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

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National Taiwan University

Status

Enrolling

Conditions

Heart Failure

Treatments

Other: smartphone-assisted hybrid cardiac rehabilitation (SHCR)

Study type

Interventional

Funder types

Other

Identifiers

NCT05873543
202302009RINC

Details and patient eligibility

About

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?

Enrollment

150 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

150 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Hung-Jui Chuang, MD

Data sourced from clinicaltrials.gov

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