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

Not Applicable

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT05873543
• Lead Sponsor: National Taiwan University Hospital

Brief 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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-01
• Study First Submitted QC: 2023-05-15
• Study First Posted: 2023-05-24
• Study Start: 2024-01-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-18
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of peak oxygen uptake	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	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 Outcome Measures

Name	Time	Method
Adherence to prescribed exercise	12 weeks(post-intervention)	We will evaluate the percentage of completed prescribed exercises at 12 weeks.
Depression	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.
Blood test: Triglyceride	at baseline, 12 weeks(post-intervention), and 6 months.	The Triglyceride will be tested in the laboratory.
Evaluation of Quality of life	at baseline, 12 weeks(post-intervention), and 6 months.	The investigators will assess the change in 36-Item Short Form Survey(SF-36).
Evaluation of physical activity	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.
Anxiety	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 grip strength	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.
Blood test: HDL	at baseline, 12 weeks(post-intervention), and 6 months.	The HDL will be tested in the laboratory.
Evaluation of frailty	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	at baseline, 12 weeks(post-intervention), and 6 months.	The Total cholesterol will be tested in the laboratory.
Blood test: LDL	at baseline, 12 weeks(post-intervention), and 6 months.	The LDL will be tested in the laboratory.
Blood test: NT-proBNP	at baseline, 12 weeks(post-intervention), and 6 months.	The NT-proBNP will be tested in the laboratory.

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan