Electronic Activity Tracking System (EATs)
Study Details
Study Description
Brief Summary
The intervention will involve a new system which comprises of a fitness tracker act as a medium to link to the healthcare system (i.e.: EATs) via a smartphone application. This is a new system comprising of a wrist-worn fitness tracker, smartphone application and internet/WiFi connectivity that link patients to healthcare professionals in a hospital setting.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Primary Objective: To determine the exercise capacity among patients with coronary heart disease (CHD) that utilising an electronic activity tracker system (EATs) during the cardiac rehabilitation phase 2 (CRP2).
Secondary Objectives: To assess the efficiency of EATs on patient's exercise adherence and identify the changes on the patient's cardiovascular risk factors, influence by the EATs utilisation.
Primary Endpoint: The patient's exercise capacity.
Secondary Endpoints: The patient's weekly exercise adherence; and cardiovascular risk factors include the serum lipid, blood pressure, body mass, body mass index (BMI), blood glucose level, and quality of life (QOL).
Study Population: Patient with coronary heart disease
Phase: 2
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 quantitative study consisting of a pilot study (phase 1) and a randomised control trial (phase 2). The present study will be conducting a single-blinded, three-arm, parallel over 8-weeks study period during CRP2. Measurement will be collected at pre- and post-test (8 weeks).
Study duration: 24 months
Participant Duration: 8 weeks
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Electronic Activity Tracking system (EATs) Receive the mHealth intervention by wearing activity tracker link with to the healthcare system with standard care |
Device: Fitness tracker
The participant is required to wear the fitness tracker every day during waking hours throughout the 8 weeks of intervention (except during sleeping, bathing, swimming).
Device: Auto-feedback/ reminder
The participant's data link to the healthcare system which provides with auto-feedback/ reminder.
Procedure: Standard care
Undergoing standard care by cardiac rehabilitation, UMMC
|
| Active Comparator: Fitness Tracker (FT) Receive the mHealth intervention by wearing activity tracker without the link to the healthcare system |
Device: Fitness tracker
The participant is required to wear the fitness tracker every day during waking hours throughout the 8 weeks of intervention (except during sleeping, bathing, swimming).
Procedure: Standard care
Undergoing standard care by cardiac rehabilitation, UMMC
|
| Placebo Comparator: Control (C) Standard care only |
Procedure: Standard care
Undergoing standard care by cardiac rehabilitation, UMMC
|
Outcome Measures
Primary Outcome Measures
- Exercise capacity (kcal/kg/hour) during exercise stress test [8 weeks]
Changes of metabolic equivalents (METs) from baseline and 8-weeks follow-up
Secondary Outcome Measures
- Gross volume oxygen (mL/kg/min) during exercise stress test [8 weeks]
Changes on the estimation of the gross volume oxygen from baseline and 8-weeks follow-up.
- Stage completed during exercise stress test [8 weeks]
Changes the stage completed from baseline and 8-weeks follow-up
- Total of exercise duration (minute) during exercise stress test [8 weeks]
Changes of total exercise duration from baseline and 8-weeks follow-up
- Resting heart rate (bpm) during exercise stress test [8 weeks]
Changes of resting heart rate from baseline and 8-weeks follow-up
- Heart rate reserve (bpm) during exercise stress test [8 weeks]
Heart rate reserve (HRR) is the difference between resting heart rate (HRrest) and maximum heart rate (HRmax). Changes of heart rate reserve is measured from baseline and 8-weeks follow-up.
- Total of day patient adherence to exercise [8 weeks]
Patient's weekly exercise adherence based on the UMfit applications' (apps) exercise history. The patient's exercise history is synchronised to our database and data can be assessed via UMFit portal. This is only applied for patient enrolling to the intervention group only. The exercise adherence in the control group will be assessed by using the weekly exercise log. The exercise adherence will be based on the individually prescription on their targeted frequency of the exercise, duration of the exercise and moderate exercise intensity (50-85% maximum heart rate) whether it is performed at the CR centre-based or home-based.
- Total cholesterol (mg/dL) [8 weeks]
Changes of serum lipid cholesterol from baseline and 8-weeks follow-up
- Triglyceride (mg/dL) [8 weeks]
Changes of serum lipid triglyceride from baseline and 8-weeks follow-up
- High-density lipoproteins (mg/dL) [8 weeks]
Changes of serum lipid high-density lipoproteins from baseline and 8-weeks follow-up
- Low-density lipoproteins (mg/dL) [8 weeks]
Changes of serum lipid low-density lipoproteins from baseline and 8-weeks follow-up
- Blood pressure (mm Hg) [8 weeks]
Changes of blood pressure from baseline, 4-weeks mid-intervention and 8-weeks follow-up
- Body mass (kg) [8 weeks]
Changes of body mass and BMI from baseline, 4-weeks mid-intervention and 8-weeks follow-up
- Body mass index (BMI) (kg/m^2) [8 weeks]
Changes of body mass and BMI from baseline, 4-weeks mid-intervention and 8-weeks follow-up
- Blood glucose level (mg/dL) [8 weeks]
Changes of glucose level from baseline and 8-weeks follow-up
- Haemoglobin A1C (HA1c) (mmol/mol) [8 weeks]
Changes of HA1c from baseline and 8-weeks follow-up. Depending on data availability.
- Quality of life (QOL) [8 weeks]
Changes QOL by using WHO Quality of Life-BREF (WHOQOL-BREF) from baseline and 8-weeks follow-up
Other Outcome Measures
- Assessment of patient perception and acceptance on the fitness tracker and smartphone apps [8 weeks]
Measured by using Technology Acceptance Model (TAM) questionnaire will be distributed to the intervention groups (EATs and FT groups) during 8-weeks follow-up
Eligibility Criteria
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 Phase 2 (CRP2);
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Low-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 at CR centre and at home with minimal supervision;
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The patient is willing to wear trackers during waking hours, own a personal smartphone and have access to internet/Wi-Fi; and
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Participant must be able to able to read, speak and understand English and Malay.
Exclusion Criteria:
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Heart failure NYHA Stage 3-4, pulse undetected by trackers;
-
The participant who cannot detect their pulse through wearable fitness tracker;
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Do not own a smartphone with the mobile internet; and
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Contraindicated for an exercise stress test and concomitant morbidity that limit physical activity and exercise.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rehabilitation Medicine, Pusat Perubatan Universiti Malaya | Kuala Lumpur | Malaysia | 59100 |
Sponsors and Collaborators
- University of Malaya
Investigators
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018112-6846
- RF009C-2018