Muscle Recovery After Critical Illness

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorEsther Dupont-Versteegden

About this trial

The overarching goal of the proposed study is to determine the trajectories of physical recovery and cellular markers involved with the underlying failure to recover muscle after critical illness, while exploring which characteristics are associated with sustained physical disability. This proposal will examine muscle pathophysiology carefully aligned with physical function outcomes in order to longitudinally assess the recovery, or failed recovery, of muscle function in participants after critical illness:

1. to examine the recovery of muscle and physical function in ICU survivors through longitudinal assessments 2. to investigate the underlying cellular markers and mechanisms of muscle recovery in ICU survivors 3. to determine which cellular markers contribute to physical disability in ICU survivors up to 1 year after hospital admission

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adult (>18 y/o)

admission for sepsis or acute respiratory failure with at least 72 hour stay in ICU

Disqualifiers

patients who were not ambulatory prior to ICU admission

experienced >2 ICU admissions in the past year (chronic or recurrent critical illness due to the same or different reason

patients not expected to survive ~6months after admission

acute or chronic neurologic condition

Trial population

Patients admitted to ICU for critical illness and expected to survive

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

209 Participants
are grouped into 2 trial groups
Group A: Survivor
Group B: Control

Trial outcomes

Primary outcomes

1

Physical function

Short Physical Performance Battery

Time frame
the change from baseline to 12-months
2

Mitochondrial function

muscle mitochondrial respirometry

Time frame
the change from baseline to 12-months
3

Muscle power

lower-extremity muscle power (unilateral leg-press to record Watts)

Time frame
the change from baseline to 12-months

Secondary outcomes

1

Physical activity

actigraphy measuring steps per day

Time frame
the change from baseline to 12-months
2

Functional mobility

timed-up and go test

Time frame
the change from baseline to 12-months
3

Cardiopulmonary endurance / exercise capacity

6-minute walk test

Time frame
the change from baseline to 12-months
4

self-reported health-related quality of life

EuroQol-5Domains (EQ-5D) visual analog scale is a self-report of quality of life (0-100) with higher scores indicating a better perception of quality of life

Time frame
the change from baseline to 12-months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Esther Dupont-Versteegden

Lead sponsor

University of Kentucky

Sponsor institution

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Oklahoma Medical Research Foundation

Collaborator

University of Alabama at Birmingham

Collaborator