NCT05326633

Brief Summary

Older ICU survivors with ICU acquired weakness (ICUAW) are malnourished, sarcopenic, and functionally debilitated as a consequence of the high burden of comorbidities common in the elderly. To address the sequalae of critical illnesses, the investigators will perform a trial incorporating an intervention that combines mobility-based physical rehabilitation (MRP), high protein supplementation (HPRO), and neuromuscular electric stimulation (NMES). The investigators will then assess both clinical and functional outcomes and determine the relationship of disability with systemic inflammation.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P75+ for early_phase_1

Timeline
32mo left

Started Mar 2027

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 13, 2022

Completed
4.9 years until next milestone

Study Start

First participant enrolled

March 1, 2027

Expected
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2029

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2029

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

February 7, 2022

Last Update Submit

April 30, 2026

Conditions

Critical IllnessSarcopeniaICU Acquired Weakness

Keywords

ICU Acquired WeaknessCritical CareLong Term Acute Care HospitalProteinNeuromuscular electric stimulationPhysical RehabilitationGeriatric population

Outcome Measures

Primary Outcomes (3)

  • Change in Muscle mass

    Muscle mass will be measured by lower extremity muscle CT scans to calculate muscle volume and cross sectional area.

    Days 0 to 14 to 28

  • Change in Muscle strength

    Handgrip strength obtained using a hand grip dynamometer and manual muscle testing using hand held dynamometer

    Days 0, 7, 14, 21 and 28

  • Change in Systemic Inflammation

    Quantitative analysis of CRP, IFN-γ, IL-1α, IL-1β, IL-6, and IL-8.

    Days 0, 7, 14, 21 and 28

Secondary Outcomes (6)

  • Change in Functional status - SPPB

    Days 0, 7, 14, 21 and 28

  • Change in Functional status - FSS-ICU

    Days 0, 7, 14, 21 and 28

  • Change in Mobility status - ICU mobility Scale

    Days 0, 7, 14, 21 and 28

  • Change in Mobility status - 6 minute walk distance

    Days 0, 7, 14, 21 and 28

  • Change in Mobility status - gait speed

    Days 0, 7, 14, 21 and 28

  • +1 more secondary outcomes

Study Arms (2)

UC only

NO INTERVENTION

LTACH control group receiving usual care (UC) only.

MRP+HPRO+NMES+UC

ACTIVE COMPARATOR

LTACH group receiving mobility based rehabilitation (MRP) + neuromuscular electric stimulation (NMES) + high protein supplementation (HPRO) + usual care (UC)

Combination Product: MRP and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES)

Interventions

MRP and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES)COMBINATION_PRODUCT

Mobility-based physical rehabilitation sessions performed 5 times/week by a study PT to provide strength and cardiopulmonary endurance training. High whey protein shakes prescribed to a total intake of 1.6-1.8 g/kg/d in 2 divided doses based on caloric needs. 2 x 30-minute lower extremity electric stimulation sessions/day, 5 times/wk performed by study PT.

MRP+HPRO+NMES+UC

Eligibility Criteria

Age60 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • LTACH admission within 72 hours
  • Age ≥ 60 years old
  • Prior ICU stay ≥ 2 weeks
  • Able to follow commands in English
  • Pre-ICU Barthel Index ≥ 70
  • Able to give consent
  • Able to perform physical therapy
  • All four limbs intact and mobile prior to LTACH admission

You may not qualify if:

  • Acute kidney injury with a glomerular filtration rate \<15 ml/min
  • Diagnosis of severe organ dysfunction including end stage liver disease or cirrhosis
  • Diagnosis of active cancer
  • Severe functional impairment or physical impairment to rehabilitation
  • Liver function tests \>2.5x normal limits
  • Chronic dementia or cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U of Maryland, Baltimore, Professional Schools IRB

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Critical IllnessSarcopenia

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and Symptoms

Central Study Contacts

Avelino C Verceles, M.D., M.S.

CONTACT

410-328-8141avercele@medicine.umaryland.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 7, 2022

First Posted

April 13, 2022

Study Start (Estimated)

March 1, 2027

Primary Completion (Estimated)

January 30, 2029

Study Completion (Estimated)

October 30, 2029

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)