jun 2020 (estimated)
- Study completion
- 12 Nov 2020 (estimated)
- First posted
- 29 May 2020 (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.
Cardiovascular diseases are a leading cause of death worldwide. According to the World Health Organization (WHO), cardiovascular diseases constitute 1/3 of all causes of death.
Myocardial infarction (MI) is an irreversible myocardial necrosis due to prolonged ischemia.
Patients with MI are candidates for cardiac rehabilitation (CR). American Heart Association (AHA) guidelines recommend exercise-based cardiac rehabilitation and suggest exercise to add to patients' routine treatment. When the literature on patients with MI is examined, various exercise programs are seen. The aims of present study is investigating and comparing the effectiveness of intermittent exercise training and aerobic exercise training programs in patients with MI.
Detailed description
Cases are divided into two groups as exercise (control) and control group by closed envelope randomization method. All patients are informed about risk factors and risk factor management. All patients are trained 3 days in the first week under the supervision of a physiotherapist to learn individual exercise programs. Exercise programs including warm-up, loading, cooling, and relaxation exercises are shown. The warm-up period is consist of light-paced walking, active movements of several large muscle groups. During the loading period, taking into consideration the heart rate, fatigue and shortness of breath, exercises such as walking, squat, limb movements with weights, stepping on the steps, walking on different floors are shown. Stretching exercises are done during the cooling period. Intermittent loading workouts will consist of 3-minute loads and 1-minute rest intervals. Moderate aerobic exercise is consist of brisk walking to reach 60-85% of the person's maximum heart rate. Participants of the experimental group are contacted every two weeks via communication methods such as e-mail, message and telephone conversation. Exercise diary is given to all patients and is taken from them at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent Exercise Group | Experimental | Other: Intermittent ExerciseWarm-up, loading (walking, squat, sitting down on a chair, limb movements with weights, stepping on steps, walking on different floors), cooling and relaxation exercises |
| Control Group | Active comparator | Other: ControlWarm-up, loading (brisk walking at 60-85% of maximum heart rate), cooling and relaxation exercises |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having had MI at least 3 months ago
- Stable clinical status for at least two weeks
- Walking independently
- Volunteer for research study
Key exclusion criteria (5 listed)
- Having unstable angina
- Having uncontrolled hypertension
- Having hemodynamic instability
- Participating in any exercise program in the last six months
- Having a major orthopedic or neurological problem that limits functionality
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 |
|---|---|---|
| Intermittent ExerciseExercise programs including warm-up, loading, cooling, and relaxation exercises are shown. The warm-up period is consist of light-paced walking, active movements of several large muscle groups. During the loading period, taking into consideration the heart rate, fatigue and shortness of breath, exercises such as walking, squat, limb movements with weights, stepping on the steps, walking on different floors are shown. Stretching exercises are done during the cooling period. Intermittent loading workouts will consist of 3-minute loads and 1-minute rest intervals. Participants are contacted every two weeks via communication methods such as e-mail, message and telephone conversation. Exercise diary is given to all patients and is taken from them at the end of the study. | Other | Intermittent Exercise Group |
| ControlExercise programs including warm-up, loading, cooling, and relaxation exercises are shown. The warm-up period is consist of light-paced walking, active movements of several large muscle groups. In loading period, moderate aerobic exercise is consist of brisk walking to reach 60-85% of the person's maximum heart rate. Stretching exercises are done during the cooling period. | Other | Control Group |
Primary outcome
Change in functional capacity
Time frame: Baseline, 12th week
Six-minute walk test (6MWT) is a valid, reliable and useful test for assessing functional capacity of patients. This test assesses distance walked over 6 minutes as a sub maximal test of aerobic capacity/endurance.
Change in peripheral muscle strength
Time frame: Baseline, 12th week
The Jamar Handgrip Dynamometer is an instrument for measuring the maximum isometric strength of the hand and forearm muscles. Quadriceps isometric muscle strength is measured with a Hand Held Dynamometer.
Change in respiratory muscle strength
Time frame: Baseline, 12th week
Measurement of respiratory muscle strength is useful in order to detect respiratory muscle weakness and to quantify its severity. Respiratory muscle strength is assessed by mouth pressures sustained for 1 s during maximal static manoeuvre against a closed shutter.
Change in FEV1
Time frame: Baseline, 12th week
FEV1 is the maximal amount of air which is forcefully exhale in one second. It is then converted to a percentage of normal predicted based on height, weight, and race.
Change in FVC
Time frame: Baseline, 12th week
Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from lungs after taking the deepest breath possible, as measured by spirometry.
Change in FEV1/FVC
Time frame: Baseline, 12th week
Also known as Tiffeneau-Pinelli index, FEV1/FVC ratio is often used in diagnosing and treating lung diseases. The FEV1/FVC ratio is a measurement of the amount of air you can forcefully exhale from your lungs.
Change in PEF
Time frame: Baseline, 12th week
Peak expiratory flow (PEF) is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration, measured in liters per minute or in liters per second.
10 secondary outcomes
Change in weight
Time frame: Baseline, 12th week
Change in body mass index
Time frame: Baseline, 12th week
Change in body fat percentage
Time frame: Baseline, 12th week
Change in lean body mass
Time frame: Baseline, 12th week
Change in severity of dyspnoea
Time frame: Baseline, 12th week
Change in The Tampa Kinesiophobia Scale for Heart Patients
Time frame: Baseline, 12th week
Change in The International Physical Activity Questionnaire-short form
Time frame: Baseline, 12th week
Change in The Fatigue Severity Scale
Time frame: Baseline, 12th week
Change in The Hospital Anxiety and Depression Scale
Time frame: Baseline, 12th week
Change in MacNew Heart Disease Health-Related Quality of Life instrument
Time frame: Baseline, 12th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Derived from this study: PubMed 34993836Yakut H, Dursun H, Felekoglu E, Baskurt AA, Alpaydin AO, Ozalevli S. Effect of home-based high-intensity interval training versus moderate-intensity continuous training in patients with myocardial infarction: a randomized controlled trial. Ir J Med Sci. 2022 Dec;191(6):2539-2548. doi: 10.1007/s11845-021-02867-x. Epub 2022 Jan 7.
- Derived from this study: PubMed 34741536Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.
Related trials for Myocardial Infarction
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
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.
Hazal Yakut, PT, MSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Exercise in people with Myocardial Infarction, run by Dokuz Eylul 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 May 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elvan Keleş, PT, MSc (0902323293535, elvan_keles@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in functional capacity (time frame: Baseline, 12th week). The study lists 7 primary outcomes in all. 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 NCT04407624, which also lists 2 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 29 May 2020.