An interventional study of Therapeutic Vibration Device in Critically Ill and Post Intensive Care Syndrome, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-30.
Sponsored by University of Michigan · Not applicable, Interventional, and Prevention
Among 22 studies in postintensive care syndrome with a site in United States — 4 open to participants now, 8 under way, 1 of them phase 3. postintensive care syndrome · United States.
Among the 22 studies in postintensive care syndrome with a site in United States, this one is the 11th largest by enrollment of the 15 interventional ones that give a count, is one of 3 that started in 2018, is one of 14 with no phase, and was the 3rd registered.
105 studies on the registry are indexed under postintensive care syndrome; 48 are open to participants now.
Browse postintensive care syndrome studies →4 of the 22 studies in postintensive care syndrome with a site in United States are open now. Recruiting first, the newest first:
Medical University of South Carolina · Sites in United States
Ages 18+
Malcom Randall VA Medical Center · Sites in United States
Ages 18–89
Vanderbilt University · Sites in United States
Ages 45+
University of Rochester · Sites in United States
Ages 7–13
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 29 postintensive care syndrome studies recruiting now, 20 (69%) set no upper age limit and 7 (24%) stop at 75 or younger; 4 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
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22 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 3 started in 2018.
This study's enrollment of 36 is below the median of 78 across 47 interventional studies indexed under postintensive care syndrome.
Median enrollment 70 across the 15 interventional studies, 66 across the 7 observational. Of the 12 that completed or were terminated, 3 (25%) have results posted.
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2 of 22 have an industry lead sponsor. The 10 most frequent:
University of Michigan is the lead sponsor of 1,507 studies on the registry; 193 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
University of Michigan has 1 study filed under postintensive care syndrome — fewer than ten, so there is no comparison to draw.
2 of the studies in postintensive care syndrome with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07906366University of RochesterBuilding Resilience Through Anxiety Virtual Education in PICU Survivors | 2027-06-01 |
| NCT03738774Vanderbilt University Medical CenterAddressing Post-Intensive Care Syndrome Among Survivors of COVID (APICS-COVID) | 2027-07 |
Add all 2 to your calendar (.ics) → With an account.
Among the 22 studies in postintensive care syndrome with a site in United States, from their registry updates:
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Objective: Test the ability of vibration to produce physiologic, biochemical, and anatomic changes consistent with exercise that would help prevent the development of muscle weakness that occurs when patients are immobile for long periods of time.
During critical illness, patients who are immobilized for more than a few days develop severe muscle and nerve weakness despite receiving full supportive care, which may include physical therapy. In patients requiring mechanical ventilation (a device that breaths for them) for longer than 7 days, the incidence of ICU-acquired weakness is reported to be between 25% and 60%. Such weakness may contribute to increased duration of mechanical ventilation, increased length of stay in the ICU and hospital, and poor quality of life among survivors. This is part of the newly recognized Post Intensive Care Syndrome (PICS). Moreover, patients who are transferred from the ICU to a high-dependency unit (HDU), intensive therapy unit (ITU), post-operative therapy or outpatient ambulatory care need to be mobile as well as awake for any physical therapy. Patients affected by sepsis (severe blood stream infections), osteoarthritis, spinal cord injury, stroke, multiple sclerosis, cerebral palsy, cancer, and other illnesses suffer muscle loss and weakness. Early mobilization (EM) has demonstrated the ability to significantly reduce the detrimental effects of prolonged immobilization such as polyneuropathy and myopathy (nerve damage and muscle weakness), which in turn reduces the time patients spend on mechanical ventilation and the overall length of hospital stay. EM treatments include intense physical therapy, cycle ergometry, transcutaneous electrical muscle stimulation (TEMS) and continuous lateral rotational therapy (CLRT). However, carrying out intense physical therapy using therapists is impractical (especially at smaller hospitals) and cannot be implemented in heavily sedated patients (patients who cannot cooperate). Evidence suggests that vibration may be capable of producing adequate muscle contraction via muscle-spinal loops that may be sufficient to reduce or prevent nerve damage and muscle weakness caused by prolonged immobilization thus serving as an effective treatment making patients stronger when they leave the ICU.
