Safety and Performance of Muscle Activation for Critical Care Patients
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|ClinicalTrials.gov Identifier: NCT01552616|
Recruitment Status : Terminated (Enrollment)
First Posted : March 13, 2012
Last Update Posted : April 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Critically-ill||Procedure: Thermal-aided muscle activation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evaluation of Thermal-aided Muscle Activation in Intensive Care Unit (ICU) Patients - A PILOT Study|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
|Experimental: Activation Treatment||
Procedure: Thermal-aided muscle activation
Thermal-aided muscle activation therapy will be provided to patients twice daily. Treatment will begin within 24 hours of admission and continue until patients are significantly ambulatory.
No Intervention: Usual Care
This arm will not receive any study-motivated intervention. Subjects will receive usual care, but will participate in outcomes assessments.
- Muscle Activation Effectiveness [ Time Frame: Day of ICU Discharge, expected on average 5 days ]Research team will assess whether or not visible or palpable muscle contractions can be activated in the target patient population.
- Muscle Mass [ Time Frame: At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days) ]Muscle mass will be measured at several time points during the patient stay.
- Muscle Strength [ Time Frame: At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days) ]Muscle strength will be assessed using MRC scales at various time points throughout the study
- Activities of Daily Living [ Time Frame: At hospital discharge (expected average 10 days) ]The subject's proficiencies and independence in Activities of Daily Living will be assessed prior to hospital discharge.
- Six Minute Walk [ Time Frame: At time of first ambulation (expected average 7 days), at hospital discharge (expected average 10 days) ]A 6 minute walk test administered per ATS guidelines will be undertaken by all patients prior to discharge. When possible at least 2 six minute walk tests will be administered.
- Time to ambulation [ Time Frame: During timeframe when patient moves out of bed, expected on average 5 - 8 days into study ]The time needed for a patient who had previously been subjected to bed rest to ambulate will be noted through chart review and nursing interviews.
- Length of stay [ Time Frame: At end of study, expected on average after 10 days ]The subject's length of stay will be recorded from chart review.
- Ventilator Dependency [ Time Frame: During active ventilation and weaning period, expected to last on average 4 - 7 days per patient ]Chart review will be used to determine the number of ventilator days and the ventilator weaning time for each subject
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552616
|United States, Arizona|
|University of Arizona Medical Center|
|Tucson, Arizona, United States, 85724|
|United States, Maryland|
|Franklin Square Medical Center|
|Baltimore, Maryland, United States, 21237|
|United States, Massachusetts|
|Baystate Medical Center|
|Springfield, Massachusetts, United States, 01199|
|University of Massachusetts Medical Center|
|Worcester, Massachusetts, United States, 01655|
|United States, Ohio|
|Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Mark Tidswell, MD||Baystate Medical Center|