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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04812288
Other study ID # STUDY00003426
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 9, 2019
Est. completion date June 30, 2019

Study information

Verified date March 2021
Source State University of New York at Buffalo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date June 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University at Buffalo Buffalo New York

Sponsors (1)

Lead Sponsor Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Day1
Primary 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 Day1
Secondary 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. Day1
Secondary 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. Day1
Secondary 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. Day1
Secondary 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. Day1
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