ICU Acquired WeaknessNCT03554811
Early Rehabilitation Using Functional Electrical Stimulation Assisted Supine Cycling in the Intensive Care Unit
A study testing Functional electrical stimulation assisted supine cycling (FESC) and Conventional early exercise and mobility interventions in people with ICU Acquired Weakness, run by Community Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Acquired Weakness
- What is being tested?
- Functional electrical stimulation assisted supine cycling (FESC) and Conventional early exercise and mobility interventions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Community Regional Medical Center
Fresno, California, 93721
Paul Smith
About this study
Official title: 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.
- Conditions
- ICU Acquired Weakness
- Being tested
- Functional electrical stimulation assisted supine cycling (FESC), Conventional early exercise and mobility interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Conventional early exercise and mobility interventionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional early exercise and mobility interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Thickness will be measured by ultrasound at the zone of apposition during inspiration or expiration using the intercostal approach.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Through hospital discharge, an average of 15 days
ICU length of stay
The total ICU length of stay for this admission will be calculated.
Measured: Through ICU discharge, an average of 11 days
Duration of mechanical ventilation
The total length of time on mechanical ventilation
Measured: Through discontinuation of mechanical ventilation, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start1 Jan 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU Acquired WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Community Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Western University of Health Sciences
- Responsible party
- Sponsor
- Investigators
- Paul D Smith, PT, DPT, Principal investigator, Community Medical Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554811
- Sponsor's protocol ID
- 2018015
- Status last verified
- Aug 2021
- First submitted
- 20 May 2018
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03554811
- Acronym / sponsor ID
- 2018015
- Conditions
- ICU Acquired Weakness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Community Health SystemUniversity, hospital or other
- Collaborators
- Western University of Health Sciences
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional electrical stimulation assisted supine cycling | Experimental | Device: Functional electrical stimulation assisted supine cycling (FESC), Other: Conventional early exercise and mobility interventionsPatients 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. |
| Conventional early exercise and mobility interventions | Active comparator | Other: Conventional early exercise and mobility interventionsPatients will undergo standard ICU exercise and mobility interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Functional electrical stimulation assisted supine cycling |
| Conventional early exercise and mobility interventionsThese 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. | Other | Conventional early exercise and mobility interventions, Functional electrical stimulation assisted supine cycling |
Primary outcome
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)
Ultrasound measurements will be done with patients in supine position with their leg in passive extension and neutral rotation.
12 secondary outcomes
Diaphragm muscle thickness
Time frame: 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
Time frame: 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
Time frame: 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
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)
Physical function
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)
Physical function
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)
Physical function
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)
Quality of life
Time frame: At hospital discharge (an average of 15 days after admission), and 90 days, 6 months, and 1 year post ICU discharge
Cognition
Time frame: At hospital discharge (an average of 15 days after admission)
Hospital length of stay
Time frame: Through hospital discharge, an average of 15 days
ICU length of stay
Time frame: Through ICU discharge, an average of 11 days
Duration of mechanical ventilation
Time frame: Through discontinuation of mechanical ventilation, an average of 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul D Smith, PT, DPT principal investigator
Community Medical Centers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional electrical stimulation assisted supine cycling (FESC) and Conventional early exercise and mobility interventions in people with ICU Acquired Weakness, run by Community Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Dirks, PhD (559-459-4029, rdirks@communitymedical.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.