Clinical trial NCT05019157: Cardiac Telerehabilitation Effectiveness Using Wearable Sensors
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Cardiac Rehabilitation
Telerehabilitation
Keywords: wearable sensors
exercise training
functional capacity
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: supervised, randomised controlled trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Methods Research design

A supervised, single - blind, randomized controlled trial design will be used to examine the efficacy, efficiency and cost - effectiveness of a cardiac telerehabilitation program using wearable sensors. The study was approved by the ethics committee of University of Thessaly.

Sample One hundred and two (102) cardiac patients will be recruited from cardiac rehabilitation centres. Subject eligibility criteria are: a) 18 years of age and older b) diagnosis of stable cardiovascular diseases, acute coronary syndrome, coronary artery bypass grafting within the previous six months c) ability to perform physical exercise d) ability to understand and write in the Greek language e) possession of a mobile smartphone and access to internet facilities.

Assessments Study data will be collected at baseline, the completion of the intervention period (12 weeks follow - up) and 6 months after the completion of the intervention (long - term follow - up)

Procedure

The telerehabilitation group will undergo a telemonitored exercise - based rehabilitation program 3 days a week for 12 consecutive weeks for 60'/session. The centre - based rehabilitation group will undertake a supervised exercise - based rehabilitation program 3 days a week for 12 consecutive weeks for 60'/session at the rehabilitation centres' facilities. The control group will not receive any exercise intervention during that period.

Outcome measures Functional ability, as the primary outcome of the study, will be assessed at baseline, at 12 weeks and 6 months after the completion of the intervention (long - term follow - up) via cardiopulmonary exercise testing.

Physical activity will be recorded and evaluated at the 12 weeks follow up andn the long - term follow - up by the use of tri - axial accelerometer and the International Physical Activity Questionnaire (IPAQ).

Quality of life will be assessed at baseline, at 12 weeks and 6 months after the completion of the intervention (long - term follow - up) by the use of Health related quality of life Questionnaire(HRQoL).

Anxiety levels and smoking cessation will be evaluated at baseline, at 12 weeks and 6 months after the completion of the intervention (long - term follow - up) through the use of the Hospital Anxiety and Depression scale (HADS) and the fagerstrom Test for Nicotine Dependence (FTND) respectively.

Training adherence will be evaluated during the 12 week assessment endpoint, taking in account the total number of successfully completed training sessions.

The cost-effectiveness analysis will be performed using the assessment of Quality-adjusted life years (QALYs) as a utility measure, obtained with the EuroQol-5D questionnaire at baseline and 12 - weeks follow - up assessment

Eligibility criteria: 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

Primary outcomes:
measure: Change in the levels of physical fitness
timeFrame: Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention
Secondary outcomes:
measure: Change in the levels of physical activity
timeFrame: 12 week follow - up (end of intervention), 6 months after the completion of the intervention
measure: Change in the Quality of participants' lives
timeFrame: Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention
measure: Cost - effectiveness
timeFrame: 12 week follow up
measure: Adherence to rehabilitation program
timeFrame: 12 week follow up
measure: Change in the levels of anxiety and depression
timeFrame: Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention
measure: Change in the smoking behaviour
timeFrame: Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention
Other outcomes:
Locations:
city: Lamia
country: Greece
facility: University of Thessaly
Study officials:
References:
citation: Antoniou V, Xanthopoulos A, Giamouzis G, Davos C, Batalik L, Stavrou V, Gourgoulianis KI, Kapreli E, Skoularigis J, Pepera G. Efficacy, efficiency and safety of a cardiac telerehabilitation programme using wearable sensors in patients with coronary heart disease: the TELEWEAR-CR study protocol. BMJ Open. 2022 Jun 23;12(6):e059945. doi: 10.1136/bmjopen-2021-059945.