MedTrace Logo

Assessing The Effects of Exercise, Protein, and Electric Stimulation On Intensive Care Unit Patients Outcomes

NCT02509520 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-07-03

No results posted yet for this study

Summary

Elderly patients who experience a prolonged ICU stay are at high risk for developing post intensive care unit syndrome (PICS), a serious medical condition manifested by loss of muscle mass, weakness, malnutrition and neurocognitive decline. PICS often leads to chronic disability, prolonged mechanical ventilation and the need for costly extended stays in long term care facilities (LTCs). The investigators' preliminary study shows attempts at rehabilitating patients who have already developed PICS are minimally effective, resulting in only modest improvements in functionality. This project will determine the effects of mobility-based physical rehabilitation (MPR) combined with neuromuscular electric stimulation (NMES) and high protein supplementation (HPRO) early in a patients ICU stay on preventing PICS related musculoskeletal and functional deficits, and improving clinical outcomes.

Conditions

Interventions

DIETARY_SUPPLEMENT

MPR and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES)

The MPR provides strength and cardiopulmonary endurance training, which consist of exercises to promote function movements. Intensity is based on patient's hemodynamic responses and subjective report using Modified Borg Dyspnea Scale. Intensity, duration, or type of activity will be modified each session to achieve a moderately intense physiologic response. The NMES protocol requires self-adhesive surface electrodes be placed on quadriceps muscles and lower leg bilaterally, twice daily. This protocol is based on prior NMES protocols used to stimulate muscle protein synthesis in older diabetic patients, preserve muscle mass in intensive care patients and increase strength in older adults after knee replacement. The HPRO intervention is based on caloric needs, calculated using validated equations to maintain positive nitrogen balance. Protein will be supplemented as isolated amino acids twice/day to deliver \~15g of essential amino acids per serving, with a goal of 1.6 g/kg/day.

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-01
Primary Completion
2026-05-01
Completion
2026-05-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02509520 on ClinicalTrials.gov