Aging Clinical Trial
Official title:
Long-term Exercise Effect of EX1 Exercise Program
Verified date | February 2024 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study was to investigate the effect of a long-term exercise program using a wearable exoskeleton robot (EX1) on muscular strength in healthy adults aged 19 to under 65 years, compared to an exercise program without EX1.
Status | Completed |
Enrollment | 45 |
Est. completion date | October 31, 2023 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 65 Years |
Eligibility | Inclusion Criteria: - Healthy adults aged 19 to less than 65 years without a history of central nervous system disease Exclusion Criteria: - Those who have difficulty walking independently due to problems such as visual field defects or fractures - Those who have difficulty participating in exercise programs due to adult diseases such as uncontrolled hypertension and diabetes - Those who are at risk of falling while walking due to severe dizziness - Those who are less than 140 cm or more than 185 cm in height that is not suitable size for the wearing of the walking assistance robot - Those who are overweight based on body mass index (BMI) 35 or higher |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Sungkyunkwan University | Suwon |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center | Samsung Electronics |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change on gait function (muscle activation) | All subjects perform overground walking to assess the change of muscle activation after the interventions using a surface EMG (6 channels). | Session 0 (initial visit); after session 18 (at approximately 6 weeks) | |
Secondary | Change in heart rate | All subjects are measured for heart rate during the intervention. | Every session (total 18 sessions/ 30 minutes) | |
Secondary | Reduction in stress level | We evaluate the subject's usual stress level through a questionnaire. The Perceived Stress Scale (PSS-10) is a 10-item questionnaire originally developed by Cohen et al. (1983) widely used to assess stress levels in young people and adults.
The questions ask about feelings and thoughts during the last month. In each case, respondents are asked how often they felt a certain way on a five-point scale from 'never' to 'very often'. Answers are then scored as follow: Never = 0; Almost never = 1; Sometimes = 2; Fairly often = 3; Very often = 4. The PSS score is then obtained by summing across all items. Higher scores indicate higher levels of perceived stress. |
Session 0 (initial visit); after session 18 (at approximately 6 weeks) | |
Secondary | Reduction in body fat percentage | All subjects are measured for body fat before and after the intervention. | Session 0 (initial visit); after session 18 (at approximately 6 weeks) | |
Secondary | User Satisfaction Questionnaire | We evaluate the satisfaction questionnaire for EX1 use and exercise program. | After session 18 (at approximately 6 weeks) | |
Secondary | Change on gait function (kinematic) | All subjects perform overground walking to assess the change of kinematic using a motion analysis. | Session 0 (initial visit); after session 18 (at approximately 6 weeks) |
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