NCT04812288

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 9, 2019

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

21 days

First QC Date

March 17, 2021

Last Update Submit

March 22, 2021

Conditions

Oxygenation

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • time to finish the Timed Up and Go test (Only measure one time at a single time point, does not measure changes)

    Day1

  • Short Physical Performance Battery score (Only measure one time at a single time point, does not measure changes)

    Day1

  • distance finished in the 2-Minute Walking test (Only measure one time at a single time point, does not measure changes)

    Day1

  • the number of heel raise finished within one minute (Only measure one time at a single time point, does not measure changes)

    Day1

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Older adults aged 60 and over were included.

You may qualify if:

  • individuals who are 60 years old or older
  • who are ambulatory with or without a mobility device
  • can follow instructions without assistance

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo

Buffalo, New York, 14214, United States

Location

Study Officials

  • Fei Zhao, MPT

    University at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 23, 2021

Study Start

June 9, 2019

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

March 23, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)