Cardiac Telerehabilitation Effectiveness Using Wearable Sensors

Cardiovascular Diseases Clinical Trial

— TELE-WEAR  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05019157
• Other study ID #: 364/01-06-2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2021
• Est. completion date: January 2023

Study information

• Verified date: August 2021
• Source: University of Thessaly
• Contact: VARSAMO ANTONIOU, PhD student
• Phone: +306944635309
• Email: varsamoantoniou[@]uth.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cardiac Rehabilitation
• Cardiovascular Diseases
• Telerehabilitation

Intervention

Other:
• Telerehabilitation group
Participants will undertake the first three training sessions in the outpatient clinic for familiarization with the training modalities, the wearable sensors and the data uploading. Afterwards, the participants will proceed with the telerehabilitation program at their homes. The participants will be lent the wearable sensors and will undergo an exercise - based program 3 times/week, comprising of 10' warm up exercises, 40' aerobic, resistance, balance exercises and 10' cool down.Training sessions will be monitored, in real time, by the study investigator. Participants should upload the recorded data to Polar Flow web platform after every training session and should visit the outpatient clinic every month to upload the accelerometry's recorded data to a secure personal computer) application. Educational and informational videoconferences will be held every week for upright training exercise sessions, physical activity counseling, diet/nutritional and smoking cessation counseling.
• Centre - based rehabilitation group
Participants will attend an exercise - based cardiac rehabilitation program at the outpatient clinic's facilities under the supervision of cardiac rehabilitation specialized staff. The participants will receive an individually tailored training program on a treadmill or a cycle ergometer. Total training attendance rate will be documented by the cardiac rehabilitation centre staff. Patients will be instructed to wear a tri - axial accelerometer during the entire 12 weeks study period. Participants should upload recorded data to the local server every month. Educational videoconferences will be held every week for physical activity counseling, diet/nutritional and smoking cessation counseling.

Locations

Country	Name	City	State
Greece	University of Thessaly	Lamia

Sponsors (1)

Lead Sponsor	Collaborator
Garyfallia Pepera

Country where clinical trial is conducted

Greece, 

Outcome

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