The Effect of EX1 Training in Normal Adults

The Effect of EX1 Training on Muscle Activity, Heart Rate, and Respiratory Metabolic Energy Consumption Rate in Normal Adults

In this study, when performing aerobic and anaerobic exercise with EX1 applied to normal adults between the ages of 19 and 65. The purpose of this study was to determine the effect on the muscle activity of the trunk and lower extremities compared with and without EX1.

Study Overview

• Status: Completed
• Conditions: Aerobic Exercises; Anaerobic Exercises
• Intervention / Treatment: Device: aerobic and anaerobic exercises

Detailed Description

In this study, aerobic exercise and anaerobic exercise for normal adults were divided into two visits for a total. For aerobic exercise, the investigators compared the aerobic treadmill walking program without EX1 [30 minutes of moderate (64-76% HRmax, 12-14 of RPE) aerobic treadmill walking, 40 minutes including warm-up and cool-down times], the aerobic treadmill walking program with EX1 [30 minutes of moderate (64-76% HRmax, 12-14 of RPE) aerobic treadmill walking, 40 minutes including warm-up and cool-down times] , and the high-intensity interval exercise (HIIT) program with EX1 [High-intensity-low-intensity interval walking exercise was performed at treadmill speed (High: 90-95% HRmax, 15-17 of RPE/Low: 60-70% HRmax, 9-11 of RPE) and EX1 resistance strength (High: resistance intensity 7- 9/Low: Resistance strength 0-2)] to check the effect on muscle activity, heart rate, and respiratory metabolic energy consumption rate.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Normal adults aged 19 to 65 years

Description

Inclusion Criteria:

• Healthy adults aged 19 to 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 understanding the exercise program due to severe cognitive decline (Korean-Mini-Mental State Examination, K-MMSE≤10)
• 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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal adults; aerobic and anaerobic exercises	Device: aerobic and anaerobic exercises; [aerobic]; Aerobic treadmill walking program without EX1; Aerobic treadmill walking program with EX1; High-intensity interval exercise (HIIT) program with EX1 [anaerobic] 1. Fitness exercise program with EX1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction on muscle activity (%MVC)	[aerobic] All subjects underwent measurements of the trunk and lower extremity muscle activity (%MVC) during aerobic treadmill walking and measured by three conditions (①Aerobic treadmill walking program without EX1, ②Aerobic treadmill walking program with EX1, and ③High-intensity interval exercise (HIIT) program with EX1. [anaerobic] All subjects underwent measurements of the trunk and lower extremity muscle activity (%MVC) during each condition	3hours/2hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction on metabolic energy expenditure (ml·kg-1·min-1)	[aerobic] All subjects underwent measurements of respiratory metabolism energy (ml·kg-1·min-1) during aerobic treadmill walking and measured by three conditions (①Aerobic treadmill walking program without EX1, ②Aerobic treadmill walking program with EX1, and ③High-intensity interval exercise (HIIT) program with EX1.	3hours
Reduction on heart rate (beats per minute, bpm)	[aerobic] All subjects underwent measurements of heart rate (bpm) during aerobic treadmill walking and measured by three conditions (①Aerobic treadmill walking program without EX1, ②Aerobic treadmill walking program with EX1, and ③High-intensity interval exercise (HIIT) program with EX1.	3hours
Distinction on muscle activity (%MVC)	[aerobic] Exercising with EX1 results in higher muscle activity than exercising without wearing EX1.	3hours
Distinction on metabolic energy expenditure (ml·kg-1·min-1)	[aerobic] Exercising with EX1 consumes more energy for the same amount of time than exercising without wearing EX1.	3hours
Distinction on heart rate (beats per minute, bpm)	[aerobic] Exercising with EX1 shows a higher heart rate for the same time than exercising without EX1.	3hours
Distinction on muscle activity (%MVC)	[anaerobic] Fitness movements using EX1 generate more muscle activity than exercise without EX1.	2hours

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Actual): December 28, 2022
• Study Completion (Actual): December 28, 2022

Study Registration Dates

• First Submitted: February 6, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2021-12-153

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No