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

Describing Balance Function in Patients Post-COVID-19

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: Balance assessments

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.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27615
      • Duke University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects will be adults who have primary or secondary diagnosis of COVID-19 during hospitalization and off COVID-19 isolation and be receiving care in an acute inpatient hospital (Duke University Health System).

Description

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Balance assessments; There is no formal intervention in this study. The investigators will only be completing balance assessments with no follow-up visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor balance as measured by Timed Up and Go (TUG)	The TUG measures mobility, motor balance, walking ability, and falls risk based on one composite score of how long it takes the patient to complete the task.	Baseline - single session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory influence on balance as measured by Modified Clinical Test of Sensory Interaction in Balance (mCTSIB)	The mCTSIB assesses how well a patient is using sensory inputs when one or more sensory systems are compromised.	Baseline - single session
Balance confidence as measured by Activities Specific Balance Confidence (ABC) Scale	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.	Baseline - single session

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dizziness as measured by a dizziness questionnaire	Visual analog scale that ranges from 0-10 where 0 indicates no dizziness and 10 indicates maximal dizziness.	Baseline - single session

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Ashley Poole, Duke Health

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2021
• Primary Completion (Actual): June 22, 2022
• Study Completion (Actual): June 22, 2022

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Balance; COVID
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Pro00108353

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