NCT05266170

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

March 23, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2022

Completed
Last Updated

March 1, 2023

Status Verified

January 1, 2022

Enrollment Period

9 months

First QC Date

February 6, 2022

Last Update Submit

February 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Reduction on metabolic energy expenditure (ml·kg-1·min-1)

    3hours

  • Reduction on heart rate (beats per minute, bpm)

    3hours

  • Distinction on muscle activity (%MVC)

    3hours

  • Distinction on metabolic energy expenditure (ml·kg-1·min-1)

    3hours

  • Distinction on heart rate (beats per minute, bpm)

    3hours

  • +1 more secondary outcomes

Study Arms (1)

Normal adults

aerobic and anaerobic exercises

Device: aerobic and anaerobic exercises

Interventions

\[aerobic\] 1. Aerobic treadmill walking program without EX1 2. Aerobic treadmill walking program with EX1 3. High-intensity interval exercise (HIIT) program with EX1 \[anaerobic\] 1\. Fitness exercise program with EX1

Normal adults

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Normal adults aged 19 to 65 years

You may qualify if:

  • Healthy adults aged 19 to 65 years without a history of central nervous system disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Study Officials

  • Yun-Hee Kim, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2022

First Posted

March 4, 2022

Study Start

March 23, 2022

Primary Completion

December 28, 2022

Study Completion

December 28, 2022

Last Updated

March 1, 2023

Record last verified: 2022-01

Locations