ClinicalTrials.gg
RecruitingNCT07927829Updated Nov 10, 2026

Implementation, Safety, and Effectiveness of Outpatient Cardiac Telerehabilitation in Patients With Ischemic Heart Disease

An interventional study of Conventional outpatient cardiac rehabilitation and Cardiac telerehabilitation in Ischemic Heart Disease, Cardiac Telerehabilitation and Telemedicine, sponsored by Lithuanian University of Health Sciences. Recruiting at 1 site in Lithuania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Lithuanian University of Health Sciences · Not applicable, Interventional, and Treatment

Updated Nov 10, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).
02

Conditions studied

  • Ischemic Heart Disease
  • Cardiac Telerehabilitation
  • Telemedicine

Browse trials for

Keywords

  • Ischemic heart disease
  • Cardiac telerehabilitation
  • Cardiac rehabilitation
  • Telemedicine
03

In context

Myocardial Ischemia

1,123 studies on the registry are indexed under Myocardial Ischemia; 177 are open to participants now.

This study's planned enrollment of 100 is below the median of 116 across 622 interventional studies indexed under Myocardial Ischemia.

Browse Myocardial Ischemia studies →

Lead sponsor

Lithuanian University of Health Sciences is the lead sponsor of 105 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 to participate in the study.

Exclusion criteria

Exclusion Criteria:

  1. Presence of implanted cardiac devices;
  2. Language barriers that may interfere with study participation;
  3. Cognitive impairment, defined as a 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Conventional outpatient cardiac rehabilitation

    Conventional outpatient cardiac rehabilitation at Kulautuva Rehabilitation Hospital

    Other: Conventional outpatient cardiac rehabilitation

  • Experimental
    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

    Other: Cardiac telerehabilitation

Interventions

  • OtherConventional outpatient cardiac rehabilitation

    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)

  • OtherCardiac telerehabilitation

    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.

06

What researchers measure

Primary outcomes

  1. Cardiopulmonary Exercise Test

    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

    Time frame: From enrollment to the end of treatment at 3 weeks

  2. Six-Minute Walk Test

    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.

    Time frame: From enrollment to the end of treatment at 3 weeks

  3. International Physical Activity Questionnaire - Short Form

    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.

    Time frame: From enrollment to the end of treatment at 3 weeks

Secondary outcomes

  1. Fullerton Advanced Balance Scale

    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.

    Time frame: From enrollment to the end of treatment at 3 weeks

  2. Fagerström Test

    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).

    Time frame: From enrollment to the end of treatment at 3 weeks

  3. Coronary Artery Disease Education Questionnaire - Short Version

    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.

    Time frame: From enrollment to the end of treatment at 3 weeks

  4. Self-Care of Coronary Heart Disease Inventory

    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.

    Time frame: From enrollment to the end of treatment at 3 weeks

  5. Mediterranean Diet Adherence Screener

    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).

    Time frame: From enrollment to the end of treatment at 3 weeks

  6. Pittsburgh Sleep Quality Index

    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.

    Time frame: From enrollment to the end of treatment at 3 weeks

  7. EuroQol Five-Dimension Five-Level Questionnaire

    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.

    Time frame: From enrollment to the end of treatment at 3 weeks

  8. System Usability Scale

    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).

    Time frame: From enrollment to the end of treatment at 3 weeks

07

Study locations

1 of 1 sites recruiting
  • Kulautuva Rehabilitation Hospital
    Kulautuva, Lithuania
    Recruiting
08

References and documents

Publications

  • 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.
  • 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. PubMed 22210989 ↗
  • 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. PubMed 25359355 ↗
  • 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. PubMed 35980732 ↗
  • 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. PubMed 29382082 ↗
  • 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. PubMed 39872828 ↗

Individual participant data

Plan to share: No — 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.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2030, 48 months later.

Of 155 non-industry interventional studies with no phase under Myocardial Ischemia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 56. This study's planned 48 months is above that.

Counting every sponsor, half of 192 studies reached it within 34 months; a quarter within 15 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 4, 2026
First posted
Nov 10, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
Nov 1, 2030
CompletionEst.
Nov 1, 2030
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07927829
Responsible party
Emilija Laurecke (PhD Student, Lithuanian University of Health Sciences) — Principal investigator
First posted
Nov 10, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Nov 1, 2030 (estimated)
Completion
Nov 1, 2030 (estimated)
Last update
Nov 10, 2026

Study contacts

Emilija Laurecke
Contact
emilija.laurecke@stud.lsmu.lt
+37064537135

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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