The Effect of a Smartphone-assisted Hybrid Cardiac Rehabilitation Program in Patients With Heart Failure.

Heart Failure Clinical Trial

— SHCR-HF  

Official title:

The Effect of a Smartphone-assisted Hybrid Cardiac Rehabilitation Program in Patients With Heart Failure.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05873543
• Other study ID #: 202302009RINC
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: May 1, 2026

Study information

• Verified date: April 2023
• Source: National Taiwan University Hospital
• Contact: Hung-Jui Chuang, MD
• Phone: 00886-2-23123456
• Email: rexintwo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• smartphone-assisted hybrid cardiac rehabilitation (SHCR)
The 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.

Locations

Country	Name	City	State
Taiwan	Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of peak oxygen uptake	Peak oxygen uptake will be assessed using cardiopulmonary exercise test before intervention, at 12 weeks (post-intervention), and at 6 months.	at baseline, 12 weeks(post-intervention), and 6 months.
Primary	Change of 6 minute walking test	6 minute walking test will be performed before intervention, at 12 weeks (post-intervention), and at 6 months.	at baseline, 12 weeks(post-intervention), and 6 months.
Secondary	Adherence to prescribed exercise	We will evaluate the percentage of completed prescribed exercises at 12 weeks.	12 weeks(post-intervention)
Secondary	Evaluation of Quality of life	The investigators will assess the change in 36-Item Short Form Survey(SF-36).	at baseline, 12 weeks(post-intervention), and 6 months.
Secondary	Depression	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.	at baseline, 12 weeks(post-intervention), and 6 months.
Secondary	Anxiety	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.	at baseline, 12 weeks(post-intervention), and 6 months.
Secondary	Evaluation of physical activity	The investigators will assess the change in physical activity using International Physical Activity Questionnaire(IPAQ) Taiwan version.	at baseline, 12 weeks(post-intervention), and 6 months.
Secondary	Evaluation of grip strength	The grip strength will be measured using a grip goniometer with the participants seated and the elbow flexed at 90 degrees.	at baseline, 12 weeks(post-intervention), and 6 months.
Secondary	Evaluation of frailty	The investigators will evaluate the change in the Clinical Frailty Scale, which ranges from 1 to 9. Higher scores represent greater illness.	at baseline, 12 weeks(post-intervention), and 6 months.
Secondary	Blood test: Total cholesterol	The Total cholesterol will be tested in the laboratory.	at baseline, 12 weeks(post-intervention), and 6 months.
Secondary	Blood test: LDL	The LDL will be tested in the laboratory.	at baseline, 12 weeks(post-intervention), and 6 months.
Secondary	Blood test: HDL	The HDL will be tested in the laboratory.	at baseline, 12 weeks(post-intervention), and 6 months.
Secondary	Blood test: Triglyceride	The Triglyceride will be tested in the laboratory.	at baseline, 12 weeks(post-intervention), and 6 months.
Secondary	Blood test: NT-proBNP	The NT-proBNP will be tested in the laboratory.	at baseline, 12 weeks(post-intervention), and 6 months.