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

NCT04914364 | Completed Results

• 1 other identifier: Pro00108353
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

COVID; Balance

Outcome Measures

Primary Outcomes (1)

• Motor Balance as Measured by Timed Up and Go (TUG)

  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.

  Baseline

Secondary Outcomes (2)

• Sensory Influence on Balance as Measured by Modified Clinical Test of Sensory Interaction in Balance (mCTSIB)

  Baseline

• Balance Confidence as Measured by Activities Specific Balance Confidence (ABC) Scale

  Baseline

Study Arms (1)

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

Interventions

Balance assessments OTHER

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

Patients who have tested positive for COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27615, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Ashley Poole
• Organization: Duke University

ashley.poole@duke.edu

919-538-6272

Study Officials

• Ashley Poole

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 4, 2021
• Study Start: July 23, 2021
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)