GaitNCT04614857
Correlation Between Cardiopulmonary Metabolic Cost and Lower Limb Muscle Activity
A study testing Inclined treadmill gait in people with Gait, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study was to determine the effect of lower extremity muscle activity on the increase of cardiopulmonary metabolic cost during inclined treadmill gait in the elderly. Read more about this study
- Who is it for?
- Ages 65 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait
- What is being tested?
- Inclined treadmill gait
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Nov 2020to 26 Feb 2021
- 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 65 to 84 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Between 65 and 84 years elderly without neurological effects
- Ability to independent gait at least 16% inclined treadmill
- High levels of physical performance (SPPB > 7)
Who cannot join
- Severe visual impairment or dizziness that increases the risk of falls
- Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery, history of congestive heart failure, documentedserious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy,severe aortic stenosis, angina or dyspnea at rest or during activities ofdaily living)
- Difficult to understand experimental tasks because of extremely severe cognitive impairment
- Recent acute injuries such as fractures within 6 months, or experience in orthopedic surgery such as artificial joint replacement
- Acute injuries such as fractures within 6 months or orthopedic surgery such as artificial joint replacement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Cardiopulmonary Metabolic Cost and Lower Limb Muscle Activity During Inclined Treadmill Gait in the Elderly
The purpose of this study was to determine the effect of lower extremity muscle activity on the increase of cardiopulmonary metabolic cost during inclined treadmill gait in the elderly.
Read the detailed description
The purpose of this study was to determine the effect of lower extremity muscle activity on the increase of cardiopulmonary metabolic cost during inclined treadmill gait in the elderly.
Metabolic energy expenditure and muscle activity are measured simultaneously.
- Conditions
- Gait
- Being tested
- Inclined treadmill gait
- Keywords
- Muscle activity, Cardiopulmonary metabolic cost
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inclined treadmill gaitOther
All subjects underwent measurements of muscle activity and respiratory metabolism energy during treadmill walking at a comfortable speed for 5 minutes and measured by three conditions (#0% inclined treadmill gait, #10% inclined treadmill gait, and #16% inclined treadmill gait)
| Study group | Role | What they receive |
|---|---|---|
| Inclined treadmill gait | Experimental | All subjects underwent measurements of muscle activity and respiratory metabolism energy during treadmill walking at a comfortable speed for 5 minutes and measured by three conditions (#0% inclined treadmill gait, #10% inclined treadmill gait, and #16% inclined treadmill gait) Receives: Other: Inclined treadmill gait |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on metabolic energy expenditure
All subjects underwent measurements respiratory metabolism energy during treadmill walking at a comfortable speed for 5 minutes and measured by three conditions (#0% inclined treadmill gait, #10% inclined treadmill gait, and #16% inclined treadmill gait)
Measured: 1 hour
Secondary outcomes (1)
Change on muscle activity
All subjects underwent measurements of muscle activity during treadmill walking at a comfortable speed for 5 minutes and measured by three conditions (#0% inclined treadmill gait, #10% inclined treadmill gait, and #16% inclined treadmill gait)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start5 Nov 2020
- Primary completion8 Jan 2021
- Study completion26 Feb 2021
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 GaitStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun-Hee Kim, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614857
- Sponsor's protocol ID
- 2020-08-147
- Status last verified
- Oct 2020
- First submitted
- 28 Oct 2020
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim J, Lee HJ, Lee SH, Lee J, Chang WH, Ryu GH, Kim YH. Correlation between cardiopulmonary metabolic energy cost and lower-limb muscle activity during inclined treadmill gait in older adults. BMC Geriatr. 2021 Aug 23;21(1):469. doi: 10.1186/s12877-021-02401-9.
PubMed 34425788
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Cardiopulmonary Metabolic Cost and Lower Limb Muscle Activity During Inclined Treadmill Gait in the Elderly
- ClinicalTrials.gov ID
- NCT04614857
- Acronym / sponsor ID
- 2020-08-147
- Conditions
- Gait
- Keywords
- Muscle activity, Cardiopulmonary metabolic cost
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 8 Jan 2021 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 4 Nov 2020 (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 determine the effect of lower extremity muscle activity on the increase of cardiopulmonary metabolic cost during inclined treadmill gait in the elderly.
Detailed description
The purpose of this study was to determine the effect of lower extremity muscle activity on the increase of cardiopulmonary metabolic cost during inclined treadmill gait in the elderly.
Metabolic energy expenditure and muscle activity are measured simultaneously.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inclined treadmill gait | Experimental | Other: Inclined treadmill gaitAll subjects underwent measurements of muscle activity and respiratory metabolism energy during treadmill walking at a comfortable speed for 5 minutes and measured by three conditions (#0% inclined treadmill gait, #10% inclined treadmill gait, and #16% inclined treadmill gait) |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Between 65 and 84 years elderly without neurological effects
- Ability to independent gait at least 16% inclined treadmill
- High levels of physical performance (SPPB > 7)
Key exclusion criteria (5 listed)
- Severe visual impairment or dizziness that increases the risk of falls
- Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery, history of congestive heart failure, documentedserious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy,severe aortic stenosis, angina or dyspnea at rest or during activities ofdaily living)
- Difficult to understand experimental tasks because of extremely severe cognitive impairment
- Recent acute injuries such as fractures within 6 months, or experience in orthopedic surgery such as artificial joint replacement
- Acute injuries such as fractures within 6 months or orthopedic surgery such as artificial joint replacement
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 |
|---|---|---|
| Inclined treadmill gaitAll subjects underwent measurements of muscle activity and respiratory metabolism energy during treadmill walking at a comfortable speed for 5 minutes and measured by three conditions (#0% inclined treadmill gait, #10% inclined treadmill gait, and #16% inclined treadmill gait) | Other | Inclined treadmill gait |
Primary outcome
Change on metabolic energy expenditure
Time frame: 1 hour
All subjects underwent measurements respiratory metabolism energy during treadmill walking at a comfortable speed for 5 minutes and measured by three conditions (#0% inclined treadmill gait, #10% inclined treadmill gait, and #16% inclined treadmill gait)
1 secondary outcome
Change on muscle activity
Time frame: 1 hour
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 15 Apr 2021.
- Derived from this study: PubMed 34425788Kim J, Lee HJ, Lee SH, Lee J, Chang WH, Ryu GH, Kim YH. Correlation between cardiopulmonary metabolic energy cost and lower-limb muscle activity during inclined treadmill gait in older adults. BMC Geriatr. 2021 Aug 23;21(1):469. doi: 10.1186/s12877-021-02401-9.
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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.
Yun-Hee Kim, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inclined treadmill gait in people with Gait, 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 3 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 15 Apr 2021. 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?
Change on metabolic energy expenditure (time frame: 1 hour). 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 NCT04614857, 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 15 Apr 2021.