The purpose of this study is to test a prototype vibration device and strategy on its ability to exercise large muscle groups, increase muscle blood flow, and increase circulating levels of blood chemicals associated with exercise/activity. The study will be used to find optimal vibration frequencies that provide maximal evidence of associated muscle activity. Eventually the investigators hope to see a vibration device capable of delivering a more effective therapy compared to the smaller gains derived from traditional measures of physical therapy in critically ill patients such as TEMS, CLRT and cycle ergometry to patients. The vibration device may directly benefit the patient in terms of health, length of stay and reduced re-admission, hospital staff in terms of productivity (i.e., through reduction in nursing effort) and the hospital in terms of reduced cost and return on investment. Its value is also envisioned in many other populations of immobilized acutely ill and injured patients as well as those with chronic conditions.
Originally registered as a single record, this registration has been simplified to clarify the outcomes measured from the work with healthy volunteers. A new registration which will include the relevant outcomes for the trial part that will enroll hospitalized participants will be registered prior to their enrollment. The current registration will remain open until it is certain that no additional modifications of the device are required to go through a new round of iterative testing with healthy volunteers. While the total number of participants to be enrolled is larger than some early feasibility trials, the testing is done in small iterative batches to determine whether additional design changes are required. Each of these is generally less than 10 individuals.
105 studies on the registry are indexed under postintensive care syndrome; 48 are open to participants now.
This study's enrollment of 36 is below the median of 78 across 47 interventional studies indexed under postintensive care syndrome.
Browse postintensive care syndrome studies →University of Michigan is the lead sponsor of 1,507 studies on the registry; 193 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
Compared within postintensive care syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Exclusion Criteria:
This phase will recruit healthy volunteers who will be vibrated with the prototype device using various vibration frequencies to determine which frequency produces the optimal physiologic response. Physiologic responses will be determined with a number of devices capable of measuring such things as tissue oxygenation, oxygen consumption, and muscle activity. Volunteers will be randomized to receive alternating 5 minute episodes of various vibration frequencies.
Diagnostic Test: Therapeutic Vibration Device
The Therapeutic Vibration Device is capable of applying force through the axial skeletal spine, through bidirectional compression loading (or prestressing) between the shoulder and the plantar surfaces of the feet. It is placed around the body like a mobile frame so that the applied vibration can affect the whole body. The vibration actuators (drivers) are mobile and can vary in size, frequency response, and force. The design minimizes the possibility of mechanical interference for ventilated/intubated patients.
Change in Regional Hemoglobin Oxygen Saturation
Change in tissue regional hemoglobin oxygen saturation (rSO2) using near infrared spectroscopy of the thighs,calf, and biceps Baseline measurements were taken for 1 minute and vibration period was for 10 minutes. The mean value of rSO2 for 1 minute preceding vibration was computed as the baseline value. For the data collected during vibration, a moving average peak analysis for every 1 minute for 10 minutes of rSO2 data was carried out. The maximum value of the moving average was selected as the mean value of vibration. The moving average peak analysis was independently conducted for all three measurements from GL, RF and BB.
Time frame: 10 minutes
VO2 and VCO2
Oxygen consumption using a VO2 monitor and mask For the baseline data, a mean of 3 minutes of the segment preceding vibration was computed. For the data collected during vibration, a moving average peak analysis for every 3 minutes for 10 minutes of VO2, VCO2 data was carried out. The maximum value of the moving average was selected as the mean value. This methodology of segment extraction precluded the possibility of picking up short transient changes in metabolic data and helped ensure selection of steady set of values of metabolic variables which estimated the true response of the participant.
Time frame: baseline and during device use (10 minutes)
Energy Expenditure
For the baseline data, a mean of 3 minutes of the segment preceding vibration was computed. For the data collected during vibration, a moving average peak analysis for every 3 minutes for 10 minutes of EE data was carried out. The maximum value of the moving average was selected as the mean value. This methodology of segment extraction precluded the possibility of picking up short transient changes in metabolic data and helped ensure selection of steady set of values of metabolic variables which estimated the true response of the participant.
Time frame: 10 minutes
Minute Variation
For the baseline data, a mean of 3 minutes of the segment preceding vibration was computed. For the data collected during vibration, a moving average peak analysis for every 3 minutes for 10 minutes of data was carried out. The maximum value of the moving average was selected as the mean value. This methodology of segment extraction precluded the possibility of picking up short transient changes in metabolic data and helped ensure selection of steady set of values of metabolic variables which estimated the true response of the participant.
Time frame: 10 minutes
Tidal Volume
For the baseline data, a mean of 3 minutes of the segment preceding vibration was computed. For the data collected during vibration, a moving average peak analysis for every 3 minutes for 10 minutes of data was carried out. The maximum value of the moving average was selected as the mean value. This methodology of segment extraction precluded the possibility of picking up short transient changes in metabolic data and helped ensure selection of steady set of values of metabolic variables which estimated the true response of the participant.
Time frame: 10 minutes
EMG
Simultaneous multi-frequency synchronous excitation was the stimulus, using 15 Hz at shoulders and 25 Hz at feet. Baseline EMG data were recorded prior to commencement of vibration; a 1 second segment was extracted for post processing. For computing muscle activation during vibration, a 10 second EMG segment was extracted after 1 minute of start of the vibration. Extracted signals were filtered to remove artifacts; similar filtering procedures were carried out for EMG signals recorded during MVIC tests and baseline recording. The root-mean square values of EMG signals of vibration and MVIC were calculated. Normalization to MVIC followed (Vibration EMGRMS)/(MVIC EMGRMS) × 100. Bias calculated using (Filtered EMGRMS @ baseline)/(Unfiltered EMGRMS @ baseline); bias-corrected EMG during vibration computed using (Vibration EMGRMS /Bias). Therefore each muscle site has only 1 reported value, representative of the combined effect of multi-frequency excitation provided at shoulders and feet.
Time frame: baseline and during intervention (not exceeding 1 minute)
Prior to actual testing for the outcomes listed in this registration, 8 participants were recruited and consented for tuning and characterizing the device prior to structured testing.
| Milestone | Healthy Volunteers (Iterative Device Development) |
|---|---|
| Started | 22 |
| Completed | 19 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 3 |
Change in tissue regional hemoglobin oxygen saturation (rSO2) using near infrared spectroscopy of the thighs,calf, and biceps Baseline measurements were taken for 1 minute and vibration period was for 10 minutes. The mean value of rSO2 for 1 minute preceding vibration was computed as the baseline value. For the data collected during vibration, a moving average peak analysis for every 1 minute for 10 minutes of rSO2 data was carried out. The maximum value of the moving average was selected as the mean value of vibration. The moving average peak analysis was independently conducted for all three measurements from GL, RF and BB.
| percent of oxygenation | Healthy Volunteers (1st Iteration of Device Development) |
|---|---|
| Thighs (baseline) | 75.65 ± 0.98 |
| Thighs (during stimulation | 77.01 ± 1.09 |
| Calf muscle (baseline) | 73.83 ± 0.93 |
| Calf (during stimulation) | 77.09 ± 1.13 |
| Biceps (baseline) | 72.23 ± 1.27 |
| Biceps (during stimulation) | 74.15 ± 1.40 |
Oxygen consumption using a VO2 monitor and mask For the baseline data, a mean of 3 minutes of the segment preceding vibration was computed. For the data collected during vibration, a moving average peak analysis for every 3 minutes for 10 minutes of VO2, VCO2 data was carried out. The maximum value of the moving average was selected as the mean value. This methodology of segment extraction precluded the possibility of picking up short transient changes in metabolic data and helped ensure selection of steady set of values of metabolic variables which estimated the true response of the participant.
| ml/(kg*min) | Healthy Volunteers (1st Iteration of Device Development) |
|---|---|
| VO2 (baseline) | 3.19 ± 0.16 |
| VO2 (during stimulation) | 3.84 ± .22 |
| VCO2 (baseline) | 2.54 ± .14 |
| VCO2 (during stimulation) | 3.07 ± 0.18 |
For the baseline data, a mean of 3 minutes of the segment preceding vibration was computed. For the data collected during vibration, a moving average peak analysis for every 3 minutes for 10 minutes of EE data was carried out. The maximum value of the moving average was selected as the mean value. This methodology of segment extraction precluded the possibility of picking up short transient changes in metabolic data and helped ensure selection of steady set of values of metabolic variables which estimated the true response of the participant.
| kcal/minute | Healthy Volunteers (1st Iteration of Device Development) |
|---|---|
| Baseline | 1.12 ± 0.07 |
| Vibration | 1.35 ± 0.09 |
For the baseline data, a mean of 3 minutes of the segment preceding vibration was computed. For the data collected during vibration, a moving average peak analysis for every 3 minutes for 10 minutes of data was carried out. The maximum value of the moving average was selected as the mean value. This methodology of segment extraction precluded the possibility of picking up short transient changes in metabolic data and helped ensure selection of steady set of values of metabolic variables which estimated the true response of the participant.
