Cardiovascular Diseases Clinical Trial
— TELE-WEAROfficial title:
TELE - WEAR: a Multi - Centre, Blinded, Randomized Controlled Trial Investigating the Efficacy, Efficiency and Cost - Effectiveness of a Cardiac Telerehabilitation Program Using Wearable Sensors (TELE - WEAR). Rationale and Study Design
Objective: To evaluate the efficacy, efficiency and cost - effectiveness of a cardiac telerehabilitation program using wearable sensors Design: Supervised single-blinded randomized controlled trial, comparing three groups, with follow-ups at baseline, 12 weeks (completion of the intervention), 6 months after the completion of the intervention Setting: cardiac rehabilitation centres, patients home environments Participants: A total of 102 cardiac patients, regardless sex, aged 18 years and older were randomly assigned to a telerehabilitation group (n = 34), a centre - based cardiac rehabilitation group(n=34) and a usual care control group (n = 34). Interventions: Exercise - based cardiac rehabilitation program for the intervention groups (both in cardiac clinics' settings and in patients' homes) consisted of three sessions each week for 12 consecutive weeks. The control group received no exercise intervention. Measurements: Main outcome was measured by Cardiopulmonary Exercise Testing. Secondary outcomes were measured by accelerometry and the use of proper questionnaires.
Status | Not yet recruiting |
Enrollment | 102 |
Est. completion date | January 2023 |
Est. primary completion date | November 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - adults aged =18 years - stable cardiovascular disease ; acute coronary syndrome; coronary artery bypass grafting within the previous six months - ability to perform physical exercise, - to speak, read and write Greek - possession of a mobile phone/smartphone - internet access at home Exclusion Criteria: - ventricular arrhythmia or myocardial ischemia during low to moderate exercise intensity as assessed by symptom limited exercise testing at baseline - heart failure New York Heart Association (NYHA) class IV - comorbidity precluding exercise training (e.g. orthopaedic, neurological or cognitive conditions) - acute myocardial infarction (within two days) - stenosis - unstable angina - uncontrolled atrial or ventricular arrhythmia - aortic uncontrolled congestive heart failure - acute pulmonary embolism - acute myocarditis or pericardial effusion - uncontrolled diabetes mellitus (Type I, II) - hemodynamic instability or exercise-induced arrhythmia in baseline (initial) assessment - severe obstructive respiratory disease |
Country | Name | City | State |
---|---|---|---|
Greece | University of Thessaly | Lamia |
Lead Sponsor | Collaborator |
---|---|
Garyfallia Pepera |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the levels of physical fitness | Physical fitness will be assessed in all study groups by peak oxygen uptake, determined by cardiopulmonary exercise testing (CPET) with respiratory gas analysis at the outpatient clinic. | Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention | |
Secondary | Change in the levels of physical activity | Daily physical activity (PA) is defined as the total number of daily low - intensity and high - intensity steps as measured objectively from a tri-axial accelerometer and subjectively through the use of the International Physical Activity Questionnaire. | 12 week follow - up (end of intervention), 6 months after the completion of the intervention | |
Secondary | Change in the Quality of participants' lives | Assessment of the participants' quality of life will be evaluated with the use of the Health Related Quality of Life questionnaire (HRQoL). | Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention | |
Secondary | Cost - effectiveness | The cost-effectiveness analysis will be performed using the assessment of Quality-adjusted life years (QALYs) as a utility measure. Patients will complete the European Quality of Life Five Dimension (EuroQol-5D) individually and their final scores will be converted into QALYs. The cost / benefit analysis will result from the calculation of the incremental cost-effectiveness ratio (ICER):
ICER = (cost intervention group - cost control group) / (effectiveness intervention group - effectiveness control group). Incremental cost refers to the difference, per patient, in the total average cost between the intervention groups and the control group. Incremental effectiveness was defined as the difference in the mean change in QALYs between the intervention group and the control group. |
12 week follow up | |
Secondary | Adherence to rehabilitation program | Patients' training adherence is defined as a percentage counted from the total number of completed training sessions. Patients' adherence in the telerehabilitation group will be evaluated through the Polar Flow web application as the overall completion rate of prescribed exercise sessions. Adherence in the centre - based cardiac rehabilitation group is determined as the number of attended training sessions at the outpatient clinic facilities, as recorded by the outpatient clinic's staff. | 12 week follow up | |
Secondary | Change in the levels of anxiety and depression | Anxiety and depression rates will be assessed through the Hospital Anxiety and Depression Scale (HADS) which has seven items for the depression subscale and seven items for the anxiety subscale. Scoring for each item ranges from zero(0) to three(3), with three(3) denoting highest anxiety or depression/anxiety level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression. | Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention | |
Secondary | Change in the smoking behaviour | Smoking cessation will be evaluated through the use of the fagerstrom Test for Nicotine Dependence(FTND). | Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention |
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