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NCT07927829
Implementation, Safety, and Effectiveness of Outpatient Cardiac Telerehabilitation in Patients With Ischemic Heart Disease
Conditions: Ischemic Heart Disease, Cardiac Telerehabilitation, Telemedicine
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Lithuanian University of Health Sciences
Location: Kulautuva Rehabilitation Hospital Kulautuva
Summary
The goal of this prospective interventional study is to evaluate the effectiveness and safety of an outpatient cardiac telerehabilitation program during phase II rehabilitation in patients with ischemic heart disease. The main question is whether an outpatient cardiac telerehabilitation program during phase II rehabilitation is effective and safe for patients with ischemic heart disease.
Researchers will compare two groups:
1. Control group - conventional outpatient cardiac rehabilitation at Kulautuva Rehabilitation Hospital.
2. Intervention group - outpatient cardiac telerehabilitation delivered through a hybrid model, in which patient assessments, consultations, and other prescribed procedures are conducted at Kulautuva Rehabilitation Hospital, while patient education and exercise training programs are delivered remotely in an asynchronous manner. Smart wearable devices will monitor physiological parameters and physical activity, supporting individualized exercise recommendations.
During the study, researchers will collect and assess participants' medical history, existing risk factors, and current medications. Study participants will undergo the following tests:
* Cardiopulmonary Exercise Testing (CPET);
* Six-Minute Walk Test (6MWT);
* International Physical Activity Questionnaire - Short Form (IPAQ-SF);
* Fullerton Advanced Balance Scale (FAB);
* Fagerström Test for Nicotine Dependence (FTND) (for participants who smoke);
* Coronary Artery Disease Education Questionnaire - Short Version (CADE-Q SV);
* Self-Care of Coronary Heart Disease Inventory (SC-CHDI V2.1);
* Mediterranean Diet Adherence Screener (MEDAS);
* Pittsburgh Sleep Quality Index (PSQI);
* EuroQol Five-Dimension Questionnaire (EQ-5D);
* System Usability Scale (SUS) (only for participants in the intervention group).
Eligibility Criteria
Inclusion Criteria:
1. Patients diagnosed with ischemic heart disease and referred to Phase II outpatient cardiac rehabilitation;
2. Adults aged 18 years and older;
3. Moderate to good functional exercise capacity, defined as a distance \> 225 meters on the Six-Minute Walk Test at baseline;
4. Willingness and ability to provide written informed consent to participate in the study.
Exclusion Criteria:
1. Presence of implanted cardiac devices;
2. Language barriers that may interfere with study participation;
3. Cognitive impairment, defined as a Mini-Mental State Examination score \< 25 points;
4. Comorbidities that may significantly affect the participant's ability to perform physical exercises, mobility, or activities of daily living, including musculoskeletal disorders, neurological diseases, or other relevant medical conditions;
5. Insufficient digital literacy or inability to use smart devices.
Source: ClinicalTrials.gov (NCT07927829). StuddyBuddy aggregates publicly available trial information.