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

NCT04844307 | Withdrawn DMC

• 1 other identifier: 2021-12937
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19; Cardiopulmonary Disease; Weakness, Muscle; Hypoxia; Debility Due to Disease

Outcome Measures

Primary Outcomes (2)

• Patient tolerance

  Patient tolerance will be recorded in minutes at end of each PT session in each group.

  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.

  Through completion of study, an average of 1 year

Secondary Outcomes (2)

• Disposition

  Through completion of study, an average of 1 year

• Hospital Length of Stay

  Through completion of study, an average of 1 year

Study Arms (2)

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.

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.

Other: Shorter duration higher frequency PT

Interventions

Shorter duration higher frequency PT OTHER

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.

Divided session PT group

Standard PT OTHER

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.

Standard PT group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)?

Sponsors & Collaborators

• Montefiore Medical Center: lead

MeSH Terms

Conditions

COVID-19; Pulmonary Heart Disease; Muscle Weakness; Hypoxia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Signs and Symptoms, Respiratory

Study Officials

• Anupama Kurra, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 14, 2021
• Study Start: October 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share