Testing of a New Therapeutic Vibration Device to Reduce Neuromuscular Weakness in Hospitalized Patients (Hospital Testing)

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.

Study Overview

• Status: Withdrawn
• Conditions: Critically Ill
• Intervention / Treatment: Diagnostic test: Therapeutic Vibration Device

Detailed Description

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, (NCT03479008) this registration represents the intervention and outcomes of testing with hospitalized patients. NCT03479008 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• sick patients admitted to the ICUs at University of Michigan hospital

Exclusion Criteria:

1. Acute Spinal Cord Injury
2. Acute vertebral body fracture or injury
3. Acute stroke or intracerebral hemorrhage
4. Hemodynamic instability or other event/condition believed by care team to warrant nonparticipation
5. Known pregnancy
6. Prisoner

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hospitalized patients; This phase will recruit hospitalized bedridden patients 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. Blood samples will also be taken to measure certain chemical markers associated with activity and increase blood flow. They may receive multiple 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2	Oxygen consumption using a VO2 monitor and mask	2 hours
EMG	Muscle contraction using noninvasive electromyography	2 hours
StO2	Tissue hemoglobin oxygen saturation (StO2) using near infrared spectroscopy of the thighs, biceps, and brain.	2 hours
Blood markers - serum glucose	Serum glucose (mg/dl)	On the day of device use (1 day)
Blood markers - lipids	lipids (mg/dl)	On the day of device use (1 day)
Blood markers - cytokines	inflammatory cytokines IL-6, TNFα, IL-1β (pg/ml)	On the day of device use (1 day)
Blood markers - growth hormone	growth hormone (ng/ml)	On the day of device use (1 day)
Blood markers - cortisol	cortisol (μg/dL)	On the day of device use (1 day)
bone turnover markers	C-terminal telopeptide of type I collagen (CTX-I) and tartrate-resistant acid phosphatase 5b (U/L)	On the day of device use (1 day)

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Benjamin S Bassin, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: HUM00129402b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No