At a glance

ClinicalIndex Comparison Record

N/ACompleted· 24 enrolled

Drug / intervention

cycle ergometrydevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02963558

NCT02963558N/ACompleted

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ASPIRE: A Study Promoting Critical Illness Recovery in the Elderly

Wake Forest University Health Sciences·interventional·Posted Nov 15, 2016·Updated Oct 18, 2024

In Brief

A clinical study evaluating cycle ergometry for Acute Respiratory Distress Syndrome and 2 related conditions. Completed, enrolled 24 participants across 1 site.

Detailed Summary

This proposal will test the hypothesis that EARLY application of a novel early rehabilitation therapy in critically ill patients will improve functional outcomes, and change the functional trajectory of this population. A pilot study of early mobilization with a cycle ergometer will be performed and translate into humans the pre-clinical mechanisms that may mediate the effects of early mobility. A second phase of the study was added in September 2019, which will focus on clinical outcomes.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAcute Respiratory Distress Syndrome, Critical Illness, Critical Care

CountriesUnited States

CollaboratorsNational Institute on Aging (NIA), National Center for Advancing Translational Sciences (NCATS)

Timeline

N/ACompletedFinished

2017201820192020202120222023202420252026

First PostedNov 2016

Enrollment StartMay 2017

Primary CompletionSep 2020

Study CompletionMar 2021

TodayJul 2026

First PostedNov 15, 2016

Enrollment StartMay 30, 2017

Primary CompletionSep 11, 2020

Study CompletionMar 11, 2021

TodayJul 2, 2026

Enrollment to primary: 3.3 yearsPosted 9.6 years ago

Interventions

cycle ergometrydevice

The cycler will provide 3 different possible modes of cycling-passive, active-assisted, and active. The subject will start with passive cycling and may progress to active-assisted and active cycling.