Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-29 @ 4:33 AM
Study NCT ID:
NCT05019157
Status:
UNKNOWN
Last Update Posted:
2021-08-24
First Post:
2021-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Telerehabilitation Effectiveness Using Wearable Sensors
Sponsor:
Garyfallia Pepera
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TELE-WEAR
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.
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: