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Enrollment
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Critically-ill patients who have long stays in the hospital often face prolonged periods of bed rest. It is known that these patient develop profound weakness and debilitation. The effectiveness of existing muscle activation devices that could otherwise prevent the onset of debilitation in an immobilized patient has not been demonstrated widely in this cohort. It is hypothesized that using thermal methods to augment existing muscle activation techniques may demonstrate improved performance with no corresponding change in the safety profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activation Treatment | Experimental |
| |
| Usual Care | No Intervention | This arm will not receive any study-motivated intervention. Subjects will receive usual care, but will participate in outcomes assessments. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermal-aided muscle activation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Activation Effectiveness | Research team will assess whether or not visible or palpable muscle contractions can be activated in the target patient population. | Day of ICU Discharge, expected on average 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Mass | Muscle mass will be measured at several time points during the patient stay. | At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days) |
| Muscle Strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Tidswell, MD | Baystate Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Medical Center | Tucson | Arizona | 85724 | United States | ||
| Franklin Square Medical Center |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Muscle strength will be assessed using MRC scales at various time points throughout the study
| At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days) |
| Activities of Daily Living | The subject's proficiencies and independence in Activities of Daily Living will be assessed prior to hospital discharge. | At hospital discharge (expected average 10 days) |
| Six Minute Walk | 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. | At time of first ambulation (expected average 7 days), at hospital discharge (expected average 10 days) |
| Time to ambulation | 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. | During timeframe when patient moves out of bed, expected on average 5 - 8 days into study |
| Length of stay | The subject's length of stay will be recorded from chart review. | At end of study, expected on average after 10 days |
| Ventilator Dependency | Chart review will be used to determine the number of ventilator days and the ventilator weaning time for each subject | During active ventilation and weaning period, expected to last on average 4 - 7 days per patient |
| Baltimore |
| Maryland |
| 21237 |
| United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| University of Massachusetts Medical Center | Worcester | Massachusetts | 01655 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |