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- Klinische proef NCT07927829
Implementation, Safety, and Effectiveness of Outpatient Cardiac Telerehabilitation in Patients With Ischemic Heart Disease
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:
- Control group - conventional outpatient cardiac rehabilitation at Kulautuva Rehabilitation Hospital.
- 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).
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Emilija Laurecke
- Telefoonnummer: +37064537135
- E-mail: emilija.laurecke@stud.lsmu.lt
Studie Locaties
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Kulautuva, Litouwen
- Werving
- Kulautuva Rehabilitation Hospital
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Contact:
- Raimondas Kubilius
- Telefoonnummer: +37037536696
- E-mail: kulautuvos.reabilitacijos.ligonine@kaunoklinikos.lt
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Onderonderzoeker:
- Egle Tamuleviciute-Prasciene
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Onderonderzoeker:
- Julija Borkyte-Sileikiene
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Onderonderzoeker:
- Raimondas Kubilius
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Patients diagnosed with ischemic heart disease and referred to Phase II outpatient cardiac rehabilitation;
- Adults aged 18 years and older;
- Moderate to good functional exercise capacity, defined as a distance > 225 meters on the Six-Minute Walk Test at baseline;
- Willingness and ability to provide written informed consent to participate in the study.
Exclusion Criteria:
- Presence of implanted cardiac devices;
- Language barriers that may interfere with study participation;
- Cognitive impairment, defined as a Mini-Mental State Examination score < 25 points;
- 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;
- Insufficient digital literacy or inability to use smart devices.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Conventional outpatient cardiac rehabilitation
Conventional outpatient cardiac rehabilitation at Kulautuva Rehabilitation Hospital |
Participants receive comprehensive, individualized rehabilitation care tailored to their primary diagnosis and comorbidities. The rehabilitation program include: aerobic exercise on a cycle ergometer or treadmill (6 sessions/week), breathing exercises (6 sessions/week), strength and balance training (3 sessions/week), and aquatic exercise or Nordic walking, depending on the patient's clinical condition (2-3 sessions/week) |
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Experimenteel: Cardiac Telerehabilitation
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 |
Cardiac telerehabilitation is delivered through a hybrid model. In-person assessments, consultations, and other prescribed procedures are conducted at the Kulautuva Rehabilitation Hospital. At the same time, patients receive education and exercise training remotely at home using smart devices. Participants receive an individualized exercise program with exercise intensity tailored to their cardiovascular risk and physical capacity. Each participant is enrolled in the telemedicine platform, where a personalized home-based rehabilitation and health-monitoring plan is developed, including medication management, exercise training, and monitoring of relevant health parameters. Participants receive the necessary equipment. Additionally, participants in the intervention group receive a consultation with a physiotherapist about their home-based exercise program, along with training on proper use of wearable devices and mobile applications. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Cardiopulmonary Exercise Test
Tijdsspanne: From enrollment to the end of treatment at 3 weeks
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This test will be performed to assess participants' cardiorespiratory fitness and exercise capacity. The test will be conducted using a cycle ergometer with respiratory gas analysis and electrocardiographic (ECG) monitoring. Exercise capacity will be assessed using an ergometer, starting at 25 W and increasing by 25 W every minute. Participants will be instructed to maintain a constant pedaling cadence of 50-60 revolutions per minute to ensure a stable workload. The progressive exercise duration is 8-12 minutes, depending on each participant's physical capacity and clinical condition, followed by a recovery period. During the test, blood pressure, heart rate, and ECG will be monitored, while oxygen uptake (VO₂), carbon dioxide production (VCO₂), minute ventilation (VE), maximal oxygen uptake (VO₂max), and ventilatory thresholds (VT1 and VT2) will be assessed. The heart rates corresponding to VT1 and VT2 will be identified and used to establish individualized aerobic exercise intensity |
From enrollment to the end of treatment at 3 weeks
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Six-Minute Walk Test
