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

Completed

• Conditions: Covid19
• Interventions: Other: Balance assessments

• Registration Number: NCT04914364
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to describe balance deficits in patients post COVID-19. The information the investigators learn may help influence balance training exercises for patients post-COVID-19. Participants will have a primary or secondary diagnosis of COVID-19 during hospitalization and off COVID-19 isolation and be receiving care in an acute inpatient hospital. Following consent, participants will complete balance assessments and questionnaires about balance and dizziness in a single session. Vital signs will be monitored during the session.The greatest risks of this study include shortness of breath, and a risk of falling or musculoskeletal soreness.These risks are no greater than those experienced during a usual physical therapy visit.

Detailed Description

Heart rate (HR), respiratory rate (RR), blood pressure (BP), and oxygen saturation (SpO2) will be measured at rest and after all outcome measures are completed. Rate of Perceived Exertion (RPE) (0-10 per modified Borg scale) will be measured after each outcome measure. In addition, HR will be measured after each outcome measure. SpO2 will be continually monitored via pulse oximetry. Fraction of inspired oxygen (FiO2) will be titrated per MD orders. If SpO2 drops below MD-specified parameters, patients will first be given a 3-minute seated rest break. If SpO2 recovers above MD-specified parameters after rest break, activity will resume. If SpO2 remains below MD-specified parameters after rest break or continues to drop with activity, FiO2 will be titrated to maintain SpO2 within MD-specified parameters.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-02
• Study First Posted: 2021-06-04
• Study Start: 2021-07-23
• Primary Completion: 2022-06-22
• Study Completion: 2022-06-22
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Age > 18 years
• Primary or secondary diagnosis of COVID- 19 during hospitalization and off COVID-19 isolation
• Receiving care in acute inpatient
• Ability to ambulate 20' with or without an assistive device without dropping >10% of resting oxygen saturation (determined from existing physical therapy evaluation)
• Ability to stand with no more than contact guard assistance (determined from existing physical therapy evaluation)
• Not requiring use of mechanical ventilation
• Minimum resting oxygen saturation of 88% with or without supplemental oxygen
• No neurological or orthopedic dysfunction that would affect balance
• Cognitively intact and able to follow directions and provide consent

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Exclusion Criteria

• History of 2 or more falls in the year prior to COVID-19 diagnosis or history of balance dysfunction

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who have tested positive for COVID-19	Balance assessments	Patients who are designated as "COVID recovered" in the electronic medical record and who fit the inclusion criteria.

Primary Outcome Measures

Name	Time	Method
Motor Balance as Measured by Timed Up and Go (TUG)	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Sensory Influence on Balance as Measured by Modified Clinical Test of Sensory Interaction in Balance (mCTSIB)	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.
Balance Confidence as Measured by Activities Specific Balance Confidence (ABC) Scale	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.

Trial Locations

Locations (1)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States