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NCT02566590 · ClinicalTrials.gov registry record · NA

Preventing the Loss of Muscle and Function in Hospitalized Older Adults

A NA study, sponsored by University of Utah.

Completed
Registry status
NA
Development phase
20
Enrollment target

NCT02566590: Completed NA study, sponsored by University of Utah.

NCT02566590 is a NA study that has completed, run by University of Utah. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02566590, a NA study, has completed, sponsored by University of Utah.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target

Study Summary

One third of independent older adults over the age of 65y will be hospitalized for an acute medical illness, injury, or operative procedure. Unfortunately, 50% of these older adults will experience functional decline during their hospital stay from the amount of time they are physically inactive and in bed. Following discharge, the functional deficits can persist for months and in many instances never return to pre-hospitalization levels thus compounding morbidity, health care costs and dying. A classic consequence of short-term bed rest in older adults is the significant loss in skeletal muscle mass which underlies the accelerated leg strength deficits. The investigator has shown that an important mechanism of skeletal muscle loss is the inability of nutrients to stimulate a normal muscle protein synthesis response; a process highly regulated by the mammalian target of rapamycin signaling pathway (mTOR) and amino acid transporters. Day to day maintenance of force generating muscle tissue is dictated by anabolic stimulation from muscle contraction and essential amino acid ingestion. Therefore, anabolic interventions such as neuromuscular electrical stimulation (NMES) and high quality protein supplementation that contains a high proportion of essential amino acids (whey protein) may be promising approach to maintain leg muscle mass and strength in hospitalized older adults and prevent the long term consequences of repeated periods of short-term physical inactivity. The purpose of this study is to test in older adults if the combination of NMES and protein supplementation is capable of preserving muscle mass and strength and maintaining muscle nutrient anabolic sensitivity during bed rest. The investigators current hypotheses are that daily NMES and protein supplementation during 5-days of bed rest in older adults will: 1) preserve lower extremity muscle mass and strength and 2) maintain muscle nutrient anabolic sensitivity as measured by mTOR signaling and amino acid

Primary Outcome

Thigh lean mass (grams) will be measured by DEXA scan at baseline and after 5-days of bed rest. The change in thigh lean mass will be calculated between these two time points. This outcome will be measured for the Control and the NMES + PRO groups.

Interventions

  • DEVICE NMES
  • DIETARY_SUPPLEMENT Protein
  • DIETARY_SUPPLEMENT non-protein placebo supplement

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2015-01
Est. Completion 2016-12
Phase NA
University of Utah

818 total trials

What the finished NCT02566590 record still lists

NCT02566590 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 3 interventions - of which NMES is the first listed.

NCT02566590 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02566590 about?

NCT02566590 is a clinical study titled "Preventing the Loss of Muscle and Function in Hospitalized Older Adults". One third of independent older adults over the age of 65y will be hospitalized for an acute medical illness, injury, or operative procedure. Unfortunately, 50% of these older adults will experience functional decline during their hospital stay from the amount of time they are physically inactive and...

What is the current status of trial NCT02566590?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2015-01. Estimated completion is 2016-12.

What interventions are being tested in trial NCT02566590?

The interventions under investigation include: NMES (DEVICE), Protein (DIETARY_SUPPLEMENT), non-protein placebo supplement (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT02566590?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02566590's enrollment target sits among peer trials

20 1768th of 2000 higher than 140 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02566590, the US trial registry maintained by the National Library of Medicine. NCT02566590 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.