Myocardial IschemiaNCT06564597
Activity-based Training After Myocardial Infarction
A study testing Patient education in people with Myocardial Ischemia and Activities of Daily Living, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Cardiovascular diseases cause high morbidity and mortality, resulting in disability, medical complications and comorbidities. Patients who have MI experience motor, cognitive and sensory impairments, reduced quality of life and burdened the national economy. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Myocardial Ischemia, Activities of Daily Living
- What is being tested?
- Patient education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Apr 2022to 29 Oct 2025
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of myocardial infarction (ST elevation or non-ST elevation)
- Ejection fraction > 40%
Who cannot join
- Ejection fraction < 40%
- Presence of exercise-induced ischemia
- Presence of orthopedic or neurological disorder that will affect the current study
- Presence of pulmonary disease that will affect the current study (COPD, Asthma)
- Presence of visual impairment
- Presence of malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Activity-based Training After Myocardial Infarction: A Randomized Controlled Study
Cardiovascular diseases cause high morbidity and mortality, resulting in disability, medical complications and comorbidities. Patients who have MI experience motor, cognitive and sensory impairments, reduced quality of life and burdened the national economy. Cardiac rehabilitation aims to optimize patients' health services, reduce physical and psychological effects and increase activity return performance. The rehabilitation process includes physical activities and patient education starting in the early stages after MI. Psychosocial support and occupational therapy can accelerate patients' recovery and return to daily activities. Since there are inadequacies in the literature on this subject, this study aims to provide an effective educational intervention for patients who have MI and to examine a safe return to activity.
- Conditions
- Myocardial Ischemia, Activities of Daily Living
- Being tested
- Patient education
- Keywords
- Myocardial Ischemia, Activities of Daily Living, Metabolic Equivalent
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient educationOther
Patient education and counseling are offered one-on-one at the bedside during discharge and are also provided in the second week after discharge in an outpatient clinic setting.
| Study group | Role | What they receive |
|---|---|---|
| Verbal education and two brochure handouts | Experimental | The educational brochures are prepared to include clear, legible, realistic and up-to-date information. The context of the education includes the following topics:
* What is myocardial infarction?
* What are its clinical features?
* Risk factors
* Lifestyle changes
* What is cardiac rehabilitation?
* Stress and anxiety management
* Energy conservation techniques
* Progressive relaxation techniques Receives: Other: Patient education |
| Verbal education, two brochure handouts and MET-based activity planning | Experimental | The educational brochures are prepared to include clear, legible, realistic and up-to-date information. The context of the education includes the following topics:
* What is myocardial infarction?
* What are its clinical features?
* Risk factors
* Lifestyle changes
* What is cardiac rehabilitation?
* Return to activity and activity-based prescription (based on MET)
* What are the abnormal responses that may occur in activities?
* Stress and anxiety management
* Energy conservation techniques
* Progressive relaxation techniques Receives: Other: Patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure
The Canadian Occupational Performance Measure is an evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time.
Measured: The evaluation were completed after discharge. The exact time is post-operative 2nd week, 3th month and 6th month.
Katz Index of Independence in Activities of Daily Living
The Katz Index of Independence in Activities of Daily Living, commonly referred to as the Katz ADL, is the most appropriate instrument to assess functional status as a measurement of the client's ability to perform activities of daily living independently.
Measured: The evaluation were completed after discharge. The exact time is post-operative 2nd week, 3th month and 6th month.
Lawton Brody Instrumental Activities of Daily Living Scale
The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills. These skills are considered more complex than the basic activities of daily living as measured by the Katz Index of ADLs.
Measured: The evaluation were completed after discharge. The exact time is post-operative 2nd week, 3th month and 6th month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start29 Apr 2022
- Primary completion29 Apr 2025
- Study completion29 Oct 2025
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 IschemiaStudies 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
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HANDE USTA, Pamukkale University
- Investigators
- ALI KITIS, Professor, Study chair, Pamukkale University Faculty of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564597
- Sponsor's protocol ID
- E-60116787-020-205945
- Status last verified
- Apr 2026
- First submitted
- 19 Aug 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Graham H, Prue-Owens K, Kirby J, Ramesh M. Systematic Review of Interventions Designed to Maintain or Increase Physical Activity Post-Cardiac Rehabilitation Phase II. Rehabil Process Outcome. 2020 Aug 25;9:1179572720941833. doi: 10.1177/1179572720941833. eCollection 2020.
PubMed 34497468CAIN HD, FRASHER WG Jr, STIVELMAN R. Graded activity program for safe return to self-care after myocardial infarction. JAMA. 1961 Jul 15;177:111-5. doi: 10.1001/jama.1961.03040280015005. No abstract available.
PubMed 13689828
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Activity-based Training After Myocardial Infarction: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06564597
- Acronym / sponsor ID
- E-60116787-020-205945
- Conditions
- Myocardial Ischemia, Activities of Daily Living
- Keywords
- Myocardial Ischemia, Activities of Daily Living, Metabolic Equivalent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 29 Apr 2025 (actual)
- Study completion
- 29 Oct 2025 (actual)
- First posted
- 21 Aug 2024 (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 cause high morbidity and mortality, resulting in disability, medical complications and comorbidities. Patients who have MI experience motor, cognitive and sensory impairments, reduced quality of life and burdened the national economy. Cardiac rehabilitation aims to optimize patients' health services, reduce physical and psychological effects and increase activity return performance. The rehabilitation process includes physical activities and patient education starting in the early stages after MI. Psychosocial support and occupational therapy can accelerate patients' recovery and return to daily activities. Since there are inadequacies in the literature on this subject, this study aims to provide an effective educational intervention for patients who have MI and to examine a safe return to activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verbal education and two brochure handouts | Experimental | Other: Patient educationThe educational brochures are prepared to include clear, legible, realistic and up-to-date information. The context of the education includes the following topics: * What is myocardial infarction? * What are its clinical features? * Risk factors * Lifestyle changes * What is cardiac rehabilitation? * Stress and anxiety management * Energy conservation techniques * Progressive relaxation techniques |
| Verbal education, two brochure handouts and MET-based activity planning | Experimental | Other: Patient educationThe educational brochures are prepared to include clear, legible, realistic and up-to-date information. The context of the education includes the following topics: * What is myocardial infarction? * What are its clinical features? * Risk factors * Lifestyle changes * What is cardiac rehabilitation? * Return to activity and activity-based prescription (based on MET) * What are the abnormal responses that may occur in activities? * Stress and anxiety management * Energy conservation techniques * Progressive relaxation techniques |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of myocardial infarction (ST elevation or non-ST elevation)
- Ejection fraction > 40%
Key exclusion criteria (6 listed)
- Ejection fraction < 40%
- Presence of exercise-induced ischemia
- Presence of orthopedic or neurological disorder that will affect the current study
- Presence of pulmonary disease that will affect the current study (COPD, Asthma)
- Presence of visual impairment
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 |
|---|---|---|
| Patient educationPatient education and counseling are offered one-on-one at the bedside during discharge and are also provided in the second week after discharge in an outpatient clinic setting. | Other | Verbal education and two brochure handouts, Verbal education, two brochure handouts and MET-based activity planning |
Primary outcome
Canadian Occupational Performance Measure
Time frame: The evaluation were completed after discharge. The exact time is post-operative 2nd week, 3th month and 6th month.
The Canadian Occupational Performance Measure is an evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time.
Katz Index of Independence in Activities of Daily Living
Time frame: The evaluation were completed after discharge. The exact time is post-operative 2nd week, 3th month and 6th month.
The Katz Index of Independence in Activities of Daily Living, commonly referred to as the Katz ADL, is the most appropriate instrument to assess functional status as a measurement of the client's ability to perform activities of daily living independently.
Lawton Brody Instrumental Activities of Daily Living Scale
Time frame: The evaluation were completed after discharge. The exact time is post-operative 2nd week, 3th month and 6th month.
The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills. These skills are considered more complex than the basic activities of daily living as measured by the Katz Index of ADLs.
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 13 Apr 2026.
- Background: PubMed 34497468Graham H, Prue-Owens K, Kirby J, Ramesh M. Systematic Review of Interventions Designed to Maintain or Increase Physical Activity Post-Cardiac Rehabilitation Phase II. Rehabil Process Outcome. 2020 Aug 25;9:1179572720941833. doi: 10.1177/1179572720941833. eCollection 2020.
- Results publication: PubMed 13689828CAIN HD, FRASHER WG Jr, STIVELMAN R. Graded activity program for safe return to self-care after myocardial infarction. JAMA. 1961 Jul 15;177:111-5. doi: 10.1001/jama.1961.03040280015005. No abstract available.
- 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.
ALI KITIS, Professor study chair
Pamukkale University Faculty of Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education in people with Myocardial Ischemia and Activities of Daily Living, run by Pamukkale 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 2 inclusion and 6 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 13 Apr 2026. 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?
Canadian Occupational Performance Measure (time frame: The evaluation were completed after discharge. The exact time is post-operative 2nd week, 3th month and 6th month.). The study lists 3 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 NCT06564597, 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 13 Apr 2026.