An observational study in Covid19, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Duke University · Observational
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 28 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
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).
Exclusion Criteria:
Patients who are designated as "COVID recovered" in the electronic medical record and who fit the inclusion criteria.
Other: Balance assessments
There is no formal intervention in this study. The investigators will only be completing balance assessments with no follow-up visit.
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.
Time frame: Baseline
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.
Time frame: 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.
Time frame: Baseline
Recruited from a large academic medical center.
| Milestone | Patients Who Have Tested Positive for COVID-19 |
|---|---|
| Started | 28 |
| Completed | 25 |
| Not completed | 3 |
| Withdrew: No longer eligible for study | 1 |
| Withdrew: Lost to follow-up | 2 |
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.
| seconds | Patients Who Have Tested Positive for COVID-19 |
|---|---|
| Motor Balance as Measured by Timed Up and Go (TUG) | 20.57 ± 10.34 |
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.
| seconds | Patients Who Have Tested Positive for COVID-19 |
|---|---|
| mCTSIB eyes open firm surface | 30.0 ± 0.00 |
| mCTSIB eyes closed firm surface | 28.28 ± 6.24 |
| mCTSIB eyes open foam surface | 27.50 ± 8.08 |
| mCTSIB eyes closed foam surface | 19.41 ± 1.89 |
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.
| score on a scale | Patients Who Have Tested Positive for COVID-19 |
|---|---|
| Balance Confidence as Measured by Activities Specific Balance Confidence (ABC) Scale | 66.88 ± 17.61 |
Collected over During a single study visit, up to 3 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients Who Have Tested Positive for COVID-19 | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
Participants who completed the study.
| Age, Continuous(years) | Patients Who Have Tested Positive for COVID-19 |
|---|---|
| Mean | 55.6 ± 11.3 |
| Sex: Female, Male(Participants) | Patients Who Have Tested Positive for COVID-19 |
|---|---|
| Female | 8 |
| Male | 17 |
| Ethnicity (NIH/OMB)(Participants) | Patients Who Have Tested Positive for COVID-19 |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 21 |
| Unknown or Not Reported | 4 |
| Race (NIH/OMB)(Participants) | Patients Who Have Tested Positive for COVID-19 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 10 |
| White | 14 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | Patients Who Have Tested Positive for COVID-19 |
|---|---|
| United States | 25 |
| Resting FiO2(percentage of inspired oxygen) | Patients Who Have Tested Positive for COVID-19 |
|---|---|
| Mean | 1.04 ± 2.07 |
| Resting SpO2(percentage of oxygen-saturated blood) | Patients Who Have Tested Positive for COVID-19 |
|---|---|
| Mean | 96.92 ± 2.14 |
| Time since COVID diagnosis(days) | Patients Who Have Tested Positive for COVID-19 |
|---|---|
| Mean | 34.44 ± 15.35 |
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