Conventional early exercise and mobility interventions for Intensive Care Unit Acquired Weakness

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Intensive Care Unit Acquired WeaknessConventional early exercise and mobility interventions - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effects of exercise, early mobilization, and functional stimulation on muscle mass, strength, physical function, and patient-reported disability in ICU patients.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Baseline (within 24 hours of enrollment), weekly in the ICU (up to a maximum of 28 days), at ICU and hospital discharge (an average of 11 and 15 days after admission, respectively), and at 90 days, 6 months, and 1 year post ICU discharge

Day 15
Cognition
Year 1
Quality of life
Day 28
Percent change of rectus femoris cross-sectional area
Physical function
Year 1
Muscle strength
Day 28
Diaphragm muscle thickness
Day 11
ICU length of stay
Day 10
Mechanical ventilation
Day 15
Hospital length of stay

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Conventional early exercise and mobility interventions
1 of 2
Functional electrical stimulation assisted supine cycling
1 of 2

Active Control

Experimental Treatment

32 Total Participants · 2 Treatment Groups

Primary Treatment: Conventional early exercise and mobility interventions · No Placebo Group · N/A

Functional electrical stimulation assisted supine cyclingExperimental Group · 2 Interventions: Functional electrical stimulation assisted supine cycling (FESC), Conventional early exercise and mobility interventions · Intervention Types: Device, Other
Conventional early exercise and mobility interventions
Other
ActiveComparator Group · 1 Intervention: Conventional early exercise and mobility interventions · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (within 24 hours of enrollment), weekly in the icu (up to a maximum of 28 days), at icu and hospital discharge (an average of 11 and 15 days after admission, respectively), and at 90 days, 6 months, and 1 year post icu discharge

Who is running the clinical trial?

Fresno Community Hospital and Medical CenterLead Sponsor
2 Previous Clinical Trials
111 Total Patients Enrolled
Western University of Health SciencesOTHER
19 Previous Clinical Trials
1,225 Total Patients Enrolled
Paul D Smith, PT, DPTPrincipal InvestigatorCommunity Medical Centers

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are admitted to the ICU with a predicted ICU length of stay ≥ 4 days.
You are able to perform physical outcome measures pre-morbidly (with or without an assisted device).