Early Rehabilitation Using Functional Electrical Stimulation Assisted Supine Cycling in the Intensive Care Unit

NCT03554811 | Unknown FDA Device

• 1 other identifier: 2018015
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percent change of rectus femoris cross-sectional area

  Ultrasound measurements will be done with patients in supine position with their leg in passive extension and neutral rotation.

  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)

Secondary Outcomes (12)

• Diaphragm muscle thickness

  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)

• Muscle strength

  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

• Muscle strength

  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

• Physical function

  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)

• Physical function

  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)

Study Arms (2)

Functional electrical stimulation assisted supine cycling

EXPERIMENTAL

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.

Device: Functional electrical stimulation assisted supine cycling (FESC); Other: Conventional early exercise and mobility interventions

Conventional early exercise and mobility interventions

ACTIVE COMPARATOR

Patients will undergo standard ICU exercise and mobility interventions.

Other: Conventional early exercise and mobility interventions

Interventions

Functional electrical stimulation assisted supine cycling (FESC) DEVICE

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.

Functional electrical stimulation assisted supine cycling

Conventional early exercise and mobility interventions OTHER

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.

Conventional early exercise and mobility interventions; Functional electrical stimulation assisted supine cycling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresno Community Hospital and Medical Center: lead
• Western University of Health Sciences: collaborator

Study Sites (1)

Community Regional Medical Center

Fresno, California, 93721, United States

RECRUITING

Study Officials

• Paul D Smith, PT, DPT

  Community Medical Centers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Dirks, PhD

CONTACT

559-459-4029; rdirks@communitymedical.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2018
• First Posted: June 13, 2018
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)