- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06564597
Activity-based Training After Myocardial Infarction
April 6, 2026 updated by: HANDE USTA, Pamukkale University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Denizli
-
Merkez, Denizli, Turkey (Türkiye)
- Pamukkale University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosis of myocardial infarction (ST elevation or non-ST elevation)
- Ejection fraction > 40%
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Verbal education and two brochure handouts
The educational brochures are prepared to include clear, legible, realistic and up-to-date information. The context of the education includes the following topics:
|
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.
|
|
Experimental: Verbal education, two brochure handouts and MET-based activity planning
The educational brochures are prepared to include clear, legible, realistic and up-to-date information. The context of the education includes the following topics:
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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.
|
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
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.
|
The evaluation were completed after discharge. The exact time is post-operative 2nd week, 3th month and 6th month.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: ALI KITIS, Professor, Pamukkale University Faculty of Physiotherapy and Rehabilitation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- CAIN 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 29, 2022
Primary Completion (Actual)
April 29, 2025
Study Completion (Actual)
October 29, 2025
Study Registration Dates
First Submitted
August 19, 2024
First Submitted That Met QC Criteria
August 19, 2024
First Posted (Actual)
August 21, 2024
Study Record Updates
Last Update Posted (Actual)
April 13, 2026
Last Update Submitted That Met QC Criteria
April 6, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-60116787-020-205945
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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