| liters/minute | Healthy Volunteers (1st Iteration of Device Development) |
|---|---|
| Baseline | 7.09 ± 0.40 |
| Vibration | 8.50 ± 0.55 |
For the baseline data, a mean of 3 minutes of the segment preceding vibration was computed. For the data collected during vibration, a moving average peak analysis for every 3 minutes for 10 minutes of data was carried out. The maximum value of the moving average was selected as the mean value. This methodology of segment extraction precluded the possibility of picking up short transient changes in metabolic data and helped ensure selection of steady set of values of metabolic variables which estimated the true response of the participant.
| liters | Healthy Volunteers (1st Iteration of Device Development) |
|---|---|
| Baseline | 0.55 ± 0.04 |
| Vibration | 0.68 ± 0.09 |
Simultaneous multi-frequency synchronous excitation was the stimulus, using 15 Hz at shoulders and 25 Hz at feet. Baseline EMG data were recorded prior to commencement of vibration; a 1 second segment was extracted for post processing. For computing muscle activation during vibration, a 10 second EMG segment was extracted after 1 minute of start of the vibration. Extracted signals were filtered to remove artifacts; similar filtering procedures were carried out for EMG signals recorded during MVIC tests and baseline recording. The root-mean square values of EMG signals of vibration and MVIC were calculated. Normalization to MVIC followed (Vibration EMGRMS)/(MVIC EMGRMS) × 100. Bias calculated using (Filtered EMGRMS @ baseline)/(Unfiltered EMGRMS @ baseline); bias-corrected EMG during vibration computed using (Vibration EMGRMS /Bias). Therefore each muscle site has only 1 reported value, representative of the combined effect of multi-frequency excitation provided at shoulders and feet.
| percentage of MVC | Healthy Volunteers (1st Iteration of Device Development) |
|---|---|
| Baseline bellies of soleus (SO) | 13.10 ± 1.72 |
| During vibration bellies of soleus (SO) | 62.67 ± 17.42 |
| Baseline tibialis anterior (TA) | 5.15 ± 0.75 |
| During vibration tibialis anterior (TA) | 11.59 ± 2.36 |
| Baseline gastroenemius lateralis (GL) | 3.17 ± 0.24 |
| During vibration gastroenemius lateralis (GL) | 7.14 ± 1.16 |
| Baseline vastus medialis (VM) | 5.41 ± 0.64 |
| During vibration vastus medialis (VM) | 8.52 ± 1.25 |
| Baseline vastus lateralis (VL) | 4.33 ± 0.52 |
| During vibration vastus lateralis (VL) | 6.57 ± 0.73 |
| Baselin rectus femoris (RF) | 4.82 ± 1.56 |
| During vibration rectus femoris (RF) | 5.58 ± 0.51 |
| Baseline semitendinosus (ST) | 6.31 ± 1.97 |
| During vibration semitendinosus (ST) | 6.64 ± 0.95 |
| Baseline deltoideus medius | 1.23 ± 0.13 |
| During vibration deltoideus medius | 4.25 ± 1.05 |
Collected over AEs were collected only on the days of testing for occurrences during testing sessions. Testing sessions lasted 2-3 hours and the maximum time between first and last session was 146 days, though a more typical spread was 35 days. (Sessions were held at the participant's convenience.). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Volunteers (1st Iteration of Device Development) | 0/22 (0%) | 0/22 (0%) | 3/22 (13.6%) |
| Event | Healthy Volunteers (1st Iteration of Device Development) |
|---|---|
| DiscomfortGeneral disorders | 3/22 |
| Age, Continuous(years) | Healthy Volunteers (Iterative Device Development) |
|---|---|
| Mean | 51.7 ± 19.5 |
| Sex: Female, Male(Participants) | Healthy Volunteers (Iterative Device Development) |
|---|---|
| Female | 9 |
| Male | 10 |
| Race and Ethnicity Not Collected(Participants) | Healthy Volunteers (Iterative Device Development) |
|---|
| Region of Enrollment(Participants) | Healthy Volunteers (Iterative Device Development) |
|---|---|
| United States | 19 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Mar 2019, 11 months.
Results were first posted in May 2024, 5 years 2 months after primary completion.
Of 39 interventional studies with no phase under postintensive care syndrome, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 38. This study's 11 months is below that.
How these figures are worked out, and which studies are left out of them.
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