Exercise-based Telerehabilitation in the Cardiac Rehabilitation Program
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
2 other identifiers
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2020
CompletedFirst Posted
Study publicly available on registry
April 1, 2020
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMay 8, 2024
May 1, 2024
6 months
February 25, 2020
May 7, 2024
Conditions
Outcome Measures
Primary Outcomes (8)
Feasibility (Recruitment procedure)
To inform the patient's acceptability towards recruitment procedure
12 weeks
Feasibility (Randomization procedure)
To inform the patient's acceptability towards randomization procedure
12 weeks
Feasibility (Cardiac rehabilitation program adherence)
To inform the patient's acceptability towards cardiac rehabilitation program adherence
12 weeks
Feasibility (Assessment adherence)
To inform the patient's acceptability towards assessment adherence
12 weeks
Feasibility (Safety - hospital readmission)
To inform the patient's safety on hospital readmission
12 weeks
Feasibility (Safety - cardiac adverse events)
To inform the patient's safety on cardiac adverse events
12 weeks
Exercise capacity during exercise stress test
Changes of metabolic equivalents (METs)
12 weeks
Exercise capacity during six-minutes walking test
Changes of walking distance (meter)
12 weeks
Secondary Outcomes (17)
Exercise adherence - Steps count
12 weeks
Exercise adherence - Exercise frequency
12 weeks
Exercise adherence - Exercise duration
12 weeks
Hospital readmission
12 weeks
Cardiac adverse events
12 weeks
- +12 more secondary outcomes
Study Arms (3)
Ex group
EXPERIMENTALReceive CR telerehabilitation (exercise telemonitoring link to the healthcare platform + teleconsultation)
Com group
ACTIVE COMPARATORReceive CR telerehabilitation (exercise self-monitoring + teleconsultation)
C group
PLACEBO COMPARATORStandard care - traditional center-based CR
Interventions
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
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.
Including dietary, psychology, education conducted at the center.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rehabilitation Medicine, Pusat Perubatan Universiti Malaya
Kuala Lumpur, 59100, Malaysia
Related Publications (1)
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.
PMID: 34741536DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anwar Suhaimi, MBBS
University of Malaya
- PRINCIPAL INVESTIGATOR
Wan Ling Lee, PhD
University of Malaya
- PRINCIPAL INVESTIGATOR
Sanjay Rampal Lekhraj Rampal, PhD
University of Malaya
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2020
First Posted
April 1, 2020
Study Start
December 1, 2020
Primary Completion
May 26, 2021
Study Completion
December 31, 2023
Last Updated
May 8, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share