Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-27 @ 11:08 PM
Study NCT ID:
NCT04330560
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2020-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise-based Telerehabilitation in the Cardiac Rehabilitation Program
Sponsor:
University of Malaya
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| RF009C-2018 | OTHER_GRANT | University of Malaya Grant | View |