Implementation, Safety, and Effectiveness of Outpatient Cardiac Telerehabilitation in Patients With Ischemic Heart Disease
NCT07927829, Not applicable, Recruiting, Lithuanian University of Health Sciences
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Implementation, Safety, and Effectiveness of Outpatient Cardiac Telerehabilitation in Patients With Ischemic Heart Disease | ClinicalTrials.gov |
| NCT number | NCT07927829 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 100 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Lithuanian University of Health Sciences | ClinicalTrials.gov |
| Conditions | Ischemic Heart Disease, Cardiac Telerehabilitation, Telemedicine | ClinicalTrials.gov |
| Interventions | Conventional outpatient cardiac rehabilitation, Cardiac telerehabilitation | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Cardiopulmonary Exercise Test | From enrollment to the end of treatment at 3 weeks | 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 | ClinicalTrials.gov |
| Primary | Six-Minute Walk Test | From enrollment to the end of treatment at 3 weeks | 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. | ClinicalTrials.gov |
| Primary | International Physical Activity Questionnaire - Short Form | From enrollment to the end of treatment at 3 weeks | 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. | ClinicalTrials.gov |
| Secondary | Fullerton Advanced Balance Scale | From enrollment to the end of treatment at 3 weeks | 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. | ClinicalTrials.gov |
| Secondary | Fagerström Test | From enrollment to the end of treatment at 3 weeks | 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). | ClinicalTrials.gov |
| Secondary | Coronary Artery Disease Education Questionnaire - Short Version | From enrollment to the end of treatment at 3 weeks | 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. | ClinicalTrials.gov |
| Secondary | Self-Care of Coronary Heart Disease Inventory | From enrollment to the end of treatment at 3 weeks | 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. | ClinicalTrials.gov |
| Secondary | Mediterranean Diet Adherence Screener | From enrollment to the end of treatment at 3 weeks | 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). | ClinicalTrials.gov |
| Secondary | Pittsburgh Sleep Quality Index | From enrollment to the end of treatment at 3 weeks | 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. | ClinicalTrials.gov |
| Secondary | EuroQol Five-Dimension Five-Level Questionnaire | From enrollment to the end of treatment at 3 weeks | 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. | ClinicalTrials.gov |
| Secondary | System Usability Scale | From enrollment to the end of treatment at 3 weeks | 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). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 5
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)