Skip to main content
OpenTrials
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 Info

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital

Taipei, Taiwan

Location status: Recruiting

Location contact

Hung-Jui Chuang, MD

CONTACT

[email protected]

00886-2-23123456 ext. 67034

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)

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.

Primary outcomes

  1. 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.

  2. 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

  1. Adherence to prescribed exercise

    Time frame: 12 weeks(post-intervention)

    We will evaluate the percentage of completed prescribed exercises at 12 weeks.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Blood test: Total cholesterol

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

    The Total cholesterol will be tested in the laboratory.

  9. Blood test: LDL

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

    The LDL will be tested in the laboratory.

  10. Blood test: HDL

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

    The HDL will be tested in the laboratory.

  11. Blood test: Triglyceride

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

    The Triglyceride will be tested in the laboratory.

  12. 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.

Hung-Jui Chuang, MD

CONTACT

[email protected]

00886-2-23123456 ext. 67034

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.