Long-term Exercise Effect of EX1 Exercise Program

Study Overview
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Brief Summary
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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.

Official Title
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Long-term Exercise Effect of EX1 Exercise Program

Conditions
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Aging

Intervention / Treatment
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* Device: Wearable Hip Assist Robot(EX1)
* Behavioral: Exercise Program 1
* Behavioral: Exercise Program 2
* Device: Without Wearable Hip Assist Robot(EX1)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Overground walking exercise without EX1<br>Exercise consists of 30 minutes of overground walking. | Device: Without Wearable Hip Assist Robot(EX1)<br>* Overground walking without EX1<br>|
| Experimental: Exercise program 1 with EX1<br>Exercise program 1 consists of 30 minutes of overground walking. | Device: Wearable Hip Assist Robot(EX1)<br>* EX1 is a hip-type assist device developed by Samsung Electronics.<br>Behavioral: Exercise Program 1<br>* Exercise program 1 for fast walking by applying resistance and assist mode of EX1<br>|
| Experimental: Exercise program 2 with EX1<br>Exercise program 2 consists of 30 minutes of overground walking. | Device: Wearable Hip Assist Robot(EX1)<br>* EX1 is a hip-type assist device developed by Samsung Electronics.<br>Behavioral: Exercise Program 2<br>* Exercise program 2 for normal walking by applying resistance and assist mode of EX1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heart rate | All subjects are measured for heart rate during the intervention. | Every session (total 18 sessions/ 30 minutes) | 
| 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) | 
| 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) | 
| User Satisfaction Questionnaire | We evaluate the satisfaction questionnaire for EX1 use and exercise program. | After session 18 (at approximately 6 weeks) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise program, Wearable hip assist robot, Gait