COVID-19CCPTNCT04844307
Comparing Inpatient COVID-19 Outcomes in 2 Different PT Dosing Groups
A study testing Shorter duration higher frequency PT and Standard PT in people with COVID-19 and Cardiopulmonary Disease, run by Montefiore Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- COVID-19, Cardiopulmonary Disease, Weakness, Muscle
- What is being tested?
- Shorter duration higher frequency PT and Standard PT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)?
About this study
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
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.
Read the 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.
- Being tested
- Shorter duration higher frequency PT, Standard PT
- Medical subject headings
- COVID-19, Pulmonary Heart Disease, Muscle Weakness, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shorter duration higher frequency PTOther
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.
Standard PTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard PT group | Active comparator | 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. Receives: Other: Standard PT |
| Divided session PT group | Experimental | 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. Receives: Other: Shorter duration higher frequency PT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient tolerance
Patient tolerance will be recorded in minutes at end of each PT session in each group.
Measured: Through completion of study, an average of 1 year
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.
Measured: Through completion of study, an average of 1 year
Secondary outcomes (2)
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.
Measured: Through completion of study, an average of 1 year
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.
Measured: Through completion of study, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study startOct 2021 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2022 (estimated)
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anupama Kurra, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844307
- Sponsor's protocol ID
- 2021-12937
- Acronym
- CCPT
- Status last verified
- Feb 2022
- First submitted
- 23 Mar 2021
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04844307
- Acronym / sponsor ID
- CCPT / 2021-12937
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard PT group | Active comparator | Other: Standard PTThe 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. |
| Divided session PT group | Experimental | Other: Shorter duration higher frequency PTThe 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)?
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shorter duration higher frequency PTThe 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. | Other | Divided session PT group |
| Standard PTThe 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. | Other | Standard PT group |
Primary outcome
Patient tolerance
Time frame: Through completion of study, an average of 1 year
Patient tolerance will be recorded in minutes at end of each PT session in each group.
Change in mobility scores from admission to discharge
Time frame: Through completion of study, an average of 1 year
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.
2 secondary outcomes
Disposition
Time frame: Through completion of study, an average of 1 year
Hospital Length of Stay
Time frame: Through completion of study, an average of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anupama Kurra, MD principal investigator
Montefiore Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Shorter duration higher frequency PT and Standard PT in people with COVID-19 and Cardiopulmonary Disease, run by Montefiore Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient tolerance (time frame: Through completion of study, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2022.