Recruiting

Functional Stimulation

Sponsor:

Fresno Community Hospital and Medical Center

Code:

NCT03554811

Conditions

ICU Acquired Weakness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Functional electrical stimulation assisted supine cycling (FESC)

Conventional early exercise and mobility interventions

Study Details

Brief summary:

Critically ill patients in the intensive care unit are known to lose muscle mass and function at a rapid rate. Currently, there is a global recognition and shift in the ICU culture to reduce sedation and encourage exercise and mobilization early during the ICU stay. Functional stimulation assisted supine cycling can be applied to patients in the bed and does not require patient participation. This study seeks to evaluate the effect of conventional exercise and early mobilization in combination with functional stimulation assisted supine cycling applied early during the ICU on muscle mass, strength, and physical function, as well as patient-reported disability as compared to conventional exercise and early mobilization alone.

Conditions

ICU Acquired Weakness

Study ID

NCT03554811

Start date

Jan 1, 2020

Status verified date

Aug, 2021

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ≥ 18 years of age
  • Admitted to the ICU with a predicted ICU length of stay ≥ 4 days
  • Expected to survive the ICU stay
  • Expected to receive mechanical ventilation > 48 hours
  • Able to perform physical outcome measures pre-morbidly (with or without an assisted device)

Exclusion Criteria:

  • Proven or suspected neuromuscular weakness affecting the legs (eg- stroke or Guillain-Barré syndrome)
  • Lower limb amputation(s)
  • Assessed by medical staff as approaching imminent death or withdrawal of medical treatment within 36 hours
  • Pregnancy
  • Body mass index > 40
  • Presence of external fixator or superficial metal in lower limb
  • Open wounds or skin abrasions at electrode application points
  • Presence of pacemaker or implanted defibrillator
  • Transferred from another ICU after >48 hours of consecutive mechanical ventilation
  • Lower limb malignancy
  • Pre-existing intellectual disability or cognitive impairment limiting the ability to accurately follow instructions
  • Body habitus unable to fit the bike
  • Palliative goals of care
  • Unable to participate in FESC within 48 hours of ICU admission due to logistic reasons or due to failure in daily screening for participation

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Functional electrical stimulation assisted supine cycling

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.

active comparator: Conventional early exercise and mobility interventions

Patients will undergo standard ICU exercise and mobility interventions.

Interventions

Functional electrical stimulation assisted supine cycling (FESC)

A supine cycle ergometer attached to a six-channel stimulator will be used for FESC. Surface electrodes will be applied to the hamstrings, quadriceps, and calf muscles on both legs. Muscles will be stimulated at specific stages throughout the cycling phase. Each session will start with a 1 minute motor-driven passive cycling warm-up at a rate of 20 revolutions per minute. Patients will continue with passive, active-assisted, or active cycling, according to their level of participation. If the patients stop cycling actively, the ergometer will revert to passive cycling.

Conventional early exercise and mobility interventions

These interventions will be based on the patient's alertness and medical stability, and includes activities to maintain or increase limb range of motion and strength, in and out of bed mobility, sit to stand, and transfer training, as well as assisted ambulation.

Primary outcome measure

  • Percent change of rectus femoris cross-sectional area [ Time Frame: 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) ]

Central Contacts and Locations

Central contacts

Rachel Dirks, PhD

559-459-4029rdirks@communitymedical.org

Locations

Community Regional Medical Center

Recruiting

Fresno, California, United States, 93721

More Information

Sponsor

Fresno Community Hospital and Medical Center

Last update posted

Aug 20, 2021

Last verified

Aug, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fresno Community Hospital and Medical Center on 2021-08-20.