Cardiac Telerehabilitation Effectiveness Using Wearable Sensors

NCT05019157 | Unknown

• 1 other identifier: 364/01-06-2021
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Cardiac Rehabilitation; Telerehabilitation

Keywords

wearable sensors; exercise training; functional capacity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in the levels of physical activity

  12 week follow - up (end of intervention), 6 months after the completion of the intervention

• Change in the Quality of participants' lives

  Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention

• Cost - effectiveness

  12 week follow up

• Adherence to rehabilitation program

  12 week follow up

• Change in the levels of anxiety and depression

  Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention

Study Arms (3)

Telerehabilitation group

EXPERIMENTAL

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

Centre - based rehabilitation group

ACTIVE COMPARATOR

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

Usual care group

NO INTERVENTION

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.

Interventions

Telerehabilitation group OTHER

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.

Telerehabilitation group

Centre - based rehabilitation group OTHER

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.

Centre - based rehabilitation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Garyfallia Pepera: lead

Study Sites (1)

University of Thessaly

Lamia, 35100, Greece

Location

Related Publications (1)

• 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.

  PMID: 35738643 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

VARSAMO ANTONIOU, PhD student

CONTACT

+306944635309; varsamoantoniou@uth.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: supervised, randomised controlled trial

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 24, 2021
• Study Start: October 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: January 1, 2023
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)