Clinical trial NCT04330560: Exercise-based Telerehabilitation in the Cardiac Rehabilitation Program
Official title: Feasibility and Preliminary Evaluation and the Effects of Exercise-based Telerehabilitation on the Acceptability and Safety, and Clinical Effectiveness Among Patients With Coronary Heart Disease Undergoing the Cardiac Rehabilitation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility (Recruitment procedure)
timeFrame: 12 weeks
measure: Feasibility (Randomization procedure)
timeFrame: 12 weeks
measure: Feasibility (Cardiac rehabilitation program adherence)
timeFrame: 12 weeks
measure: Feasibility (Assessment adherence)
timeFrame: 12 weeks
measure: Feasibility (Safety - hospital readmission)
timeFrame: 12 weeks
measure: Feasibility (Safety - cardiac adverse events)
timeFrame: 12 weeks
measure: Exercise capacity during exercise stress test
timeFrame: 12 weeks
measure: Exercise capacity during six-minutes walking test
timeFrame: 12 weeks
Secondary outcomes:
measure: Exercise adherence - Steps count
timeFrame: 12 weeks
measure: Exercise adherence - Exercise frequency
timeFrame: 12 weeks
measure: Exercise adherence - Exercise duration
timeFrame: 12 weeks
measure: Hospital readmission
timeFrame: 12 weeks
measure: Cardiac adverse events
timeFrame: 12 weeks
measure: Blood collection - serum cholesterol
timeFrame: 12 weeks
measure: Blood collection - triglyceride
timeFrame: 12 weeks
measure: Blood collection - high-density lipoproteins (HDL)
timeFrame: 12 weeks
measure: Blood collection - low-density lipoprotein (LDL)
timeFrame: 12 weeks
measure: Blood collection - Haemoglobin A1C (HA1c)
timeFrame: 12 weeks
measure: Body mass (kg)
timeFrame: 12 weeks
measure: Body mass index (BMI) (kg/m2)
timeFrame: 12 weeks
measure: Usability scale score
timeFrame: 12 weeks
measure: Factors associated with non-adherence to cardiac rehabilitation program score
timeFrame: 12 weeks
measure: Quality of life (QOL) score
timeFrame: 12 weeks
measure: Fitness tracker acceptance score
timeFrame: 12 weeks
measure: Participant's acceptance to the exercise-based telemonitoring
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Rehabilitation Medicine, Pusat Perubatan Universiti Malaya
Study officials:
affiliation: University of Malaya
name: Anwar Suhaimi, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malaya
name: Wan Ling Lee, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malaya
name: Sanjay Rampal Lekhraj Rampal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.