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

NCT ID: NCT03554811

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2023-12-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Functional electrical stimulation assisted supine cycling (FESC)

Intervention Type: 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.

Conventional early exercise and mobility interventions

Intervention Type: 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

Patients will undergo standard ICU exercise and mobility interventions.

Group Type: ACTIVE_COMPARATOR

Conventional early exercise and mobility interventions

Intervention Type: 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.

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western University of Health Sciences

OTHER

Sponsor Role: collaborator

Fresno Community Hospital and Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul D Smith, PT, DPT

Role: PRINCIPAL_INVESTIGATOR

Community Medical Centers

Locations

Community Regional Medical Center

Fresno, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rachel Dirks, PhD

Role: CONTACT

rdirks@communitymedical.org

559-459-4029

Facility Contacts

Paul Smith

Role: primary

Other Identifiers

2018015

Identifier Type: -

Identifier Source: org_study_id