Recovery of Physical Function After Critical Illness In Older Adults

NCT07225257 | Not Yet Recruiting DMC

• 1 other identifier: 106867
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study is a prospective, observational study assessing the recovery of muscle and physical function in patients surviving critical illness (n =150) at hospital discharge (baseline) and repeated serially. Patients will be enrolled after life-saving modalities have been weaned near hospital discharge. Patients will participate in testing at baseline, 3-, 6-, 12-, and 24-months after hospital discharge. In a subset of patients (n = 18), muscle biopsies will be performed at baseline and then repeated once at either 12- or 24-months after hospital discharge.

Conditions

Sepsis; Acute Lung Injury(ALI)

Keywords

sepsis; acute respiratory failure; intensive care unit; Acquired muscle weakness

Outcome Measures

Primary Outcomes (2)

• Muscle Strength measured by Chair Rise Test

  Performance on 5x sit to stand test will be the primary outcome measure representing lower extremity muscle strength ; measured as time in seconds to complete 5 repetitive sit-stands.

  Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.

• Functional Capacity

  The 6-minute walk test (6MWT), which measures the distance a participant can walk in six minutes and serves as an indicator of cardiopulmonary function, will be used as a primary outcome.

  Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.

Secondary Outcomes (13)

• Muscle morphology # 1

  Percent change from baseline to 12 months

• Muscle morphology #2

  Percent change from baseline to 12 months

• Lower-extremity Muscle Power

  Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.

• Muscle Size and Quality measured by Ultrasound

  Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.

• Activities of Daily Living (ADL)

  Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.

Study Arms (1)

RETURN

Survivors of critical illness

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with a diagnosis of acute lung injury or sepsis who have survived an Intensive Care Unit admission for at least 72 hours.

You may qualify if:

• adult patients (≥40 years of age)
• patients who have survived an ICU admission of at least 72 hours
• diagnosis of acute lung injury or sepsis are eligible.

You may not qualify if:

• individuals who were not ambulatory prior to ICU admission,
• not expected to survive at least 6 months,
• have a new or pre-existing brain infarct, injury, or neurological condition with deficits preventing participation in physical testing,
• have a pre-existing geriatric syndrome that were confound recovery trajectory

Sponsors & Collaborators

• University of Kentucky: lead

Study Sites (1)

University of Kentucky, Lexington, Kentucky 40536

Lexington, Kentucky, 40536, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and muscle tissue

MeSH Terms

Conditions

Sepsis; Acute Lung Injury

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kirby P Mayer, DPT, Ph.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doug Long, MS

CONTACT

859-218-0596; delong2@uky.edu

Kirby P Mayer, DPT, Ph.D.

CONTACT

859-218-0596; kpmaye2@uky.edu

Study Design

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

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: November 6, 2025
• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: November 6, 2025

Record last verified: 2025-11

Locations

US (1)