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临床试验/NCT04844307
NCT04844307撤回不适用

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

Montefiore Medical Center0 个研究点开始时间: 2021年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Patient tolerance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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)?

研究组 & 干预措施

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.

干预措施: Standard PT (Other)

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.

干预措施: Shorter duration higher frequency PT (Other)

结局指标

主要结局

Patient tolerance

时间窗: 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

时间窗: 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.

次要结局

  • Hospital Length of Stay(Through completion of study, an average of 1 year)
  • Disposition(Through completion of study, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

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