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Aerobic ExercisesNCT05266170

The Effect of EX1 Training in Normal Adults

An observational study of Aerobic Exercises and Anaerobic Exercises, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Aerobic Exercises, Anaerobic Exercises
What is being tested?
aerobic and anaerobic exercises
Type of treatment
Medical device
How many people
40 participants
Where
1 siteSouth Korea
Study dates
23 Mar 2022to 28 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Normal adults aged 19 to 65 years

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
aerobic and anaerobic exercises

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aerobic and anaerobic exercisesDevice

    [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
Study groups in NCT05266170
Study groupRoleWhat they receive
Normal adultsaerobic and anaerobic exercises
Receives: Device: aerobic and anaerobic exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3hours/2hours

Secondary outcomes (6)

  1. 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.

    Measured: 3hours

  2. 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.

    Measured: 3hours

  3. Distinction on muscle activity (%MVC)

    [aerobic] Exercising with EX1 results in higher muscle activity than exercising without wearing EX1.

    Measured: 3hours

  4. 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.

    Measured: 3hours

  5. 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.

    Measured: 3hours

  6. Distinction on muscle activity (%MVC)

    [anaerobic] Fitness movements using EX1 generate more muscle activity than exercise without EX1.

    Measured: 2hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2022
  2. Study start23 Mar 2022
  3. Primary completion28 Dec 2022
  4. Study completion28 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05266170
Sponsor's protocol ID
2021-12-153
Status last verified
Jan 2022
First submitted
6 Feb 2022
Last updated
1 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Aerobic Exercises and Anaerobic Exercises, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction on muscle activity (%MVC) (time frame: 3hours/2hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05266170.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.

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