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

Early Rehabilitation Using Functional Electrical Stimulation Assisted Supine Cycling Effect on Muscle Mass, Strength, Biomarkers, and Functional Outcomes as Compared With Conventional Exercise and Early Mobilization Alone in Critically Ill Patients in the Intensive Care Unit

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.

Study Overview

• Status: Recruiting
• Conditions: ICU Acquired Weakness
• Intervention / Treatment: Device: Functional electrical stimulation assisted supine cycling (FESC); Other: Conventional early exercise and mobility interventions

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel Dirks, PhD; Phone Number: 559-459-4029; Email: rdirks@communitymedical.org

Study Locations

• United States
  • California
    • Fresno, California, United States, 93721
      • Recruiting
      • Community Regional Medical Center
      • Contact: Paul Smith

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.; Other: 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.
Active Comparator: Conventional early exercise and mobility interventions; Patients will undergo standard ICU exercise and mobility interventions.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diaphragm muscle thickness	Thickness will be measured by ultrasound at the zone of apposition during inspiration or expiration using the intercostal approach.	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	Muscle strength will be assessed using the Medical Research Council Scale. This muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle. Weaker muscles will range from 0-3 and stronger muscles will receive grades 4 or 5.	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	Muscle strength will be assessed using hand-held dynamometry	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	Physical function will be assessed using the physical function in ICU (PFIT) test	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	Physical function will be assessed using the functional status score in the ICU (FSS-ICU). This score consists of 3 pre-ambulation categories (rolling; supine to sit transfer; and unsupported sitting) and 2 ambulation categories (sit to stand transfers; ambulation). Each category is scored from 1 (total dependent assistance) to 7 (complete independence) with a total score range of 0-35 (0: unable to perform a task due to physical limitations or medical status).	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	Physical function will be assessed using the short physical performance battery (SPPB)	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	Physical function will be assessed using the six-minute walk test (6MWT)	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)
Quality of life	Quality of life will be measured using the 36-item Short Health Survey (SF-36), which assess eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each item is scored on a 0-100 scale and items in the same category are averaged together to create the 8 scale scores, with 0 being the lowest score and 100 being the highest for each category.	At hospital discharge (an average of 15 days after admission), and 90 days, 6 months, and 1 year post ICU discharge
Cognition	Cognition will be assessed using the Montreal Cognitive Assessment (MoCA).	At hospital discharge (an average of 15 days after admission)
Hospital length of stay	The total hospital length of stay for this admission will be calculated.	Through hospital discharge, an average of 15 days
ICU length of stay	The total ICU length of stay for this admission will be calculated.	Through ICU discharge, an average of 11 days
Duration of mechanical ventilation	The total length of time on mechanical ventilation	Through discontinuation of mechanical ventilation, an average of 10 days

Collaborators and Investigators

• Sponsor: Fresno Community Hospital and Medical Center
• Collaborators: Western University of Health Sciences
• Investigators: Principal Investigator: Paul D Smith, PT, DPT, Community Medical Centers

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 20, 2018
• First Submitted That Met QC Criteria: May 31, 2018
• First Posted (Actual): June 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2018015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes