Exercise-based Telerehabilitation in the Cardiac Rehabilitation Program
NCT ID: NCT04330560
Last Updated: 2024-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2020-12-01
2023-12-31
Brief Summary
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Detailed Description
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Randomized control trial objective: -
1. Primary Objective: To determine the exercise capacity among patients with CHD,
2. Secondary Objectives: To assess patient exercise adherence and determine the changes in other clinical health outcomes.
Study Population: Patients with coronary heart disease
Description of Sites/Facilities Enrolling Participants: Patient engagement with the cardiac rehabilitation phase 2 (CRP2) at the University Malaya Medical Centre (UMMC).
Description of Study Intervention: This study is a mixed-methods study consisting of a quantitative study (feasibility, preliminary evaluation, and full randomized control trial) and a qualitative study (interviewing). The present study will be conducting a single-blinded, three-arm, parallel over a 12-weeks study period during CRP2. Measurement will be collected during pre-and post-test.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ex group
Receive CR telerehabilitation (exercise telemonitoring link to the healthcare platform + teleconsultation)
Exercise telemonitoring connects to healthcare platform
The participant is required to wear the fitness tracker every day during waking hours throughout the 12 weeks of intervention (except during sleeping, bathing, and swimming) link to the healthcare practitioner
Exercise teleconsultation
Conducted through smartphone video call app.
Other CR components
Including dietary, psychology, education conducted at the center.
Com group
Receive CR telerehabilitation (exercise self-monitoring + teleconsultation)
Exercise self-monitoring
The participant is required to wear the fitness tracker every day during waking hours throughout the 12 weeks of intervention (except during sleeping, bathing, and swimming) for exercise self-monitoring.
Exercise teleconsultation
Conducted through smartphone video call app.
Other CR components
Including dietary, psychology, education conducted at the center.
C group
Standard care - traditional center-based CR
Standard care
Undergoing standard care by cardiac rehabilitation at the center
Interventions
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Exercise telemonitoring connects to healthcare platform
The participant is required to wear the fitness tracker every day during waking hours throughout the 12 weeks of intervention (except during sleeping, bathing, and swimming) link to the healthcare practitioner
Exercise self-monitoring
The participant is required to wear the fitness tracker every day during waking hours throughout the 12 weeks of intervention (except during sleeping, bathing, and swimming) for exercise self-monitoring.
Exercise teleconsultation
Conducted through smartphone video call app.
Other CR components
Including dietary, psychology, education conducted at the center.
Standard care
Undergoing standard care by cardiac rehabilitation at the center
Eligibility Criteria
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Inclusion Criteria
* Low- and moderate-risk patient category (controlled BP, sinus rhythm at 60-90 bpm, pain score\< 3/10) and received a statement of medical clearance by a CR physician to undertake exercise with minimal supervision;
* The patient is willing to wear trackers during waking hours, own a personal smartphone and have access to internet/Wi-Fi; and
* Participant must be able to able to read, speak and understand English and Malay.
Exclusion Criteria
* The participant who cannot detect their pulse through wrist-worn tracker;
* Do not own a smartphone with the mobile internet/Wi-Fi ; and
* Contraindicated for an exercise stress test and concomitant morbidity that limit physical activity and exercise.
18 Years
ALL
No
Sponsors
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University of Malaya
OTHER
Responsible Party
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Principal Investigators
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Anwar Suhaimi, MBBS
Role: PRINCIPAL_INVESTIGATOR
University of Malaya
Wan Ling Lee, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Malaya
Sanjay Rampal Lekhraj Rampal, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Malaya
Locations
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Rehabilitation Medicine, Pusat Perubatan Universiti Malaya
Kuala Lumpur, , Malaysia
Countries
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References
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Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.
Other Identifiers
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RF009C-2018
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2018112-6846
Identifier Type: -
Identifier Source: org_study_id
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