NCT06564597

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2022

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2025

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

August 19, 2024

Last Update Submit

April 6, 2026

Conditions

Keywords

Myocardial IschemiaActivities of Daily LivingMetabolic Equivalent

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    The evaluation were completed after discharge. The exact time is post-operative 2nd week, 3th month and 6th month.

Study Arms (2)

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

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

Other: Patient education

Interventions

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.

Verbal education and two brochure handoutsVerbal education, two brochure handouts and MET-based activity planning

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of myocardial infarction (ST elevation or non-ST elevation)
  • Ejection fraction \> 40%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Merkez, Denizli, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 34497468BACKGROUND
  • 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.

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • ALI KITIS, Professor

    Pamukkale University Faculty of Physiotherapy and Rehabilitation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 19, 2024

First Posted

August 21, 2024

Study Start

April 29, 2022

Primary Completion

April 29, 2025

Study Completion

October 29, 2025

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations