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

Covid19 Clinical Trial

Official title:

Describing Balance Function in Patients Post-COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04914364
• Other study ID #: Pro00108353
• Status: Completed
• Start date: July 23, 2021
• Est. completion date: June 22, 2022

Study information

• Verified date: July 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 22, 2022
• Est. primary completion date: June 22, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• Balance assessments
There is no formal intervention in this study. The investigators will only be completing balance assessments with no follow-up visit.

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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