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Comparing Inpatient COVID-19 Outcomes in 2 Different PT Dosing Groups (CCPT)

Primary Purpose

COVID-19, Cardiopulmonary Disease, Weakness, Muscle

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Shorter duration higher frequency PT
Standard PT
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)?

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Standard PT group

    Divided session PT group

    Arm Description

    The standard PT group (control) will be receiving the standard 30 minute PT sessions 5 days a week. There will be no variations from standard inpatient PT treatment except that subjects may receive more days of PT than patients who are not participating in study.

    The divided session PT group (experimental) will be receiving 15 minute sessions twice a day, five days a week. The total number of minutes of PT time per day/week will be identical to the standard PT group, but divided into shorter and more frequent sessions.

    Outcomes

    Primary Outcome Measures

    Patient tolerance
    Patient tolerance will be recorded in minutes at end of each PT session in each group.
    Change in mobility scores from admission to discharge
    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.

    Secondary Outcome Measures

    Disposition
    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.
    Hospital Length of Stay
    Total length of stay in the hospital will be determined based on date of admission and date of discharge from acute care hospital.

    Full Information

    First Posted
    March 23, 2021
    Last Updated
    February 3, 2022
    Sponsor
    Montefiore Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04844307
    Brief Title
    Comparing Inpatient COVID-19 Outcomes in 2 Different PT Dosing Groups
    Acronym
    CCPT
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Upon further review it has come to the PI's attention that the study may want no longer be very effective since most of our Covid patients are being discharged pretty quickly now that the treatments are so effective.
    Study Start Date
    October 2021 (Anticipated)
    Primary Completion Date
    February 2022 (Anticipated)
    Study Completion Date
    February 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Montefiore Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19, Cardiopulmonary Disease, Weakness, Muscle, Hypoxia, Debility Due to Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard PT group
    Arm Type
    Active Comparator
    Arm Description
    The standard PT group (control) will be receiving the standard 30 minute PT sessions 5 days a week. There will be no variations from standard inpatient PT treatment except that subjects may receive more days of PT than patients who are not participating in study.
    Arm Title
    Divided session PT group
    Arm Type
    Experimental
    Arm Description
    The divided session PT group (experimental) will be receiving 15 minute sessions twice a day, five days a week. The total number of minutes of PT time per day/week will be identical to the standard PT group, but divided into shorter and more frequent sessions.
    Intervention Type
    Other
    Intervention Name(s)
    Shorter duration higher frequency PT
    Intervention Description
    The standard PT session (30 mins) will be divided into two 15 minute sessions spread out during the day. Therefore, the total number of minutes of PT will not vary from the standard.
    Intervention Type
    Other
    Intervention Name(s)
    Standard PT
    Intervention Description
    The standard PT session is 30 minutes once daily. It routinely involves exercises designed to strengthen and increase mobility of the patient such as bed mobility, transfers, and ambulation. In this study group there will be no variation from this standard treatment.
    Primary Outcome Measure Information:
    Title
    Patient tolerance
    Description
    Patient tolerance will be recorded in minutes at end of each PT session in each group.
    Time Frame
    Through completion of study, an average of 1 year
    Title
    Change in mobility scores from admission to discharge
    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.
    Time Frame
    Through completion of study, an average of 1 year
    Secondary Outcome Measure Information:
    Title
    Disposition
    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.
    Time Frame
    Through completion of study, an average of 1 year
    Title
    Hospital Length of Stay
    Description
    Total length of stay in the hospital will be determined based on date of admission and date of discharge from acute care hospital.
    Time Frame
    Through completion of study, an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    89 Years
    Accepts Healthy Volunteers
    No
    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)?
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anupama Kurra, MD
    Organizational Affiliation
    Montefiore Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Comparing Inpatient COVID-19 Outcomes in 2 Different PT Dosing Groups

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