Trial Outcomes & Findings for Balance Function in Patients Post Corona Virus Disease 2019 (COVID-19) (NCT NCT04914364)

Last Updated: 2024-09-19

Results Overview

The TUG measures mobility, motor balance, walking ability, and falls risk based on how long it takes the patient to stand up, walk 10 feet, turn around, walk back, and sit down. \< 10 seconds = normal, \< 20 seconds = good mobility; can walk outside alone; does not require a walking aid, \< 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid.

Recruitment status

COMPLETED

Target enrollment

28 participants

Primary outcome timeframe

Baseline

Results posted on

2024-09-19

Participant Flow

Recruited from a large academic medical center.

Participant milestones

Participant milestones
Measure	Patients Who Have Tested Positive for COVID-19 Patients who are designated as "COVID recovered" in the electronic medical record and who fit the inclusion criteria. Balance assessments: There is no formal intervention in this study. The investigators will only be completing balance assessments with no follow-up visit.
Overall Study STARTED	28
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients Who Have Tested Positive for COVID-19 Patients who are designated as "COVID recovered" in the electronic medical record and who fit the inclusion criteria. Balance assessments: There is no formal intervention in this study. The investigators will only be completing balance assessments with no follow-up visit.
Overall Study No longer eligible for study	1
Overall Study Lost to Follow-up	2

Baseline Characteristics

Balance Function in Patients Post Corona Virus Disease 2019 (COVID-19)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Who Have Tested Positive for COVID-19 n=25 Participants Patients who are designated as "COVID recovered" in the electronic medical record and who fit the inclusion criteria. Balance assessments: There is no formal intervention in this study. The investigators will only be completing balance assessments with no follow-up visit.
Age, Continuous	55.6 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	25 Participants n=5 Participants
Resting FiO2	1.04 percentage of inspired oxygen STANDARD_DEVIATION 2.07 • n=5 Participants
Resting SpO2	96.92 percentage of oxygen-saturated blood STANDARD_DEVIATION 2.14 • n=5 Participants
Time since COVID diagnosis	34.44 days STANDARD_DEVIATION 15.35 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Patients Who Have Tested Positive for COVID-19 n=25 Participants Patients who are designated as "COVID recovered" in the electronic medical record and who fit the inclusion criteria. Balance assessments: There is no formal intervention in this study. The investigators will only be completing balance assessments with no follow-up visit.
Motor Balance as Measured by Timed Up and Go (TUG)	20.57 seconds Standard Deviation 10.34

SECONDARY outcome

Timeframe: Baseline

The mCTSIB assesses how well a patient is using sensory inputs when one or more sensory systems are compromised based on how long it takes the patient to complete the task under four different conditions. 1) Eyes Open, Firm Surface; 2) Eyes Closed, Firm Surface; 3) Eyes Open, Foam Surface; 4) Eyes Closed, Foam Surface. The trial is over when (a) the participant opens his/her eyes in an eyes closed condition, (b) raises arms from sides, (c) loses balance and requires manual assistance to prevent a fall.

Outcome measures

Outcome measures
Measure	Patients Who Have Tested Positive for COVID-19 n=25 Participants Patients who are designated as "COVID recovered" in the electronic medical record and who fit the inclusion criteria. Balance assessments: There is no formal intervention in this study. The investigators will only be completing balance assessments with no follow-up visit.
Sensory Influence on Balance as Measured by Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) mCTSIB eyes open firm surface	30.0 seconds Standard Deviation 0.00
Sensory Influence on Balance as Measured by Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) mCTSIB eyes closed firm surface	28.28 seconds Standard Deviation 6.24
Sensory Influence on Balance as Measured by Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) mCTSIB eyes open foam surface	27.50 seconds Standard Deviation 8.08
Sensory Influence on Balance as Measured by Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) mCTSIB eyes closed foam surface	19.41 seconds Standard Deviation 1.89

SECONDARY outcome

Timeframe: Baseline

Self-report questionnaire where patients rate their balance confidence for performing activities. Scores range 0-100 where 0 indicates no balance confidence and 100 indicates complete balance confidence.

Outcome measures

Outcome measures
Measure	Patients Who Have Tested Positive for COVID-19 n=25 Participants Patients who are designated as "COVID recovered" in the electronic medical record and who fit the inclusion criteria. Balance assessments: There is no formal intervention in this study. The investigators will only be completing balance assessments with no follow-up visit.
Balance Confidence as Measured by Activities Specific Balance Confidence (ABC) Scale	66.88 score on a scale Standard Deviation 17.61

Adverse Events

Patients Who Have Tested Positive for COVID-19

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ashley Poole

Duke University

Phone: 919-538-6272

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place