Covid19
Conditions
Keywords
COVID, Balance
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.
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.
Interventions
OTHERBalance assessments
There is no formal intervention in this study. The investigators will only be completing balance assessments with no follow-up visit.
Sponsors
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor Balance as Measured by Timed Up and Go (TUG) | 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
| Measure | Time frame | Description |
|---|---|---|
| Sensory Influence on Balance as Measured by Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) | 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. |
| Balance Confidence as Measured by Activities Specific Balance Confidence (ABC) Scale | 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. |
Countries
United States
Participant flow
Recruitment details
Recruited from a large academic medical center.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | No longer eligible for study | 1 |
Baseline characteristics
| Characteristic | Patients Who Have Tested Positive for COVID-19 |
|---|---|
| Age, Continuous | 55.6 years STANDARD_DEVIATION 11.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 25 Participants |
| Resting FiO2 | 1.04 percentage of inspired oxygen STANDARD_DEVIATION 2.07 |
| Resting SpO2 | 96.92 percentage of oxygen-saturated blood STANDARD_DEVIATION 2.14 |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 17 Participants |
| Time since COVID diagnosis | 34.44 days STANDARD_DEVIATION 15.35 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Who Have Tested Positive for COVID-19 | Motor Balance as Measured by Timed Up and Go (TUG) | 20.57 seconds | Standard Deviation 10.34 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Who Have Tested Positive for COVID-19 | Balance Confidence as Measured by Activities Specific Balance Confidence (ABC) Scale | 66.88 score on a scale | Standard Deviation 17.61 |
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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Who Have Tested Positive for COVID-19 | Sensory Influence on Balance as Measured by Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) | mCTSIB eyes open firm surface | 30.0 seconds | Standard Deviation 0 |
| Patients Who Have Tested Positive for COVID-19 | Sensory Influence on Balance as Measured by Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) | mCTSIB eyes closed firm surface | 28.28 seconds | Standard Deviation 6.24 |
| Patients Who Have Tested Positive for COVID-19 | Sensory Influence on Balance as Measured by Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) | mCTSIB eyes open foam surface | 27.50 seconds | Standard Deviation 8.08 |
| Patients Who Have Tested Positive for COVID-19 | Sensory Influence on Balance as Measured by Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) | mCTSIB eyes closed foam surface | 19.41 seconds | Standard Deviation 1.89 |