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Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older ICU Survivors

ConditionsCritical IllnessSarcopeniaICU Acquired Weakness
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age60-99
SponsorUniversity of Maryland, Baltimore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

LTACH admission within 72 hours

Age ≥ 60 years old

Prior ICU stay ≥ 2 weeks

Able to follow commands in English

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: UC onlyNo intervention 0 interventions
Group B: MRP+HPRO+NMES+UCActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Muscle mass

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

Time frame
Days 0 to 14 to 28
2

Change in Muscle strength

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

Time frame
Days 0, 7, 14, 21 and 28
3

Change in Systemic Inflammation

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

Time frame
Days 0, 7, 14, 21 and 28

Secondary outcomes

1

Change in Functional status - SPPB

Functional status will be assessed by using the Short Physical Performance Battery (SPPB)

Time frame
Days 0, 7, 14, 21 and 28
2

Change in Functional status - FSS-ICU

Functional status will be assessed by using the Functional Status Score in the ICU (FSS-ICU).

Time frame
Days 0, 7, 14, 21 and 28
3

Change in Mobility status - ICU mobility Scale

Mobility status will be assessed weekly using the 1-item ICU Mobility Scale weekly in those physically capable.

Time frame
Days 0, 7, 14, 21 and 28
4

Change in Mobility status - 6 minute walk distance

Mobility status will be assessed weekly using the total 6 Minute Walk distance in those physically capable.

Time frame
Days 0, 7, 14, 21 and 28

Other outcomes

Sponsors and contacts

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

University of Maryland, Baltimore

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: