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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04412330
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : June 24, 2020
Sponsor:
Collaborator:
Ashley Montgomery-Yates
Information provided by (Responsible Party):
Kirby Mayer, University of Kentucky

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.


Condition or disease Intervention/treatment Phase
Covid-19 Critical Illness Post Intensive Care Unit Syndrome Muscle Weakness Other: ICU Recovery + Physical Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Prospective study with one-treatment arm
Primary Purpose: Treatment
Official Title: Optimizing Outcomes With Physical Therapy Treatment for IndividuALs Surviving an ICU Admission for Covid-19 (OPTImAL) - a Single Center Prospective Study
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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.




Primary Outcome Measures :
  1. Adverse events (safety) [ Time Frame: through study completion, an average of 3-months ]
    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 :
  1. Feasibility (success of consent process, adherence, and attrition) [ Time Frame: through study completion, an average of 3-months ]
    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.

  2. Six minute walk test [ Time Frame: Assessed at baseline, and repeated 3- and 6-months post hospital discharge ]
    Distance walked on six-minute walk test performed in line with the ATS/ERS Guidelines as measure of exercise capacity

  3. Short Performance Physical Battery [ Time Frame: Assessed at baseline, and repeated 3- and 6-months post hospital discharge ]
    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.

  4. Quality of life (EQ-5DL) [ Time Frame: Assessed at baseline, and repeated 3- and 6-months post hospital discharge ]
    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)

  5. Cognitive function [ Time Frame: Assessed at baseline, and repeated 3- and 6-months post hospital discharge ]
    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.

  6. Anxiety and Depression [ Time Frame: Assessed at baseline, and repeated 3- and 6-months post hospital discharge ]
    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

  7. PTSD and distress [ Time Frame: Assessed at baseline, and repeated 3- and 6-months post hospital discharge ]
    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

  8. Return to work [ Time Frame: Assessed at baseline, and repeated 3- and 6-months post hospital discharge ]
    For patients previously employed, the return to work will be assessed using the self-report survey instrument designed for ICU follow-up

  9. Secondary complication [ Time Frame: Assessed 3 and 6-months post hospital discharge ]
    Readmission rate and morality with be assessed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04412330


Contacts
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Contact: Kirby P Mayer, PhD 859-323-1100 kpmaye2@uky.edu

Locations
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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Kirby Mayer, DPT, PhD(c)    859-323-3863    kpmaye2@uky.edu   
Contact: Evan Cassity, MS    8593233863      
Sponsors and Collaborators
University of Kentucky
Ashley Montgomery-Yates
Investigators
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Principal Investigator: Kirby P Mayer, PhD University of Kentucky
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Responsible Party: Kirby Mayer, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT04412330    
Other Study ID Numbers: 59097
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscle Weakness
Critical Illness
Disease Attributes
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases