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Recovery of Physical Function After Critical Illness In Older Adults

NCT ID: NCT07225257

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-05-31

Study Completion Date

2031-12-31

Brief Summary

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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.

Detailed Description

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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:

Aim 1: Determine the long-term trajectory of muscle strength, physical function and ADL recovery in ICU survivors. Patients (n = 150) will participate in a battery of tests to determine muscle and physical function aligned with self-reported measures of ADLs and quality of life at hospital discharge, 3-, 6-, 12-, and 24-months post.

Aim 2: Assess cellular changes in skeletal muscle in ICU survivors contributing to long-term physical dysfunction. In a subgroup of patients enrolled in Aim 1, muscle biopsies will be collected at baseline and long-term follow-up to determine oxidative stress, mitochondrial function, and cellular senescence.

Conditions

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Sepsis Acute Lung Injury(ALI)

Keywords

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sepsis acute respiratory failure intensive care unit Acquired muscle weakness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RETURN

Survivors of critical illness

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Kentucky

OTHER

Sponsor Role lead

Responsible Party

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Kirby Mayer

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kirby P Mayer, DPT, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky, Lexington, Kentucky 40536

Lexington, Kentucky, United States

Site Status

Countries

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United States

Central Contacts

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Doug Long, MS

Role: CONTACT

Phone: 859-218-0596

Email: [email protected]

Kirby P Mayer, DPT, Ph.D.

Role: CONTACT

Phone: 859-218-0596

Email: [email protected]

Facility Contacts

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Louisa A Summers, Ph.D.

Role: primary

Doug Long, MS

Role: backup

Other Identifiers

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106867

Identifier Type: -

Identifier Source: org_study_id