Tijdsspanne: From enrollment to the end of treatment at 3 weeks
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This test assesses functional exercise capacity. Participants will be instructed to walk in an indoor corridor at a self-selected pace. Participants may slow down, stop, or rest as needed and resume walking when able. The total distance walked in six minutes (in meters) will be recorded as the primary outcome. Heart rate, blood pressure, and perceived exertion using the Borg scale will be assessed before and after the test. |
From enrollment to the end of treatment at 3 weeks
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International Physical Activity Questionnaire - Short Form
Tijdsspanne: From enrollment to the end of treatment at 3 weeks
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This standardized, self-reported questionnaire evaluates physical activity in adults. The questionnaire consists of seven items assessing the frequency and duration of physical activity performed during the previous seven days, including walking, moderate-intensity physical activity, vigorous-intensity physical activity, and time spent sitting. The questionnaire score will be quantified in metabolic equivalents. Participants will be classified into three physical activity categories: low, moderate, or high. |
From enrollment to the end of treatment at 3 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Fullerton Advanced Balance Scale
Tijdsspanne: From enrollment to the end of treatment at 3 weeks
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This standardized, performance-based assessment evaluates static and dynamic balance. The test includes 10 tasks that assess different aspects of postural control, including standing with feet together and eyes closed, reaching forward, turning, stepping over obstacles, tandem walking, standing on one leg, and maintaining balance during other functional activities. Each task is scored on a five-point scale ranging from 0 (unable to perform the task) to 4 (optimal performance), resulting in a maximum total score of 40 points. Higher scores indicate better balance performance, while lower scores suggest greater balance impairment. |
From enrollment to the end of treatment at 3 weeks
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Fagerström Test
Tijdsspanne: From enrollment to the end of treatment at 3 weeks
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This standardized, self-report questionnaire evaluates nicotine dependence. It includes six items assessing smoking behavior, such as the number of cigarettes smoked per day, time to the first cigarette after waking, difficulty refraining from smoking, and smoking patterns throughout the day. Each item is scored 0 to 10 points. Higher scores indicate greater nicotine dependence. Participants will be classified into five categories based on their total score: very low dependence (0-2 points), low dependence (3-4 points), moderate dependence (5 points), high dependence (6-7 points), and very high dependence (8-10 points). |
From enrollment to the end of treatment at 3 weeks
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Coronary Artery Disease Education Questionnaire - Short Version
Tijdsspanne: From enrollment to the end of treatment at 3 weeks
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This standardized, self-reported questionnaire evaluates disease-related knowledge among patients participating in cardiac rehabilitation programs. The questionnaire consists of 20 items divided into five knowledge domains: medical condition, cardiovascular risk factors, exercise, nutrition, and psychosocial risk. Each domain includes four questions. Participants are required to select one of three response options: "True", "False", or "I don't know". Each correct answer is worth 1 point, while incorrect answers and "I don't know" responses are worth 0 points. The total score ranges from 0 to 20 points, with higher scores indicating greater knowledge of coronary artery disease and its management. |
From enrollment to the end of treatment at 3 weeks
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Self-Care of Coronary Heart Disease Inventory
Tijdsspanne: From enrollment to the end of treatment at 3 weeks
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This standardized, self-report questionnaire assesses patients' ability to maintain health, manage disease-related symptoms, and engage in appropriate self-care behaviors. It comprises 22 items across three domains: self-care maintenance (10 items), self-care management (6 items), and self-care confidence (6 items). Each domain is scored separately, with scores standardized to a 0-100 scale. Higher scores indicate better self-care behaviors or greater confidence in self-care management. |
From enrollment to the end of treatment at 3 weeks
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Mediterranean Diet Adherence Screener
