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

Primary Purpose

Covid-19, Critical Illness, Post Intensive Care Unit Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ICU Recovery + Physical Therapy
Sponsored by
University of Kentucky
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid-19

Eligibility Criteria

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

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

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICU followup + physical therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Six minute walk test
Distance walked on six-minute walk test performed in line with the ATS/ERS Guidelines as measure of exercise capacity
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.
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)
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.
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
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
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
Secondary complication
Readmission rate and morality with be assessed

Full Information

First Posted
May 12, 2020
Last Updated
June 8, 2021
Sponsor
University of Kentucky
Collaborators
Ashley Montgomery-Yates
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1. Study Identification

Unique Protocol Identification Number
NCT04412330
Brief Title
Optimizing Outcomes With Physical Therapy Treatment for IndividuALs Surviving an ICU Admission for Covid-19
Acronym
OPTIMAL
Official Title
Optimizing Outcomes With Physical Therapy Treatment for IndividuALs Surviving an ICU Admission for Covid-19 (OPTImAL) - a Single Center Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
May 5, 2021 (Actual)
Study Completion Date
May 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kentucky
Collaborators
Ashley Montgomery-Yates

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19, Critical Illness, Post Intensive Care Unit Syndrome, Muscle Weakness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Prospective study with one-treatment arm
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICU followup + physical therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
ICU Recovery + Physical Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adverse events (safety)
Description
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
Time Frame
through study completion, an average of 3-months
Secondary Outcome Measure Information:
Title
Feasibility (success of consent process, adherence, and attrition)
Description
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.
Time Frame
through study completion, an average of 3-months
Title
Six minute walk test
Description
Distance walked on six-minute walk test performed in line with the ATS/ERS Guidelines as measure of exercise capacity
Time Frame
Assessed at baseline, and repeated 3- and 6-months post hospital discharge
Title
Short Performance Physical Battery
Description
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.
Time Frame
Assessed at baseline, and repeated 3- and 6-months post hospital discharge
Title
Quality of life (EQ-5DL)
Description
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)
Time Frame
Assessed at baseline, and repeated 3- and 6-months post hospital discharge
Title
Cognitive function
Description
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.
Time Frame
Assessed at baseline, and repeated 3- and 6-months post hospital discharge
Title
Anxiety and Depression
Description
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
Time Frame
Assessed at baseline, and repeated 3- and 6-months post hospital discharge
Title
PTSD and distress
Description
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
Time Frame
Assessed at baseline, and repeated 3- and 6-months post hospital discharge
Title
Return to work
Description
For patients previously employed, the return to work will be assessed using the self-report survey instrument designed for ICU follow-up
Time Frame
Assessed at baseline, and repeated 3- and 6-months post hospital discharge
Title
Secondary complication
Description
Readmission rate and morality with be assessed
Time Frame
Assessed 3 and 6-months post hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirby P Mayer, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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