Recruiting NCT05873543
The Effect of a Smartphone-assisted Hybrid Cardiac Rehabilitation Program in Patients With Heart Failure.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: smartphone-assisted hybrid cardiac rehabilitation (SHCR).
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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?
Interventions
- 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
Primary outcome measures
- Change of peak oxygen uptake [Time frame: 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.]
Secondary outcome measures (12)
- Adherence to prescribed exercise [Time frame: 12 weeks(post-intervention)]
- Evaluation of Quality of life [Time frame: at baseline, 12 weeks(post-intervention), and 6 months.]
- Depression [Time frame: at baseline, 12 weeks(post-intervention), and 6 months.]
- Anxiety [Time frame: at baseline, 12 weeks(post-intervention), and 6 months.]
- Evaluation of physical activity [Time frame: at baseline, 12 weeks(post-intervention), and 6 months.]
- Evaluation of grip strength [Time frame: at baseline, 12 weeks(post-intervention), and 6 months.]
- Evaluation of frailty [Time frame: at baseline, 12 weeks(post-intervention), and 6 months.]
- Blood test: Total cholesterol [Time frame: at baseline, 12 weeks(post-intervention), and 6 months.]
- Blood test: LDL [Time frame: at baseline, 12 weeks(post-intervention), and 6 months.]
- Blood test: HDL [Time frame: at baseline, 12 weeks(post-intervention), and 6 months.]
- Blood test: Triglyceride [Time frame: at baseline, 12 weeks(post-intervention), and 6 months.]
- Blood test: NT-proBNP [Time frame: at baseline, 12 weeks(post-intervention), and 6 months.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT05873543 · 202302009RINC