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

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?

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: smartphone-assisted hybrid cardiac rehabilitation (SHCR)

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hung-Jui Chuang, MD; Phone Number: 67034 00886-2-23123456; Email: rexintwo@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
    • Contact: Hung-Jui Chuang, MD; Phone Number: 67034 00886-2-23123456; Email: rexintwo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: smartphone-assisted hybrid cardiac rehabilitation (SHCR); Participants receive a 12-wk case manager-led smartphone-assisted hybrid cardiac rehabilitation with follow-up at 12 week and 6 months.	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.
No Intervention: Usual care; Participants receive usual care including general education and exercise suggestion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to prescribed exercise	We will evaluate the percentage of completed prescribed exercises at 12 weeks.	12 weeks(post-intervention)
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.
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.
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.
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.
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.
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.
Blood test: Total cholesterol	The Total cholesterol will be tested in the laboratory.	at baseline, 12 weeks(post-intervention), and 6 months.
Blood test: LDL	The LDL will be tested in the laboratory.	at baseline, 12 weeks(post-intervention), and 6 months.
Blood test: HDL	The HDL will be tested in the laboratory.	at baseline, 12 weeks(post-intervention), and 6 months.
Blood test: Triglyceride	The Triglyceride will be tested in the laboratory.	at baseline, 12 weeks(post-intervention), and 6 months.
Blood test: NT-proBNP	The NT-proBNP will be tested in the laboratory.	at baseline, 12 weeks(post-intervention), and 6 months.

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Hung-Jui Chuang, MD, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 1, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: heart failure; eHealth; cardiac rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 202302009RINC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No