None listed
Conditions
Interventions
Medical Device : This study is a randomized sham-controlled crossover trial designed to evaluate the physiological effects of an automated electric massage device in middle-aged adults. Participants w
Sponsors
Daejeon University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 40 to 64 years 2. Individuals who understand the purpose and procedures of the study and voluntarily provide written informed consent 3. Individuals who are able to participate in the study procedures, including massage intervention, low-intensity muscle stimulation, blood pressure measurement, heart rate variability assessment, continuous glucose monitoring, and oral glucose tolerance testing 4. Individuals who are able to comply with the scheduled study visits and procedures during the study period 5. Individuals without serious medical conditions that may interfere with study participation, as determined by the investigator 6. Individuals who are medically eligible to undergo autonomic nervous system measurements (HRV), blood pressure monitoring, and glucose measurements (CGM and OGTT)
Exclusion criteria
Exclusion criteria: 1. Adults younger than 40 years or older than 64 years 2. Individuals who are unable to understand the study procedures or provide voluntary informed consent 3. History of major cardiovascular diseases within the past 6 months, including myocardial infarction, stroke, or unstable angina 4. Presence of arrhythmia or use of a pacemaker that may significantly affect heart rate variability measurements 5. Uncontrolled hypertension (SBP =160 mmHg or DBP =100 mmHg) 6. Individuals currently receiving treatment for diabetes mellitus, including insulin therapy, or those for whom an oral glucose tolerance test is clinically inappropriate 7. Musculoskeletal or neurological conditions, recent surgery, or severe pain that limits the ability to perform low-intensity resistance exercise 8. Skin diseases or adhesive allergies that prevent the attachment of a continuous glucose monitoring (CGM) sensor 9. Pregnant or breastfeeding individuals 10. Expected major changes in medications that may influence autonomic or cardiovascular responses during the study period 11. Any other condition that the investigator considers inappropriate for study participation due to safety concerns or potential impact on study outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in autonomic nervous system activity measured by heart rate variability (log-RMSSD);Postprandial glucose response measured as incremental area under the curve (iAUC 0–120 min) using continuous glucose monitoring | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in blood pressure including systolic blood pressure (SBP) and diastolic blood pressure (DBP);Changes in autonomic nervous system parameters including heart rate variability indices such as high frequency, low frequency to high frequency ratio, standard deviation of normal-to-normal intervals, and heart rate;Changes in glucose dynamics measured by continuous glucose monitoring including Cmax, Tmax, and mean glucose levels;Change in subjective stress level measured by VAS (VAS-Stress);Change in subjective relaxation level measured by VAS (VAS-Relaxation);Change in health-related quality of life measured by EQ-VAS | — |
Countries
Korea, Republic of
Contacts
Public ContactBo-Young Youn
Daejeon University
Outcome results
None listed