Muscle Recovery After Critical Illness

NCT05537298 | Recruiting

• 3 other identifiers: 774075K23AR079583R01AR081002
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

ICU Acquired Weakness; Post Intensive Care Unit Syndrome; Muscle Weakness; Critical Illness

Keywords

skeletal muscle; physical function

Outcome Measures

Primary Outcomes (3)

• Physical function

  Short Physical Performance Battery

  the change from baseline to 12-months

• Mitochondrial function

  muscle mitochondrial respirometry

  the change from baseline to 12-months

• Muscle power

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

  the change from baseline to 12-months

Secondary Outcomes (7)

• Physical activity

  the change from baseline to 12-months

• Functional mobility

  the change from baseline to 12-months

• Cardiopulmonary endurance / exercise capacity

  the change from baseline to 12-months

• self-reported health-related quality of life

  the change from baseline to 12-months

• Muscle strength

  the change from baseline to 12-months

Study Arms (2)

Survivor

Patients (n = 209) surviving critical illness will be enrolled to longitudinal, observational study examining muscle strength, power, and fatigue as well as physical function at hospital discharge and repeated at 3-, 6-, and 12-month following. A subset of individuals (n =32) will undergo muscle biopsies and blood will be collected.

Control

A group of healthy controls will be recruited to serve as comparator to measures of strength, power, physical function, and muscle tissue analyses. Controls will participate in a one-time assessment.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to ICU for critical illness and expected to survive

You may qualify if:

• adult (\>18 y/o)
• admission for sepsis or acute respiratory failure with at least 72 hour stay in ICU

You may not qualify if:

• acute or chronic neurologic condition
• acute or chronic orthopedic condition preventing strength/functional testing
• patients who were not ambulatory prior to ICU admission
• patients not expected to survive \~6months after admission

Sponsors & Collaborators

• Kirby Mayer: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• Oklahoma Medical Research Foundation: collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35005, United States

ACTIVE NOT RECRUITING

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73113, United States

ACTIVE NOT RECRUITING

Related Publications (1)

• Gonzalez-Seguel F, Summers LA, Fresenko LE, Long DE, Scott LN, Slone SA, Shankara Bhaktula S, Wen Y, Miller BF, Morris PE, Salyer AL, Kalema AG, Montgomery-Yates AA, Dupont-Versteegden EE, Mayer KP; TRACER study group Collaborators. Trajectories of Recovery after ACutE and cRitical illness (TRACER): a prospective observational study protocol. BMJ Open. 2025 Nov 19;15(11):e108885. doi: 10.1136/bmjopen-2025-108885.

  PMID: 41263932 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and muscle tissue will be collected from a subset of individuals (n = 32) at three time-points in recovery.

MeSH Terms

Conditions

Muscle Weakness; Critical Illness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Disease Attributes

Study Officials

• Kirby P Mayer, PhD

  University of Kentucky

  STUDY DIRECTOR

Central Study Contacts

Kirby P Mayer, PhD

CONTACT

859-218-0596; kpmaye2@uky.edu

Doug Long, MS

CONTACT

859-32-5438; delong2@uky.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: September 13, 2022
• Study Start: October 18, 2022
• Primary Completion (Estimated): July 2, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

US (3)