Covid19NCT04914364
Balance Function in Patients Post Corona Virus Disease 2019 (COVID-19)
An observational study of Covid19, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Balance assessments
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2021to 22 Jun 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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).
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- History of 2 or more falls in the year prior to COVID-19 diagnosis or history of balance dysfunction
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27615
About this study
Official title: Describing Balance Function in Patients Post-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.
Read the 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
- Being tested
- Balance assessments
- Keywords
- COVID, Balance
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance assessmentsOther
There is no formal intervention in this study. The investigators will only be completing balance assessments with no follow-up visit.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Balance assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (2)
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 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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start23 Jul 2021
- Primary completion22 Jun 2022
- Study completion22 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashley Poole, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914364
- Sponsor's protocol ID
- Pro00108353
- Status last verified
- Sep 2024
- First submitted
- 2 Jun 2021
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Describing Balance Function in Patients Post-COVID-19
- ClinicalTrials.gov ID
- NCT04914364
- Acronym / sponsor ID
- Pro00108353
- Conditions
- Covid19
- Keywords
- COVID, Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 4 Jun 2021 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who have tested positive for COVID-19 | – | Other: Balance assessmentsPatients who are designated as "COVID recovered" in the electronic medical record and who fit the inclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (1 listed)
- History of 2 or more falls in the year prior to COVID-19 diagnosis or history of balance dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance assessmentsThere is no formal intervention in this study. The investigators will only be completing balance assessments with no follow-up visit. | Other | Patients who have tested positive for COVID-19 |
Primary outcome
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.
2 secondary outcomes
Sensory Influence on Balance as Measured by Modified Clinical Test of Sensory Interaction in Balance (mCTSIB)
Time frame: Baseline
Balance Confidence as Measured by Activities Specific Balance Confidence (ABC) Scale
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley Poole principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Balance as Measured by Timed Up and Go (TUG) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.