- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04812288
Oxygenation and Muscle Function's Relationship During SLIE in Older Adults
March 22, 2021 updated by: Fei Zhao, State University of New York at Buffalo
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
62
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Buffalo, New York, United States, 14214
- University at Buffalo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Older adults aged 60 and over were included.
Description
Inclusion Criteria:
- individuals who are 60 years old or older
- who are ambulatory with or without a mobility device
- can follow instructions without assistance
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day1
|
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
|
Day1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
Day1
|
Short Physical Performance Battery score (Only measure one time at a single time point, does not measure changes)
Time Frame: Day1
|
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.
|
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
|
This test measures the maximum distance in meters covered in 2 minutes.
Longer distance means better endurance.
|
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
|
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.
|
Day1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Fei Zhao, MPT, University at Buffalo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 9, 2019
Primary Completion (Actual)
June 30, 2019
Study Completion (Actual)
June 30, 2019
Study Registration Dates
First Submitted
March 17, 2021
First Submitted That Met QC Criteria
March 22, 2021
First Posted (Actual)
March 23, 2021
Study Record Updates
Last Update Posted (Actual)
March 23, 2021
Last Update Submitted That Met QC Criteria
March 22, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00003426
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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