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

September 23, 2025 updated by: National Taiwan University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
at baseline, 12 weeks(post-intervention), and 6 months.
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.
at baseline, 12 weeks(post-intervention), and 6 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adherence to prescribed exercise
Time Frame: 12 weeks(post-intervention)
We will evaluate the percentage of completed prescribed exercises at 12 weeks.
12 weeks(post-intervention)
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).
at baseline, 12 weeks(post-intervention), and 6 months.
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.
at baseline, 12 weeks(post-intervention), and 6 months.
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.
at baseline, 12 weeks(post-intervention), and 6 months.
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.
at baseline, 12 weeks(post-intervention), and 6 months.
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.
at baseline, 12 weeks(post-intervention), and 6 months.
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.
at baseline, 12 weeks(post-intervention), and 6 months.
Blood test: Total cholesterol
Time Frame: at baseline, 12 weeks(post-intervention), and 6 months.
The Total cholesterol will be tested in the laboratory.
at baseline, 12 weeks(post-intervention), and 6 months.
Blood test: LDL
Time Frame: at baseline, 12 weeks(post-intervention), and 6 months.
The LDL will be tested in the laboratory.
at baseline, 12 weeks(post-intervention), and 6 months.
Blood test: HDL
Time Frame: at baseline, 12 weeks(post-intervention), and 6 months.
The HDL will be tested in the laboratory.
at baseline, 12 weeks(post-intervention), and 6 months.
Blood test: Triglyceride
Time Frame: at baseline, 12 weeks(post-intervention), and 6 months.
The Triglyceride will be tested in the laboratory.
at baseline, 12 weeks(post-intervention), and 6 months.
Blood test: NT-proBNP
Time Frame: at baseline, 12 weeks(post-intervention), and 6 months.
The NT-proBNP will be tested in the laboratory.
at baseline, 12 weeks(post-intervention), and 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hung-Jui Chuang, MD, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 26, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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