Clinical trial NCT04914364: Balance Function in Patients Post Corona Virus Disease 2019 (COVID-19)
Official title: Describing Balance Function in Patients Post-COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: COVID
Balance
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Motor Balance as Measured by Timed Up and Go (TUG)
timeFrame: Baseline
Secondary outcomes:
measure: Sensory Influence on Balance as Measured by Modified Clinical Test of Sensory Interaction in Balance (mCTSIB)
timeFrame: Baseline
measure: Balance Confidence as Measured by Activities Specific Balance Confidence (ABC) Scale
timeFrame: Baseline
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke Health
name: Ashley Poole
role: PRINCIPAL_INVESTIGATOR
References: