Long-term Exercise Effect of EX1 Exercise Program
- Conditions
- Aging
- Interventions
- Device: Without Wearable Hip Assist Robot(EX1)Device: Wearable Hip Assist Robot(EX1)Behavioral: Exercise Program 2Behavioral: Exercise Program 1
- Registration Number
- NCT05862077
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- Healthy adults aged 19 to less than 65 years without a history of central nervous system disease
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise program 2 with EX1 Exercise Program 2 Exercise program 2 consists of 30 minutes of overground walking. Overground walking exercise without EX1 Without Wearable Hip Assist Robot(EX1) Exercise consists of 30 minutes of overground walking. Exercise program 2 with EX1 Wearable Hip Assist Robot(EX1) Exercise program 2 consists of 30 minutes of overground walking. Exercise program 1 with EX1 Exercise Program 1 Exercise program 1 consists of 30 minutes of overground walking. Exercise program 1 with EX1 Wearable Hip Assist Robot(EX1) Exercise program 1 consists of 30 minutes of overground walking.
- Primary Outcome Measures
Name Time Method Change on gait function (muscle activation) Session 0 (initial visit); after session 18 (at approximately 6 weeks) All subjects perform overground walking to assess the change of muscle activation after the interventions using a surface EMG (6 channels).
- Secondary Outcome Measures
Name Time Method User Satisfaction Questionnaire After session 18 (at approximately 6 weeks) We evaluate the satisfaction questionnaire for EX1 use and exercise program.
Change in heart rate Every session (total 18 sessions/ 30 minutes) All subjects are measured for heart rate during the intervention.
Reduction in body fat percentage Session 0 (initial visit); after session 18 (at approximately 6 weeks) All subjects are measured for body fat before and after the intervention.
Change on gait function (kinematic) Session 0 (initial visit); after session 18 (at approximately 6 weeks) All subjects perform overground walking to assess the change of kinematic using a motion analysis.
Reduction in stress level Session 0 (initial visit); after session 18 (at approximately 6 weeks) 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.
Trial Locations
- Locations (1)
Sungkyunkwan University
🇰🇷Suwon, Korea, Republic of