Exercise-based Telerehabilitation in the Cardiac Rehabilitation Program

University of Malaya

Status: Completed

Conditions: Coronary Heart Disease

Treatments: Device: Exercise self-monitoring; Device: Exercise telemonitoring connects to healthcare platform; Procedure: Standard care; Procedure: Other CR components; Device: Exercise teleconsultation

Study type: Interventional

Funder types: Other

Identifiers

NCT04330560

2018112-6846

RF009C-2018 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 3 patient groups, including a placebo group

Ex group

Experimental group

Description:

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

Treatment:

Procedure: Other CR components

Device: Exercise teleconsultation

Device: Exercise telemonitoring connects to healthcare platform

Com group

Active Comparator group

Description:

Receive CR telerehabilitation (exercise self-monitoring + teleconsultation)

Treatment:

Procedure: Other CR components

Device: Exercise teleconsultation

Device: Exercise self-monitoring

C group

Placebo Comparator group

Description:

Standard care - traditional center-based CR

Treatment:

Procedure: Standard care