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Behavioural Intervention

FESC for ICU Acquired Weakness

N/A
Waitlist Available
Led By Paul D Smith, PT, DPT
Research Sponsored by Fresno Community Hospital and Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Expected to receive mechanical ventilation > 48 hours
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (within 24 hours of enrollment), weekly in the icu (up to a maximum of 28 days), at icu discharge (an average of 11 days after admission), and at hospital discharge (an average of 15 days after admission)
Awards & highlights

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.

Who is the study for?
This trial is for ICU patients who are expected to be on mechanical ventilation for over 48 hours, aged 18 or older, likely to survive the ICU stay, and were able to move with or without help before being admitted. They should expect an ICU stay of at least 4 days. People with leg weakness from conditions like stroke, pregnant women, those with pacemakers or defibrillators, certain cancer patients, and individuals too large for the cycling equipment cannot join.Check my eligibility
What is being tested?
The study tests if adding functional electrical stimulation assisted supine cycling (FESC) to regular early exercise helps maintain muscle mass and strength in critically ill patients better than exercise alone. It also looks at how these methods affect physical function and patient-reported disability during their ICU stay.See study design
What are the potential side effects?
Potential side effects may include skin irritation where electrodes are placed for FESC. Since this intervention doesn't require active participation, risks are minimal but could involve discomfort associated with any form of physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are expected to use a breathing machine for more than 48 hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (within 24 hours of enrollment), weekly during icu admission (up to a maximum of 28 days), at icu discharge (an average of 11 days after admission), and at hospital discharge (an average of 15 days after admission)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (within 24 hours of enrollment), weekly during icu admission (up to a maximum of 28 days), at icu discharge (an average of 11 days after admission), and at hospital discharge (an average of 15 days after admission) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent change of rectus femoris cross-sectional area
Secondary outcome measures
Cognition
Diaphragm muscle thickness
Mechanical ventilation
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Functional electrical stimulation assisted supine cyclingExperimental Treatment2 Interventions
Patients will start functional electrical stimulation assisted supine cycling (FESC) within 48 hours of ICU admission and will undergo up to 1 hour of supine cycling daily, 5 days per week for 28 days, or until discharge from ICU.
Group II: Conventional early exercise and mobility interventionsActive Control1 Intervention
Patients will undergo standard ICU exercise and mobility interventions.

Find a Location

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
23 Previous Clinical Trials
1,431 Total Patients Enrolled
Paul D Smith, PT, DPTPrincipal InvestigatorCommunity Medical Centers

Media Library

Functional Electrical Stimulation Assisted Supine Cycling (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03554811 — N/A
Acquired Weakness Research Study Groups: Functional electrical stimulation assisted supine cycling, Conventional early exercise and mobility interventions
Acquired Weakness Clinical Trial 2023: Functional Electrical Stimulation Assisted Supine Cycling Highlights & Side Effects. Trial Name: NCT03554811 — N/A
Functional Electrical Stimulation Assisted Supine Cycling (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03554811 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research still open for participant recruitment?

"Affirmative. According to clinicaltrials.gov, this research endeavour – first posted on January 1st 2020 and most recently revised on August 16th 2021 – is currently searching for 32 participants across a single site."

Answered by AI

How many individuals are taking part in this experiment?

"Affirmative. The information displayed on clinicaltrials.gov reveals that this medical trial is currently recruiting participants, first posted in January 1st 2020 and last modified August 16th 2021. A total of 32 individuals are needed from one single site for the study to be successful."

Answered by AI
~6 spots leftby Mar 2025