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

NCT ID: NCT05873543

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-26

Study Completion Date

2028-12-01

Brief Summary

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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

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

smartphone-assisted hybrid cardiac rehabilitation (SHCR)

Intervention Type 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.

Usual care

Participants receive usual care including general education and exercise suggestion.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hung-Jui Chuang, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital

Locations

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Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hung-Jui Chuang, MD

Role: CONTACT

00886-2-23123456 ext. 67034

Facility Contacts

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Hung-Jui Chuang, MD

Role: primary

00886-2-23123456 ext. 67034

Other Identifiers

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202302009RINC

Identifier Type: -

Identifier Source: org_study_id

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