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Randomized parallel-group study to evaluate the impact of cardiac rehabilitation exercise management on improving exercise tolerance among patients with chronic heart disease using a telemetry-based biosignal measurement device
(iCARE-MATE study)

Randomized parallel-group study to evaluate the impact of cardiac rehabilitation exercise management on improving exercise tolerance among patients with chronic heart disease using a telemetry-based biosignal measurement device
(iCARE-MATE study)

Watanabe Takatomo

Gifu University Hospital

1-1 Yanagido, Gifu city, Gifu Pref., Japan

watanabe.takatomo.n6@f.gifu-u.ac.jp

Watanabe Takatomo

Gifu University Hospital

1-1 Yanagido, Gifu city, Gifu Pref., Japan

+81-58-230-6523

watanabe.takatomo.n6@f.gifu-u.ac.jp

Not Recruiting

July. 29, 2022

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

1. Outpatients who satisfy the general eligibility criteria for cardiac rehabilitation as outlined in the 2021 Japanese Circulation Society, Japanese Association of Cardiac Rehabilitation guidelines, including those with
a. Chronic heart failure defined by the presence of symptoms consistent with NYHA functional class I to III or elevated natriuretic peptides, BNP is more than 35 pg/mL or NT-proBNP is more than 125 pg/mL.
b. A history of acute myocardial infarction, angina pectoris, or open-heart surgery.
2. Patients who are 20 years of age or older at the time of obtaining consent
3. Patients who can give written consent to participate in this study
4. Patients whose percent peak VO2 is less than 80 percent

(1)Patients with difficulty in performing CPX and patients for whom PeakVO2 could not be measured
(2)Patients with heart failure symptoms NYHA3,4
(3)Patients who have difficulty putting on and taking off the wearable device
(4)Patients with dementia and patients with serious psychiatric disorders
(5)Other patients who are judged to be inappropriate as subjects by the principal investigator or investigators

Both

Chronic heart failure, ischemic heart disease and history of open heart surgery

After enrollment, study subjects will enter a 2- to 4-week pre-enrollment observation period and will undergo CPX at the end of the pre-enrollment period. Study subjects with a peak VO2 change of 3% or greater from pre-enrollment will be assigned to the device reference use group; study subjects with a peak VO2 change of less than 3% will be randomized in a 1:1 ratio to either the device use or no device use group. The device use group will receive exercise instruction based on the report at least once every 4 weeks.

chronic heart disease

wearable devices, exercise guidance

Change from baseline (at week 0) in Peak VO2 at 12 weeks after randomization

1. Within-group changes in peak VO2
a. From week 12 to 24 in the control group after crossover to the intervention.
b. From baseline to week 24 in the reference group.
2. Changes in clinical and physiological parameters from baseline to 12 and 24 weeks in both intervention and control groups
a. Blood biomarkers: BNP or NT-proBNP, renal function, lipid profile, hemoglobin A1c, troponin T, hemoglobin, and albumin.
b. Physical and anthropometric measures: body weight, body composition (measured via bioelectrical impedance analysis).
c. Echocardiographic findings (in selected centers), left ventricular ejection fraction, end-diastolic/systolic volume indices, diastolic function, and global longitudinal strain.
d. Autonomic nervous activity (in selected centers), assessed by heart rate variability (HRV) during a standing load test.
3. Patient-reported outcomes, evaluated at baseline, 12, and 24 weeks
a. Physical activity level, International Physical Activity Questionnaire (IPAQ).
b. Mental health, Hospital Anxiety and Depression Scale (HADS).
c. Cognitive function, Mini-Mental State Examination (MMSE).
4. Adherence and behavioral outcomes, measured via device-derived activity logs (daily steps, wear time), and therapist-recorded adherence to exercise recommendations.
5. Safety outcomes: frequency and nature of adverse events during the intervention and follow-up period.

+81-58-230-6059

July. 29, 2022

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