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

JRCT ID: jRCT1042220058

Registered date:26/08/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Chronic heart failure, ischemic heart disease and history of open heart surgery
• Date of first enrollment: 01/09/2022
• Target sample size: 170
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Change from baseline (at week 0) in Peak VO2 at 12 weeks after randomization

Secondary Outcome

(1)Difference in change in Peak VO2 with and without device in the device-naive group
(2)Difference in change in Peak VO2 between 4 and 24 weeks after enrollment and during the previous observation period in the device reference group
(3)Change in blood test findings between baseline and 12 and 24 weeks in the device use and non-use groups
(4)Change in general findings and anthropometric data between baseline and 12 and 24 weeks in the device-used and device-unused groups
(5)Changes in questionnaire results between baseline and 12 and 24 weeks in the device-used and device-unused groups

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable

Include criteria

(1) Patients with a history of chronic heart failure, acute myocardial infarction, angina pectoris, or open heart surgery who are outpatients
(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 %peak VO2 is less than 80%

Exclude criteria

(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

Related Information

• Primary Sponsor: Watanabe Takatomo
• Source(s) of Monetary Support: TOKAI Corp.