An interventional study of exercise training for TechCR and audio/video conference in Coronary Heart Disease, sponsored by Chinese University of Hong Kong. Completed at 1 site in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Other
During this ongoing pandemic, there is a crucial need for innovative approaches to deliver CR programmes other than frequent face-to-face sessions at the centre-based CR to reduce the number of times people come close in contact with others or gathering in large groups. This is a single setting, 2-arm parallel randomised clinical trial which aims to examine the effects of technology-assisted interventions in hybrid cardiac rehabilitation (TecHCR) among the coronary heart disease patients. Eligible participants will be randomly assigned into either intervention group (IG) or control group (CG) in 1:1 ratio using the computerised permuted blocks, alternating block sizes of 4 or 6. All participants will be followed up for three months and six months with data collection at baseline, (T0), three-month (T1) and six-month (T2) time points.
In recent years, CR delivery platforms and approaches have been changing as technology has become an integral part of our daily lives. Some of the barriers to CR may be able to be tackled with the advancement of technology, as it provides an alternative to the traditional centre-based CR through virtual consultations and remote monitoring that may eliminate the hassle of face-to-face consultations, work and time conflicts. During this ongoing pandemic, there is a crucial need for innovative approaches to deliver CR programmes other than frequent face-to-face sessions at the centre-based CR to reduce the number of times people come close in contact with others or gathering in large groups.
The overall aim of this proposed study is to examine the effects of technology-assisted interventions in hybrid cardiac rehabilitation (TecHCR) among the coronary heart disease patients. The objectives are as followings:
With the attrition rate of 20%, a total of 160 eligible participants with 80 per group will be recruited. The control group receives usual care including outpatient medical follow-up with the cardiologists and dietician counselling before hospital discharge. Then, the participants will have their first follow-up by the physicians in cardiac rehabilitation clinic and followed by monthly follow-up. Subsequently, they will have weekly, centre-based supervised exercise training by physiotherapist and follow-up with occupational therapist for 12 weeks. In addition of the usual care of outpatient medical follow-ups and dietary education, the intervention group will receive 3 times supervised exercise in the centre, weekly upload of CR education (audio-visual video) on WhatsApp for six weeks (Week 1 to Week 6). The prescribed exercise will then be continued at home with a pedometer as the "cue to action" to be worn by the participant; he or she will be required to upload the data daily to the web app on the smartphone. Participants will also receive a weekly audio/video-conferencing follow-up (Week 1 to Week 12). The outcome measures include Socio-demographic and Clinical Data, Bandura's exercise self efficacy scale (ESE), Health Promoting Lifestyle Profile II (HPLP II), adherence referring to the attendance to 12 weeks (supervised exercise training) for CG, and attendance (3 times supervised exercise training) and upload of exercise data (for 9 weeks) to web app for IG; and 12-week assessment for both groups, exercise capacity by Exercise Stress Test measuring the metabolic equivalents METs) and Hospital Anxiety and Depression Scale (HADS). The data entry and analysis will be performed using the IBM Social Package Statistical Software (SPSS) version 26.0 with a p value \< 0.05 will be consider significant of the result.
2,867 studies on the registry are indexed under Coronary Disease; 309 are open to participants now.
This study's enrollment of 160 is above the median of 124 across 1,601 interventional studies indexed under Coronary Disease.
Browse Coronary Disease studies →Chinese University of Hong Kong is the lead sponsor of 1,446 studies on the registry; 467 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
12 weeks Hybrid between supervised exercise training and video call sessions Educational videos Dietary and exercise log
Behavioral: exercise training for TechCR · Behavioral: audio/video conference · Behavioral: educational video · Behavioral: Daily log
12 weeks usual care provided by the centre-based, outpatient cardiac rehabilitation clinic Dietary and exercise log
Behavioral: Daily log · Behavioral: exercise training for centre-based
3 times of supervised exercise training at the centre-based, outpatient cardiac rehabilitation clinic
weekly audio/video conference
weekly for 6 weeks, duration of video about 10-15 minutes
daily dietary and exercise log
6 times of supervised exercise training
self-efficacy related to exercise (Bandura's Exercise Self-efficacy)
Using Bandura's Exercise Self-efficacy to determine the effects of TecHCR on self-efficacy related to exercise before intervention (baseline)
Time frame: Baseline (T0) - at 0 week, before initiation of interventions
self-efficacy related to exercise (Bandura's Exercise Self-efficacy)
Using Bandura's Exercise Self-efficacy to determine the effects of TecHCR on self-efficacy related to exercise post intervention (at 3-month)
Time frame: post intervention (T1) - at 12 weeks after initiation of interventions
self-efficacy related to exercise (Bandura's Exercise Self-efficacy)
Using Bandura's Exercise Self-efficacy to determine the effects of TecHCR on self-efficacy related to exercise 3-month post intervention (T2) (at 6 month)
Time frame: 6-month post intervention (T2) - at 36 weeks after initiation of interventions
behavioural outcomes (Health-promoting Lifestyle Profile II)
Using Health-promoting lifestyle Profile II to determine the effects of TecHCR on health promoting behaviours
Time frame: Baseline (T0) - at 0 week, before initiation of interventions
behavioural outcomes (Health-promoting Lifestyle Profile II)
Using Health-promoting lifestyle Profile II to determine the effects of TecHCR on health promoting behaviours
Time frame: post intervention (T1) - at 12 weeks after initiation of interventions
behavioural outcomes (Health-promoting Lifestyle Profile II)
Using Health-promoting lifestyle Profile II to determine the effects of TecHCR on health promoting behaviours
Time frame: 6-month post intervention (T2) - at 36 weeks after initiation of interventions
psychological outcomes (Hospital Anxiety and Depression Scale)
Using Hospital Anxiety and Depression Scale to determine the effects of TecHCR on anxiety and depression
Time frame: Baseline (T0) - at 0 week, before initiation of interventions
psychological outcomes (Hospital Anxiety and Depression Scale)
Using Hospital Anxiety and Depression Scale to determine the effects of TecHCR on anxiety and depression
Time frame: post intervention (T1) - at 12 weeks after initiation of interventions
psychological outcomes (Hospital Anxiety and Depression Scale)
Using Hospital Anxiety and Depression Scale to determine the effects of TecHCR on anxiety and depression
Time frame: 6-month post intervention (T2) - at 36 weeks after initiation of interventions
fasting low density lipoprotein (LDL), high density lipoprotein (HDL), total cholesterol (from laboratory blood test result)
to determine the effects of TecHCR on fasting low density lipoprotein (LDL), high density lipoprotein (HDL), total cholesterol (mmol/L)
Time frame: Baseline (T0) - at 0 week, before initiation of interventions
fasting low density lipoprotein (LDL), high density lipoprotein (HDL), total cholesterol (from laboratory blood test result)
to determine the effects of TecHCR on fasting low density lipoprotein (LDL), high density lipoprotein (HDL), total cholesterol (mmol/L)
Time frame: post intervention (T1) - at 12 weeks after initiation of interventions
fasting low density lipoprotein (LDL), high density lipoprotein (HDL), total cholesterol (from laboratory blood test result)
to determine the effects of TecHCR on fasting low density lipoprotein (LDL), high density lipoprotein (HDL), total cholesterol (mmol/L)
Time frame: 6-month post intervention (T2) - at 36 weeks after initiation of interventions
systolic and diastolic blood pressure (using blood pressure monitoring device)
to determine the effects of TecHCR on systolic and diastolic blood pressure
Time frame: Baseline (T0) - at 0 week, before initiation of interventions
systolic and diastolic blood pressure (using blood pressure monitoring device)
to determine the effects of TecHCR on systolic and diastolic blood pressure
Time frame: post intervention (T1) - at 12 weeks after initiation of interventions
systolic and diastolic blood pressure (using blood pressure monitoring device)
to determine the effects of TecHCR on systolic and diastolic blood pressure
Time frame: 6-month post intervention (T2) - at 36 weeks after initiation of interventions
Body Mass Index (BMI) (weight in kilogrammes*height in metres^2)
to determine the effects of TecHCR on BMI
Time frame: Baseline (T0) - at 0 week, before initiation of interventions
Body Mass Index (BMI) (weight in kilogrammes*height in metres^2)
to determine the effects of TecHCR on BMI
Time frame: post intervention (T1) - at 12 weeks after initiation of interventions
Body Mass Index (BMI) (weight in kilogrammes*height in metres^2)
to determine the effects of TecHCR on BMI
Time frame: 6-month post intervention (T2) - at 36 weeks after initiation of interventions
Waist circumference (measured by measuring tape in centimetres)
to determine the effects of TecHCR on waist circumference
Time frame: Baseline (T0) - at 0 week, before initiation of interventions
Waist circumference (measured by measuring tape in centimetres)
to determine the effects of TecHCR on waist circumference
Time frame: post intervention (T1) - at 12 weeks after initiation of interventions
Waist circumference (measured by measuring tape in centimetres)
to determine the effects of TecHCR on waist circumference
Time frame: 6-month post intervention (T2) - at 36 weeks after initiation of interventions
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Chinese University of Hong Kong →