AgingNCT05862077
Long-term Exercise Effect of EX1 Exercise Program
A study testing Wearable Hip Assist Robot(EX1), Exercise Program 1 and Exercise Program 2 in people with Aging, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Wearable Hip Assist Robot(EX1), Exercise Program 1 and Exercise Program 2
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Mar 2023to 31 Oct 2023
- Phase
- Interventional
- 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
Who may be able to join
- Healthy adults aged 19 to less than 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 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.
About this study
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.
- Conditions
- Aging
- Being tested
- Wearable Hip Assist Robot(EX1), Exercise Program 1, Exercise Program 2, Without Wearable Hip Assist Robot(EX1)
- Keywords
- Exercise program, Wearable hip assist robot, Gait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Hip Assist Robot(EX1)Device
EX1 is a hip-type assist device developed by Samsung Electronics.
Exercise Program 1Behavioural
Exercise program 1 for fast walking by applying resistance and assist mode of EX1
Exercise Program 2Behavioural
Exercise program 2 for normal walking by applying resistance and assist mode of EX1
Without Wearable Hip Assist Robot(EX1)Device
Overground walking without EX1
| Study group | Role | What they receive |
|---|---|---|
| Overground walking exercise without EX1 | Sham comparator | Exercise consists of 30 minutes of overground walking. Receives: Device: Without Wearable Hip Assist Robot(EX1) |
| Exercise program 1 with EX1 | Experimental | Exercise program 1 consists of 30 minutes of overground walking. Receives: Device: Wearable Hip Assist Robot(EX1); Behavioral: Exercise Program 1 |
| Exercise program 2 with EX1 | Experimental | Exercise program 2 consists of 30 minutes of overground walking. Receives: Device: Wearable Hip Assist Robot(EX1); Behavioral: Exercise Program 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Session 0 (initial visit); after session 18 (at approximately 6 weeks)
Secondary outcomes (5)
Change in heart rate
All subjects are measured for heart rate during the intervention.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Session 0 (initial visit); after session 18 (at approximately 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start28 Mar 2023
- Primary completion30 Sep 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Electronics
- Responsible party
- Principal investigator, Yun-Hee Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862077
- Sponsor's protocol ID
- 2023-03-005
- Status last verified
- Feb 2024
- First submitted
- 22 Mar 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee SH, Kim E, Kim J, Kim D, Lee D, Lee HJ, Kim YH. Effect of Programed Walking Exercise Using Bot Fit in Younger Adults. Sports Med Open. 2024 Oct 14;10(1):112. doi: 10.1186/s40798-024-00773-x.
PubMed 39400778
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Exercise Effect of EX1 Exercise Program
- ClinicalTrials.gov ID
- NCT05862077
- Acronym / sponsor ID
- 2023-03-005
- Conditions
- Aging
- Keywords
- Exercise program, Wearable hip assist robot, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Samsung Electronics
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Overground walking exercise without EX1 | Sham comparator | Device: Without Wearable Hip Assist Robot(EX1)Exercise consists of 30 minutes of overground walking. |
| Exercise program 1 with EX1 | Experimental | Device: Wearable Hip Assist Robot(EX1), Behavioral: Exercise Program 1Exercise program 1 consists of 30 minutes of overground walking. |
| Exercise program 2 with EX1 | Experimental | Device: Wearable Hip Assist Robot(EX1), Behavioral: Exercise Program 2Exercise program 2 consists of 30 minutes of overground walking. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults aged 19 to less than 65 years without a history of central nervous system disease
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Hip Assist Robot(EX1)EX1 is a hip-type assist device developed by Samsung Electronics. | Device | Exercise program 1 with EX1, Exercise program 2 with EX1 |
| Exercise Program 1Exercise program 1 for fast walking by applying resistance and assist mode of EX1 | Behavioural | Exercise program 1 with EX1 |
| Exercise Program 2Exercise program 2 for normal walking by applying resistance and assist mode of EX1 | Behavioural | Exercise program 2 with EX1 |
| Without Wearable Hip Assist Robot(EX1)Overground walking without EX1 | Device | Overground walking exercise without EX1 |
Primary outcome
Change on gait function (muscle activation)
Time frame: Session 0 (initial visit); after session 18 (at approximately 6 weeks)
All subjects perform overground walking to assess the change of muscle activation after the interventions using a surface EMG (6 channels).
5 secondary outcomes
Change in heart rate
Time frame: Every session (total 18 sessions/ 30 minutes)
Reduction in stress level
Time frame: Session 0 (initial visit); after session 18 (at approximately 6 weeks)
Reduction in body fat percentage
Time frame: Session 0 (initial visit); after session 18 (at approximately 6 weeks)
User Satisfaction Questionnaire
Time frame: After session 18 (at approximately 6 weeks)
Change on gait function (kinematic)
Time frame: Session 0 (initial visit); after session 18 (at approximately 6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Derived from this study: PubMed 39400778Lee SH, Kim E, Kim J, Kim D, Lee D, Lee HJ, Kim YH. Effect of Programed Walking Exercise Using Bot Fit in Younger Adults. Sports Med Open. 2024 Oct 14;10(1):112. doi: 10.1186/s40798-024-00773-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Hip Assist Robot(EX1), Exercise Program 1 and Exercise Program 2 in people with Aging, 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 5 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 29 Feb 2024. 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. Some participants in this study may receive a placebo. 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?
Change on gait function (muscle activation) (time frame: Session 0 (initial visit); after session 18 (at approximately 6 weeks)). 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 NCT05862077, which also lists 1 linked publication.
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 29 Feb 2024.