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Cardiac Telerehabilitation Effectiveness Using Wearable Sensors (TELE-WEAR)

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ClinicalTrials.gov Identifier: NCT05019157
Recruitment Status : Not yet recruiting
First Posted : August 24, 2021
Last Update Posted : August 24, 2021
Sponsor:
Information provided by (Responsible Party):
Garyfallia Pepera, University of Thessaly

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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Cardiac Rehabilitation Telerehabilitation Other: Telerehabilitation group Other: Centre - based rehabilitation group Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: supervised, randomised controlled trial
Masking: Single (Investigator)
Primary Purpose: Prevention
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
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Telerehabilitation group
Participants will undertake the first three training sessions in the outpatient clinic under the supervision of the specialized staff for familiarization with the intervention. and then the participants will proceed with the telerehabilitation program at their homes. Participants will undergo an exercise - based program 3 times/week, comprised of 10' warm up exercises, 40' aerobic, resistance and balance exercises and 10' cool down, with the use of wearable sensors.
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.

Active Comparator: 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 3 times/week, comprised of 10' warm up exercises, 40' aerobic, resistance and balance exercises and 10' cool down.
Other: 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.

No Intervention: Usual care group
Patients will not undertake any exercise based intervention and will only follow their usual medication treatment .The patients will wear the accelerometer for the 12 week study duration and visit the corresponding outpatient cardiac clinic every 4 weeks to upload the recorded data. The patients will also receive educational phone videoconference sessions every week for physical activity, diet/nutritional and smoking cessation counseling.



Primary Outcome Measures :
  1. Change in the levels of physical fitness [ Time Frame: Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention ]
    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.


Secondary Outcome Measures :
  1. Change in the levels of physical activity [ Time Frame: 12 week follow - up (end of intervention), 6 months after the completion of the intervention ]
    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.

  2. Change in the Quality of participants' lives [ Time Frame: Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention ]
    Assessment of the participants' quality of life will be evaluated with the use of the Health Related Quality of Life questionnaire (HRQoL).

  3. Cost - effectiveness [ Time Frame: 12 week follow up ]

    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.


  4. Adherence to rehabilitation program [ Time Frame: 12 week follow up ]
    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.

  5. Change in the levels of anxiety and depression [ Time Frame: Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention ]
    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.

  6. Change in the smoking behaviour [ Time Frame: Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention ]
    Smoking cessation will be evaluated through the use of the fagerstrom Test for Nicotine Dependence(FTND).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05019157


Contacts
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Contact: VARSAMO ANTONIOU, PhD student +306944635309 varsamoantoniou@uth.gr

Locations
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Greece
University of Thessaly
Lamia, Greece, 35100
Sponsors and Collaborators
Garyfallia Pepera
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Responsible Party: Garyfallia Pepera, Clinical Professor, University of Thessaly
ClinicalTrials.gov Identifier: NCT05019157    
Other Study ID Numbers: 364/01-06-2021
First Posted: August 24, 2021    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Garyfallia Pepera, University of Thessaly:
wearable sensors
exercise training
functional capacity
Additional relevant MeSH terms:
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Cardiovascular Diseases