NCT04412330: OPTIMAL

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

Completed NA Last updated 11 June 2021

What this trial tests

NA trial testing ICU Recovery + Physical Therapy in Covid-19 in 32 participants. Completed in 5 May 2021.

Timeline

1 May 2020

Primary endpoint
5 May 2021

5 May 2021

Quick facts

Lead sponsor	University of Kentucky
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	1 May 2020
Primary completion	5 May 2021
Estimated completion	5 May 2021
Sites	1 location across United States

Drugs / interventions tested

• ICU Recovery + Physical Therapy

Conditions studied

• Covid-19 — all drugs for Covid-19 →
• Critical Illness — all drugs for Critical Illness →
• Post Intensive Care Unit Syndrome — all drugs for Post Intensive Care Unit Syndrome →
• Muscle Weakness — all drugs for Muscle Weakness →

Sponsor

University of Kentucky

Who can join

18 and older, any sex, with Covid-19 or Critical Illness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety and Feasibility of an Interdisciplinary Treatment Approach to Optimize Recovery From Critical Coronavirus Disease 2019.
   Mayer KP, Parry SM, Kalema AG, Joshi RR, et al · · 2021 · cited 15× · PMID 34476403 · DOI 10.1097/cce.0000000000000516
2. SARS-Cov-2 Damage on the Nervous System and Mental Health.
   Boulkrane MS, Ilina V, Melchakov R, Arisov M, et al · · 2022 · cited 4× · PMID 34191699 · DOI 10.2174/1570159x19666210629151303