Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
Taipei, Taiwan
Location status: Recruiting
Recruiting
NCT Number: NCT05873543
The Effect of a Smartphone-assisted Hybrid Cardiac Rehabilitation Program in Patients With Heart Failure.
The aim of this randomized controlled trial is to compare the impact of a case manager-led smartphone-assisted hybrid cardiac rehabilitation program with usual care in patients with HF. Participants will undergo a 12-week program led by a case manager and assisted by a smartphone. The study aims to answer two main questions:
1. Is the novel cardiac rehabilitation model feasible for patients with HF? 2. Does the intervention group show a significant improvement in exercise capacity and adherence compared to the usual care group?
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients with heart failure between the ages of 18 and 80 years old.
- NYHA (New York Heart Association) functional classification of 1 to 3.
- Patients must be in a stable condition and under outpatient follow-up.
Exclusion criteria
- Patients who have contraindications for exercise according to the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription.
- Patients who are unable to complete cardiopulmonary exercise testing.
- Patients who are unable to follow verbal instructions.
- Patients who are unable to walk independently or pedal a stationary bicycle.
- Patients who are unable to use communication app on a smartphone.
- Patients who already engage in physical activity exceeding the recommended moderate intensity of 150 minutes per week or are currently participating in cardiac rehabilitation.
- Patients who do not provide consent to participate in the trial.
Treatment and study plan
smartphone-assisted hybrid cardiac rehabilitation (SHCR)
OtherThe 12-week case manager-led SHCR program includes:
- Customized exercise prescriptions following ACSM's heart failure guidelines.
- A hybrid program combining in-person sessions, home self-exercise, and videoconferencing for exercise coaching(optional), supported by a smartphone app.
- Case managers instruct patients on a communication app for weekly follow-ups, health education messages, exercise reminders, and progress tracking, including metrics like blood pressure, heart rate, weight, and symptoms.
Primary outcomes
-
Change of peak oxygen uptake
Time frame: at baseline, 12 weeks(post-intervention), and 6 months.
Peak oxygen uptake will be assessed using cardiopulmonary exercise test before intervention, at 12 weeks (post-intervention), and at 6 months.
-
Change of 6 minute walking test
Time frame: at baseline, 12 weeks(post-intervention), and 6 months.
6 minute walking test will be performed before intervention, at 12 weeks (post-intervention), and at 6 months.
Secondary outcomes
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Adherence to prescribed exercise
Time frame: 12 weeks(post-intervention)
We will evaluate the percentage of completed prescribed exercises at 12 weeks.
-
Evaluation of Quality of life
Time frame: at baseline, 12 weeks(post-intervention), and 6 months.
The investigators will assess the change in 36-Item Short Form Survey(SF-36).
-
Depression
Time frame: at baseline, 12 weeks(post-intervention), and 6 months.
The investigators will assess the change in Patient Health Questionnaire (PHQ-9). The PHQ-9 score ranges from 0-27. Higher scores indicate worsen symptoms.
-
Anxiety
Time frame: at baseline, 12 weeks(post-intervention), and 6 months.
The investigators will assess the change in Generalized Anxiety Disorder scale (GAD-7). The GAD-7 score ranges 0-21. Higher scores indicate worsen symptoms.
-
Evaluation of physical activity
Time frame: at baseline, 12 weeks(post-intervention), and 6 months.
The investigators will assess the change in physical activity using International Physical Activity Questionnaire(IPAQ) Taiwan version.
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Evaluation of grip strength
Time frame: at baseline, 12 weeks(post-intervention), and 6 months.
The grip strength will be measured using a grip goniometer with the participants seated and the elbow flexed at 90 degrees.
-
Evaluation of frailty
Time frame: at baseline, 12 weeks(post-intervention), and 6 months.
The investigators will evaluate the change in the Clinical Frailty Scale, which ranges from 1 to 9. Higher scores represent greater illness.
-
Blood test: Total cholesterol
Time frame: at baseline, 12 weeks(post-intervention), and 6 months.
The Total cholesterol will be tested in the laboratory.
-
Blood test: LDL
Time frame: at baseline, 12 weeks(post-intervention), and 6 months.
The LDL will be tested in the laboratory.
-
Blood test: HDL
Time frame: at baseline, 12 weeks(post-intervention), and 6 months.
The HDL will be tested in the laboratory.
-
Blood test: Triglyceride
Time frame: at baseline, 12 weeks(post-intervention), and 6 months.
The Triglyceride will be tested in the laboratory.
-
Blood test: NT-proBNP
Time frame: at baseline, 12 weeks(post-intervention), and 6 months.
The NT-proBNP will be tested in the laboratory.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
National Taiwan University Hospital
Other
Registry information
Acronym: SHCR-HF
Important dates
- Study start
- 2024
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- May 24, 2023
- Registry last updated
- Sep 29, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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