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

NCT ID: NCT04914364

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-23
• Study Completion Date: 2022-06-22

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.

Conditions

Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Intervention Type: OTHER

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

Interventions

Balance assessments

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashley Poole

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

Duke University Health System

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00108353

Identifier Type: -

Identifier Source: org_study_id