Clinical trial NCT04412330: Optimizing Outcomes With Physical Therapy Treatment for IndividuALs Surviving an ICU Admission for Covid-19
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
Overall status: COMPLETED
Phase: NA
Conditions: Covid-19
Critical Illness
Post Intensive Care Unit Syndrome
Muscle Weakness
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Ashley Montgomery-Yates
First posted: 2020-06-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adverse events (safety)
timeFrame: through study completion, an average of 3-months
Secondary outcomes:
measure: Feasibility (success of consent process, adherence, and attrition)
timeFrame: through study completion, an average of 3-months
measure: Six minute walk test
timeFrame: Assessed at baseline, and repeated 3- and 6-months post hospital discharge
measure: Short Performance Physical Battery
timeFrame: Assessed at baseline, and repeated 3- and 6-months post hospital discharge
measure: Quality of life (EQ-5DL)
timeFrame: Assessed at baseline, and repeated 3- and 6-months post hospital discharge
measure: Cognitive function
timeFrame: Assessed at baseline, and repeated 3- and 6-months post hospital discharge
measure: Anxiety and Depression
timeFrame: Assessed at baseline, and repeated 3- and 6-months post hospital discharge
measure: PTSD and distress
timeFrame: Assessed at baseline, and repeated 3- and 6-months post hospital discharge
measure: Return to work
timeFrame: Assessed at baseline, and repeated 3- and 6-months post hospital discharge
measure: Secondary complication
timeFrame: Assessed 3 and 6-months post hospital discharge
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Kirby P Mayer, PhD
role: PRINCIPAL_INVESTIGATOR
References: