Exercise-based Telerehabilitation in the Cardiac Rehabilitation Program

NCT ID: NCT04330560

Last Updated: 2024-05-08

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2023-12-31

Brief Summary

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The intervention will involve a system that comprises a wrist-worn activity tracker and a smartphone app that acts as a medium to link to the healthcare website

Detailed Description

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Feasibility study objective: - To investigate the feasibility and preliminary of exercise-based telerehabilitation before undertaking full-scale RCT.

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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Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
The masking will be imposed on the investigator who will be involved with the recruitment of the participant to prevent selection bias. The allocation of the participant to a group will be randomised using computer-generated random numbers by the other investigator who did not involve in recruiting the participant.

Study Groups

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Ex group

Receive CR telerehabilitation (exercise telemonitoring link to the healthcare platform + teleconsultation)

Group Type EXPERIMENTAL

Exercise telemonitoring connects to healthcare platform

Intervention Type DEVICE

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

Intervention Type DEVICE

Conducted through smartphone video call app.

Other CR components

Intervention Type PROCEDURE

Including dietary, psychology, education conducted at the center.

Com group

Receive CR telerehabilitation (exercise self-monitoring + teleconsultation)

Group Type ACTIVE_COMPARATOR

Exercise self-monitoring

Intervention Type DEVICE

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

Intervention Type DEVICE

Conducted through smartphone video call app.

Other CR components

Intervention Type PROCEDURE

Including dietary, psychology, education conducted at the center.

C group

Standard care - traditional center-based CR

Group Type PLACEBO_COMPARATOR

Standard care

Intervention Type PROCEDURE

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

Intervention Type DEVICE

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.

Intervention Type DEVICE

Exercise teleconsultation

Conducted through smartphone video call app.

Intervention Type DEVICE

Other CR components

Including dietary, psychology, education conducted at the center.

Intervention Type PROCEDURE

Standard care

Undergoing standard care by cardiac rehabilitation at the center

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adults with 18 years old and above with indexed diagnosis of coronary heart disease (CHD) and are referred for Cardiac Rehabilitation Program;
* 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

* Heart failure NYHA Stage 3-4, pulse undetected by trackers;
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Malaysia

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.

Reference Type DERIVED
PMID: 34741536 (View on PubMed)

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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