Clinical trial NCT05873543: The Effect of a Smartphone-assisted Hybrid Cardiac Rehabilitation Program in Patients With Heart Failure.
Official title: The Effect of a Smartphone-assisted Hybrid Cardiac Rehabilitation Program in Patients With Heart Failure.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: cardiac rehabilitation
heart failure
eHealth
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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?


Eligibility criteria: 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.

Primary outcomes:
measure: Change of peak oxygen uptake
timeFrame: at baseline, 12 weeks(post-intervention), and 6 months.
measure: Change of 6 minute walking test
timeFrame: at baseline, 12 weeks(post-intervention), and 6 months.
Secondary outcomes:
measure: Adherence to prescribed exercise
timeFrame: 12 weeks(post-intervention)
measure: Evaluation of Quality of life
timeFrame: at baseline, 12 weeks(post-intervention), and 6 months.
measure: Depression
timeFrame: at baseline, 12 weeks(post-intervention), and 6 months.
measure: Anxiety
timeFrame: at baseline, 12 weeks(post-intervention), and 6 months.
measure: Evaluation of physical activity
timeFrame: at baseline, 12 weeks(post-intervention), and 6 months.
measure: Evaluation of grip strength
timeFrame: at baseline, 12 weeks(post-intervention), and 6 months.
measure: Evaluation of frailty
timeFrame: at baseline, 12 weeks(post-intervention), and 6 months.
measure: Blood test: Total cholesterol
timeFrame: at baseline, 12 weeks(post-intervention), and 6 months.
measure: Blood test: LDL
timeFrame: at baseline, 12 weeks(post-intervention), and 6 months.
measure: Blood test: HDL
timeFrame: at baseline, 12 weeks(post-intervention), and 6 months.
measure: Blood test: Triglyceride
timeFrame: at baseline, 12 weeks(post-intervention), and 6 months.
measure: Blood test: NT-proBNP
timeFrame: at baseline, 12 weeks(post-intervention), and 6 months.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
name: Hung-Jui Chuang, MD
role: PRINCIPAL_INVESTIGATOR
References: