Impact of Online Support of Physical Activity Management Using a Wearable Device on Renal Function in Patients with Acute Coronary Syndrome

JRCT ID: jRCT1022240014

Registered date:05/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute coronary syndrome
• Date of first enrollment: 08/05/2024
• Target sample size: 88
• Study type: Interventional

Intervention(s)

Intervention group (online support of physical activity management)
The online support of physical activity management in this study will be implemented for 3 months starting at the time of discharge from the hospital. Patients in the intervention group will manage their own physical activity based on educational support by a physical therapist. Patients in the intervention group will receive a wrist-worn wearable device (Fitbit Inspire 3) after assignment, and at the same time, they will download the physical activity management application software, Recaval (Saplim, Inc.) to their smartphones. The patient's physical activity data and pulse rate data obtained from the wearable device will be transmitted in real time via the app to the tablet device of the physical therapist in charge of the research facility. Patients will be instructed to wear the wearable device when not bathing or charging the device. In addition, patients will be instructed to enter their daily blood pressure and subjective symptom self-records on the app, which will also be monitored daily by the physical therapist.
At the beginning of the intervention and every two weeks thereafter, the physical therapist provides a summary report of daily vital sign data to the patient on the app, along with educational comments and praise for each patient's physical activity and activity pulse rate goals and achievement of those goals.

Outcome(s)

• Primary Outcome: estimated glomerular filtration rate calculated by serum cystatin C (eGFRcys)
• Secondary Outcome: Urine albumin/creatinine ratio, brain natriuretic peptide, average number of steps, peak oxygen uptake, quality of life (EQ-5D), and incidence of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Age 18 years or older at the time of consent
2) Patients who developed ACS and underwent percutaneous coronary angioplasty and inpatient cardiac rehabilitation
3) Patients who have difficulty participating in outpatient cardiac rehabilitation after discharge from the hospital
4) Patients who have a smartphone
5) Patients who agreed to participate in this study

Exclude criteria

1) Patients who are not independent in daily living
2) Patients with unstable angina pectoris
3) Patients with uncontrolled arrhythmia causing hemodynamic abnormalities
4) Patients with severe valvular heart disease
5) Patients with uncontrolled diabetes mellitus
6) Patients with other diseases that contraindicate the use of exercise therapy
7) Patients on dialysis
8) Patients with complications of other acute diseases or indications for surgical treatment
9) Patients with dementia
10) Patients who have difficulty in receiving regular outpatient visits at the facility after discharge from the hospital

Related Information

• Primary Sponsor: Sato Toshimi
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology (MEXT)