Optimizing Outcomes With Physical Therapy Treatment for IndividuALs Surviving an ICU Admission for Covid-19 (OPTIMAL)

Optimizing Outcomes With Physical Therapy Treatment for IndividuALs Surviving an ICU Admission for Covid-19 (OPTImAL) - a Single Center Prospective Study

Introduction: Survivors of acute respiratory failure develop persistent muscle weakness and deficits in cardiopulmonary endurance combining to limit physical functioning. Early data from the Covid-19 pandemic suggest a high incidence of critically ill patients admitted to intensive care units (ICU) will require mechanical ventilation for acute respiratory failure. Covid-19 patients surviving an admission to the ICU are expected to suffer from physical and cognitive impairments that will limit quality of life and return to pre-hospital level of functioning. In this present study, the investigators will evaluate the safety and feasibility of providing a novel clinical pathway combining ICU after-care at an ICU Recovery clinic with physical therapy interventions.

Methods and Analysis: In this single-center, prospective (pre, post cohort) trial in patients surviving ICU admission for Covid-19. The investigators hypothesize that this novel combination is a) safe and feasible to provide for patients surviving Covid-19; b) improve physical function and exercise capacity measured by performance on 6-minute walk test and Short Performance Physical battery; and c) reduce incidence of anxiety, depression and post-traumatic stress assessed with Hospital Anxiety and Depression Scale and the Impact of Events Scale-revised. Safety will be assessed by pooled adverse events and reason for early termination of interventions. Feasibility will be assessed by rate of adherence and attrition. Repeated measures ANOVA will be utilized to assess change in outcomes from at first ICU Recovery Clinic follow-up (2-weeks) and 3- and 6-months post hospital discharge.

Ethics and Dissemination: The trial has received ethics approval at the University of Kentucky and enrollment has begun. The results of this trial will support the feasibility of providing ICU follow-up and physical therapy interventions for patients surviving critical illness for Covid-19 and may begin to support effectiveness of such interventions. Investigators plan to disseminate trial results in peer-reviewed journals, as well as presentation at physical therapy and critical care national and international conferences.

Study Overview

• Status: Completed
• Conditions: Covid-19; Critical Illness; Muscle Weakness; Post Intensive Care Unit Syndrome
• Intervention / Treatment: Other: ICU Recovery + Physical Therapy

Detailed Description

ICU Recovery Clinic is standard of care for patients surviving a critical illness in the Medical ICU at the University of Kentucky. The ICU Recovery Clinic includes a transdisciplinary team with input from five disciplines that provide coordinated outpatient care with a focus on medical issues, medication management, nutrition, sleep disruption, and any issues related to post-intensive care syndrome such as anxiety, depression, PTSD, cognitive dysfunction and physical impairments.

Individualized physical therapy treatment: After the initial ICU recovery clinic appointment patients will begin their 8-week physical therapy program which will be delivered 1-2 times per week in a supervised 1:1 session and supplemented with 3 days of unsupervised home exercises and walking program on days not participating in physical therapy sessions. Supervised sessions will be run by a physical therapist (>20 years of experience in ICU and pulmonary rehabilitation) either face to face in outpatient setting or through telemedicine using video consultation platforms for patients unable to attend appointments due to transmission risk, transportation issues, or geographically living >45 miles from clinic. Prior to commencing the first treatment session patients will complete baseline testing to inform the starting parameters (frequency, intensity, repetitions) based on performance in physical tests such as 6MWT and muscle strength testing. The patient will receive an individualized and tailored physical therapy treatment, which will be targeted towards increasing their aerobic fitness, muscle strength and functional ability.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients (>18 years of age) surviving an ICU admission with laboratory confirmed Covid-19.

Exclusion Criteria:

• pre-existing neurological or orthopedic injury, disease, or condition that would prevent participation in exercise interventions.
• patient not ambulatory prior to hospitalization
• patient not expected to survivor 90 days after hospitalization
• pregnant
• prisoner

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ICU followup + physical therapy; Patients surviving ICU admission for Covid-19 will receive ICU follow-up care in an ICU Recovery Clinic plus 8 weeks of physical therapy interventions. ICU Recovery Clinic is standard of care for patients surviving medical ICU admission at University of Kentucky with potential to attend in person or complete through telemedicine up to 5 appointments in the first year after hospital discharge. Physical therapy interventions completed at an outpatient pulmonary rehabilitation center or through telemedicine is not currently standard of care for patients in the short-term recovery phase (1-6 months after hospital discharge) after critical illness.

Other: ICU Recovery + Physical Therapy; Physical therapy interventions will be supervised by a physical therapist (>20 years of experience in ICU and pulmonary rehabilitation). Potential interventions include endurance/aerobic training (treadmill training, upper and lower extremity ergometer, and recumbent step machine), upper and lower extremity resistance strength training, balance training, functional movement training, and education. If the interventions are providing in the home environment the exercises will be completed through Zoom, video communications app. Home-based interventions will include seated and standing exercise including resistance exercises (such as lifting small weights) and endurance (e.g. marching or stepping in place, repetitive sit-to-stand training). Physical therapist will provide verbal instructions for motivation and adherence to exercise interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (safety)	Incidence of adverse events, quantified by pain or discomfort that causes termination of interventions; a fall (with or without injury) during interventions or directly related to interventions such as fall due to fatigue; and physiologic event/abnormality that warrants termination of interventions or medical follow-up including bradycardia, tachycardia, and emergent hypertension	through study completion, an average of 3-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility (success of consent process, adherence, and attrition)	Feasibility will be assessed by the consent rate (number of patients agreed to participate/number of patients approached for consent) and adherence attendance measured by the percentage of sessions patient participated divided total number of scheduled appointments. Adherence will also be prospectively assessed by total duration of exercise, dosage and intensity of exercises as described above. Attrition will be quantified by number of patients lost to follow-up.	through study completion, an average of 3-months
Six minute walk test	Distance walked on six-minute walk test performed in line with the ATS/ERS Guidelines as measure of exercise capacity	Assessed at baseline, and repeated 3- and 6-months post hospital discharge
Short Performance Physical Battery	Short Performance Physical Battery (SPPB) is a performance-based physical function test with components of balance, repetitive five times sit-to-stand for time, and 4-meter habitual gait speed. Higher scores on SPPB indicate better physical function.	Assessed at baseline, and repeated 3- and 6-months post hospital discharge
Quality of life (EQ-5DL)	Health-related quality of life (HRQoL) will be measured by self-report questionnaire, the Five Dimension Euro-Quality of Life (EQ-5D) that includes a visual analog scale with rating for overall HRQoL (0-100)	Assessed at baseline, and repeated 3- and 6-months post hospital discharge
Cognitive function	Cognitive function will be assessed by the Montreal Cognitive Assessment (MOCA) with <23/30 distinguishing mild cognitive impairment. If the patient participating in telemedicine through Zoom then the MOCA-Blind version will be completed.	Assessed at baseline, and repeated 3- and 6-months post hospital discharge
Anxiety and Depression	Anxiety and depression will be assessed with the Hospital Anxiety and Depression Scale (HADS), a fourteen-item scale with subset scores of >8/21 indicating anxiety or depression	Assessed at baseline, and repeated 3- and 6-months post hospital discharge
PTSD and distress	Distress and Post-traumatic stress disorder (PTSD) will be assessed through the Impact of Events Scale-Revised (IES-R), a 22-item self-report measure, with scores >35/88 recommending provisional diagnosis of PTSD	Assessed at baseline, and repeated 3- and 6-months post hospital discharge
Return to work	For patients previously employed, the return to work will be assessed using the self-report survey instrument designed for ICU follow-up	Assessed at baseline, and repeated 3- and 6-months post hospital discharge
Secondary complication	Readmission rate and morality with be assessed	Assessed 3 and 6-months post hospital discharge

Collaborators and Investigators

• Sponsor: University of Kentucky
• Collaborators: Ashley Montgomery-Yates
• Investigators: Principal Investigator: Kirby P Mayer, PhD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): May 5, 2021
• Study Completion (Actual): May 5, 2021

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Neurologic Manifestations; Disease Attributes; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; COVID-19; Muscle Weakness; Critical Illness
• Other Study ID Numbers: 59097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No