Tijdsspanne: From enrollment to the end of treatment at 3 weeks
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This standardized, self-reported questionnaire evaluates dietary habits and adherence to the principles of the Mediterranean dietary pattern. The questionnaire includes 14 items that assess the frequency and quantity of key dietary components, including olive oil, vegetables, fruits, legumes, nuts, fish, meat, and other food products, as well as specific dietary habits. Each item is scored as either 0 or 1 point, depending on whether the participant meets the predefined dietary criterion. The total score ranges from 0 to 14 points, with higher scores indicating greater adherence to the Mediterranean diet. Participants will be categorized into three groups: low adherence (0-5 points), moderate adherence (6-9 points), and high adherence (10-14 points). |
From enrollment to the end of treatment at 3 weeks
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Pittsburgh Sleep Quality Index
Tijdsspanne: From enrollment to the end of treatment at 3 weeks
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This standardized, self-report questionnaire assesses subjective sleep quality and sleep disturbances over the previous month. It comprises 19 items grouped into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A bed partner or roommate may complete additional questions, but these are not included in the overall score. Each component is scored 0 to 3 points, resulting in a total score of 0 to 21 points. Higher scores indicate poorer sleep quality; a total score greater than 5 points indicates poor sleep quality. |
From enrollment to the end of treatment at 3 weeks
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EuroQol Five-Dimension Five-Level Questionnaire
Tijdsspanne: From enrollment to the end of treatment at 3 weeks
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This standardized, self-reported instrument evaluates participants' perceived health status and quality of life. The questionnaire assesses five health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension uses five response levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Higher questionnaire index values generally indicate better health-related quality of life. |
From enrollment to the end of treatment at 3 weeks
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System Usability Scale
Tijdsspanne: From enrollment to the end of treatment at 3 weeks
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This standardized, self-reported questionnaire assesses participants' perceptions of system usability, ease of use, and overall user experience. The questionnaire consists of 10 statements ranging from 1 (strongly disagree) to 5 (strongly agree). The total scale score ranges from 0 to 100 points, with higher scores indicating better perceived usability. Usability is classified as excellent (>80.3 points), good (68-80.3 points), poor (51-<68 points), or very poor (<51 points). |
From enrollment to the end of treatment at 3 weeks
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Medewerkers en onderzoekers
Publicaties en nuttige links
Algemene publicaties
- Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
- Hyzy M, Bond R, Mulvenna M, Bai L, Dix A, Leigh S, Hunt S. System Usability Scale Benchmarking for Digital Health Apps: Meta-analysis. JMIR Mhealth Uhealth. 2022 Aug 18;10(8):e37290. doi: 10.2196/37290.
- Klein PJ, Fiedler RC, Rose DJ. Rasch Analysis of the Fullerton Advanced Balance (FAB) Scale. Physiother Can. 2011 Winter;63(1):115-25. doi: 10.3138/ptc.2009-51. Epub 2011 Jan 20.
- Kabbadj K, Taiek N, El Hjouji W, El Karrouti O, El Hangouche AJ. Cardiopulmonary Exercise Testing: Methodology, Interpretation, and Role in Exercise Prescription for Cardiac Rehabilitation. US Cardiol. 2024 Dec 20;18:e22. doi: 10.15420/usc.2024.37. eCollection 2024.
- A. Asyrah. Guidelines for Data Processing and Analysis of the International Physical Activity Questionnaire (IPAQ) - Short and Long Forms Contents. Available: https://share.google/27a6dNwjJUSDoloBD.
- Papadaki A, Johnson L, Toumpakari Z, England C, Rai M, Toms S, Penfold C, Zazpe I, Martinez-Gonzalez MA, Feder G. Validation of the English Version of the 14-Item Mediterranean Diet Adherence Screener of the PREDIMED Study, in People at High Cardiovascular Risk in the UK. Nutrients. 2018 Jan 28;10(2):138. doi: 10.3390/nu10020138.
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- BE-2-67/2026
Plan Individuele Deelnemersgegevens (IPD)
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Beschrijving IPD-plan
Individual participant data will not be shared to protect participant privacy and ensure the confidentiality of sensitive health information. However, the study results will be shared through scientific publications.
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