Skip to main content
OpenTrials
Completed

NCT Number: NCT04914364

Balance Function in Patients Post Corona Virus Disease 2019 (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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Health System

Durham, North Carolina, 27615, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Balance assessments

Other

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

Primary outcomes

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

    Time frame: Baseline

    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.

Secondary outcomes

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

    Time frame: Baseline

    The mCTSIB assesses how well a patient is using sensory inputs when one or more sensory systems are compromised based on how long it takes the patient to complete the task under four different conditions. 1) Eyes Open, Firm Surface; 2) Eyes Closed, Firm Surface; 3) Eyes Open, Foam Surface; 4) Eyes Closed, Foam Surface. The trial is over when (a) the participant opens his/her eyes in an eyes closed condition, (b) raises arms from sides, (c) loses balance and requires manual assistance to prevent a fall.

  2. Balance Confidence as Measured by Activities Specific Balance Confidence (ABC) Scale

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Describing Balance Function in Patients Post-COVID-19

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 4, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.