Brief Summary
The objective of this study is to compare the effects of twice-a-day 15-minute sessions of inpatient physical therapy (PT) to the standard daily 30 minute sessions. The patient outcomes that will be evaluated will be length of stay, change in functional status, and disposition (home/acute rehab vs. subacute/LTAC/death) in patients admitted with COVID-19.
Brief Title
Comparing Inpatient COVID-19 Outcomes in 2 Different PT Dosing Groups
Detailed Description
The 2019 pandemic struck New York City hospitals early and aggressively. In rehabilitating inpatients during the early part of the pandemic, we learned that many of them were too affected by the COVID-19 illness to be able to tolerate the typical 30-minute daily session of physical therapy. At that time, the physical therapy (PT) staff often accommodated patients by dividing the typical 30 minute daily session into two 15 minute sessions in an effort to increase patient tolerance and participation. However, it was discovered at that time that literature was scarce on whether these divided PT sessions were equal or superior to the typical sessions. Nor was there any substantial literature on whether shorter duration higher frequency sessions were better tolerated by the inpatient. The purpose of this prospective randomized non-blinded controlled study is to compare outcomes of COVID inpatients receiving one 30 minute daily session of PT to patients receiving two 15 minute daily sessions of PT.
In order to obtain high quality data on level of mobility during hospitalization, two separate scoring systems will be used: The AMPAC and JH-HLM scores. These two scoring systems have been selected for their wide acceptance in both the physiatry and physical therapy communities, and due to having confirmed inter-rater reliability and validity. These scores will be calculated by the physical therapist on initial evaluation, and then again on every session up until discharge. The physical therapy team at this community hospital have already received extensive education on the utilization of both of these scoring tools.
The rationale for this study is to determine whether shorter duration (15 minute) higher frequency sessions (2x a day) are better tolerated than the standard 30-minute session. We hypothesize that shorter duration higher frequency sessions are superior to standard inpatient PT sessions in terms of patient tolerance and change in mobility scores from admission to discharge. Supporting evidence is based on previous observation and from a recent survey given to 19 physical therapists actively working with COVID-19 inpatients at White plains Hospital: Healthier patients have a higher tolerance of the 30 minute sessions, and sicker patients have a poor tolerance of the 30 minute sessions.
In order to obtain high quality data on level of mobility during hospitalization, two separate scoring systems will be used: The AMPAC and JH-HLM scores. These two scoring systems have been selected for their wide acceptance in both the physiatry and physical therapy communities, and due to having confirmed inter-rater reliability and validity. These scores will be calculated by the physical therapist on initial evaluation, and then again on every session up until discharge. The physical therapy team at this community hospital have already received extensive education on the utilization of both of these scoring tools.
The rationale for this study is to determine whether shorter duration (15 minute) higher frequency sessions (2x a day) are better tolerated than the standard 30-minute session. We hypothesize that shorter duration higher frequency sessions are superior to standard inpatient PT sessions in terms of patient tolerance and change in mobility scores from admission to discharge. Supporting evidence is based on previous observation and from a recent survey given to 19 physical therapists actively working with COVID-19 inpatients at White plains Hospital: Healthier patients have a higher tolerance of the 30 minute sessions, and sicker patients have a poor tolerance of the 30 minute sessions.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
COVID-19
Cardiopulmonary Disease
Weakness, Muscle
Hypoxia
Debility Due to Disease
Eligibility Criteria
Inclusion Criteria:
* Ages 18-89.
* positive COVID19 status as confirmed by at least one positive nasopharyngeal/oropharyngeal swab or chest CT.
* PT referral placed and patient seen by PT within 72 hours of admission.
Exclusion Criteria:
* Patients who were deemed unable to actively participate in therapy due to poor cognitive status or being medically unstable.
* Patients who are unable to give consent.
* Patient who are bedbound at baseline.
* Patient who are not fluent in English or Spanish (a Spanish version of consent form will be made available)?
* Ages 18-89.
* positive COVID19 status as confirmed by at least one positive nasopharyngeal/oropharyngeal swab or chest CT.
* PT referral placed and patient seen by PT within 72 hours of admission.
Exclusion Criteria:
* Patients who were deemed unable to actively participate in therapy due to poor cognitive status or being medically unstable.
* Patients who are unable to give consent.
* Patient who are bedbound at baseline.
* Patient who are not fluent in English or Spanish (a Spanish version of consent form will be made available)?
Inclusion Criteria
Inclusion Criteria:
* Ages 18-89.
* positive COVID19 status as confirmed by at least one positive nasopharyngeal/oropharyngeal swab or chest CT.
* PT referral placed and patient seen by PT within 72 hours of admission.
* Ages 18-89.
* positive COVID19 status as confirmed by at least one positive nasopharyngeal/oropharyngeal swab or chest CT.
* PT referral placed and patient seen by PT within 72 hours of admission.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
89 Years
Minimum Age
18 Years
NCT Id
NCT04844307
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2021-12937
Overall Status
Withdrawn
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Comparing COVID-19 Inpatient Outcomes When Treated With a Twice-a-day 15- Minute PT Program Versus a Once-a-day-30-minute PT Program
Primary Outcomes
Outcome Description
Patient tolerance will be recorded in minutes at end of each PT session in each group.
Outcome Measure
Patient tolerance
Outcome Time Frame
Through completion of study, an average of 1 year
Outcome Description
Mobility scores including Activity Measure for Post Acute Care (AMPAC) and Johns Hopkins Highest Level of Mobility (JH-HLM) will be recorded at end of each PT session. The change in scores from admission to discharge will be determined and recorded once patient is discharged.
Outcome Measure
Change in mobility scores from admission to discharge
Outcome Time Frame
Through completion of study, an average of 1 year
Secondary Outcomes
Outcome Description
Disposition possibilities include home, home with services, acute rehab, subacute rehab or skilled nursing facility, LTACH, transfer to another acute care hospital, hospice/home with hospice, expired.
Outcome Time Frame
Through completion of study, an average of 1 year
Outcome Measure
Disposition
Outcome Description
Total length of stay in the hospital will be determined based on date of admission and date of discharge from acute care hospital.
Outcome Time Frame
Through completion of study, an average of 1 year
Outcome Measure
Hospital Length of Stay
Start Date
Start Date Type
Estimated
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
89
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Anupama Kurra
Investigator Email
akurra@montefiore.org
Investigator Phone