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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balance assessments | Other | There is no formal intervention in this study. The investigators will only be completing balance assessments with no follow-up visit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Ashley Poole | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Health System | Durham | North Carolina | 27615 | United States |
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Recruited from a large academic medical center.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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: There is no formal intervention in this study. The investigators will only be completing balance assessments with no follow-up visit. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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: There is no formal intervention in this study. The investigators will only be completing balance assessments with no follow-up visit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | seconds | Baseline |
|
During a single study visit, up to 3 hours
All assessments were performed during one study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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: There is no formal intervention in this study. The investigators will only be completing balance assessments with no follow-up visit. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashley Poole | Duke University | 919-538-6272 | ashley.poole@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 30, 2021 | Sep 8, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 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. | Baseline |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Resting FiO2 | The fraction of inspired oxygen (FiO2) is an estimation of the oxygen content a person inhales. | Mean | Standard Deviation | percentage of inspired oxygen |
|
| Resting SpO2 | SpO2 is the percentage of blood that is saturated with oxygen. | Mean | Standard Deviation | percentage of oxygen-saturated blood |
|
| Time since COVID diagnosis | Mean | Standard Deviation | days |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | seconds | Baseline |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
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| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
|
| mCTSIB eyes closed foam surface |
|