Long-term Exercise Effect of EX1 Exercise Program

Aging Clinical Trial

Official title:

Long-term Exercise Effect of EX1 Exercise Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05862077
• Other study ID #: 2023-03-005
• Status: Completed
• Phase: N/A
• Start date: March 28, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: February 2024
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Aging

Intervention

Device:
• Wearable Hip Assist Robot(EX1)
EX1 is a hip-type assist device developed by Samsung Electronics.

Behavioral:
• Exercise Program 1
Exercise program 1 for fast walking by applying resistance and assist mode of EX1
• Exercise Program 2
Exercise program 2 for normal walking by applying resistance and assist mode of EX1

Device:
• Without Wearable Hip Assist Robot(EX1)
Overground walking without EX1

Locations

Country	Name	City	State
Korea, Republic of	Sungkyunkwan University	Suwon

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Samsung Electronics

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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)