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

NCT05873543 | Recruiting

• 1 other identifier: 202302009RINC
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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. 1.Is the novel cardiac rehabilitation model feasible for patients with HF?
2. 2.Does the intervention group show a significant improvement in exercise capacity and adherence compared to the usual care group?

Conditions

Heart Failure

Keywords

cardiac rehabilitation; heart failure; eHealth

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Adherence to prescribed exercise

  12 weeks(post-intervention)

• Evaluation of Quality of life

  at baseline, 12 weeks(post-intervention), and 6 months.

• Depression

  at baseline, 12 weeks(post-intervention), and 6 months.

• Anxiety

  at baseline, 12 weeks(post-intervention), and 6 months.

• Evaluation of physical activity

  at baseline, 12 weeks(post-intervention), and 6 months.

Study Arms (2)

smartphone-assisted hybrid cardiac rehabilitation (SHCR)

EXPERIMENTAL

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)

Usual care

NO INTERVENTION

Participants receive usual care including general education and exercise suggestion.

Interventions

smartphone-assisted hybrid cardiac rehabilitation (SHCR) OTHER

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.

smartphone-assisted hybrid cardiac rehabilitation (SHCR)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Hung-Jui Chuang, MD

  Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hung-Jui Chuang, MD

CONTACT

00886-2-23123456; rexintwo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 24, 2023
• Study Start: January 26, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

TW (1)