OxygenationNCT04812288
Oxygenation and Muscle Function's Relationship During SLIE in Older Adults
An observational study of Oxygenation, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
This study is to determine the correlations between oxygenation of calf muscles and physical performance including balance, gait speed, and endurance in older adults by utilizing the NIRS device. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oxygenation
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2019to 30 Jun 2019
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Older adults aged 60 and over were included.
Who may be able to join
- individuals who are 60 years old or older
- who are ambulatory with or without a mobility device
- can follow instructions without assistance
Who cannot join
- having an amputated limb
- current or uncontrolled vestibular disorders
- sensation impairment at the lower extremity
- macular degeneration disease such as glaucoma
- Parkinson's disease
- blood circulation disorders such as chronic venous insufficiency
- individuals without English proficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oxygenation and Muscle Function's Relationship During Short Light-Intensity Exercise in Older Adults
This study is to determine the correlations between oxygenation of calf muscles and physical performance including balance, gait speed, and endurance in older adults by utilizing the NIRS device.
Read the detailed description
The aim of this study is to determine the relationship between oxygenation of calf muscles and physical performance including balance, gait speed, and endurance in older adults by utilizing the NIRS device. The investigators want to determine the relationship between different types of tests and oxygenation for older adults with 4 levels of physical activity. This study will help towards identifying possible short and effective exercises for older adults with different activity levels.
- Conditions
- Oxygenation
What is being measured
The primary outcome is the main question the study is designed to answer.
time to reach the minimum muscular oxygenation level (Only measure one time at a single time point, does not measure changes)
time to reach the minimum muscular oxygenation level during bilateral heel raise test in seconds
Measured: Day1
recovery of muscular oxygenation (Only measure one time at a single time point, does not measure changes)
the muscular oxygenation difference in percentage between the first second and the last second after finishing the bilateral heel raise test for 1 minute
Measured: Day1
Secondary outcomes (4)
time to finish the Timed Up and Go test (Only measure one time at a single time point, does not measure changes)
This test measures time in seconds to finish the Timed Up and Go test from standing from a chair, walking for 3-meter distance, turning around, going back and sitting down. Less seconds means higher mobility. Higher than 12 seconds indicates risk of falls.
Measured: Day1
Short Physical Performance Battery score (Only measure one time at a single time point, does not measure changes)
Three parts including balance, gait speed, and chair stand test are measured. Full points of each part is 4. The score range is from 0 to 12 points. Higher score means higher physical function.
Measured: Day1
distance finished in the 2-Minute Walking test (Only measure one time at a single time point, does not measure changes)
This test measures the maximum distance in meters covered in 2 minutes. Longer distance means better endurance.
Measured: Day1
the number of heel raise finished within one minute (Only measure one time at a single time point, does not measure changes)
This test measures the number of heel raise that participants can complete within one minute. More heel raise times means more endurance at the calf muscle.
Measured: Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start9 Jun 2019
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OxygenationStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Zhao, State University of New York at Buffalo
- Investigators
- Fei Zhao, MPT, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812288
- Sponsor's protocol ID
- STUDY00003426
- Status last verified
- Mar 2021
- First submitted
- 17 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygenation and Muscle Function's Relationship During Short Light-Intensity Exercise in Older Adults
- ClinicalTrials.gov ID
- NCT04812288
- Acronym / sponsor ID
- STUDY00003426
- Conditions
- Oxygenation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 9 Jun 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 23 Mar 2021 (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.
This study is to determine the correlations between oxygenation of calf muscles and physical performance including balance, gait speed, and endurance in older adults by utilizing the NIRS device.
Detailed description
The aim of this study is to determine the relationship between oxygenation of calf muscles and physical performance including balance, gait speed, and endurance in older adults by utilizing the NIRS device. The investigators want to determine the relationship between different types of tests and oxygenation for older adults with 4 levels of physical activity. This study will help towards identifying possible short and effective exercises for older adults with different activity levels.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Older adults aged 60 and over were included.
Key inclusion criteria (3 listed)
- individuals who are 60 years old or older
- who are ambulatory with or without a mobility device
- can follow instructions without assistance
Key exclusion criteria (7 listed)
- having an amputated limb
- current or uncontrolled vestibular disorders
- sensation impairment at the lower extremity
- macular degeneration disease such as glaucoma
- Parkinson's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
time to reach the minimum muscular oxygenation level (Only measure one time at a single time point, does not measure changes)
Time frame: Day1
time to reach the minimum muscular oxygenation level during bilateral heel raise test in seconds
recovery of muscular oxygenation (Only measure one time at a single time point, does not measure changes)
Time frame: Day1
the muscular oxygenation difference in percentage between the first second and the last second after finishing the bilateral heel raise test for 1 minute
4 secondary outcomes
time to finish the Timed Up and Go test (Only measure one time at a single time point, does not measure changes)
Time frame: Day1
Short Physical Performance Battery score (Only measure one time at a single time point, does not measure changes)
Time frame: Day1
distance finished in the 2-Minute Walking test (Only measure one time at a single time point, does not measure changes)
Time frame: Day1
the number of heel raise finished within one minute (Only measure one time at a single time point, does not measure changes)
Time frame: Day1
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 23 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Fei Zhao, MPT principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxygenation, run by State University of New York at Buffalo at 1 site in United States.
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 7 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 23 Mar 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 United States. 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?
time to reach the minimum muscular oxygenation level (Only measure one time at a single time point, does not measure changes) (time frame: Day1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2021.