Sarcopenia in Older Patients in the Acute Hospital Setting

The Identification and Prevention of Sarcopenia in Older Patients in the Acute Hospital Setting

This study will assess whether the use of technology using the Virtual Gate Device (VGD) will prevent or minimize the development of hospital acquired Sarcopenia resulting from Immobilization.

Study Overview

• Status: Recruiting
• Conditions: Frailty; Sarcopenia
• Intervention / Treatment: Device: Virtual Gate Device (VGD)

Detailed Description

Modern advances in prevention, medical care, and treatments have resulted in an ever-increasing life expectancy and aging of the population. As a result, it is imperative that health care professionals and policy makers develop strategies and new technologies that enable older people to enjoy their advancing years in good health.

Sarcopenia, an age-related decrease in muscle mass, is a major factor in functional decline and frailty and leads to poor quality of life and increased health care costs in older age groups. Because sarcopenia is known to be exacerbated at the time of acute hospital admission, the development of new technologies for the prevention and diagnosis of sarcopenia will have important ramifications in promoting healthy aging in both the acute care and ambulatory settings.

A pilot interventional self-controlled study will be performed in an internal medicine department (internal medicine ward Het) at the Rambam Health Care Campus in Haifa.

Subjects will be evaluated for the risk of sarcopenia by acceptable screening instruments as well as B-mode portable ultrasound. They will then be treated using a stocking-like Virtual Gait Device (VGD) which will be applied to one randomly-assigned lower limb. The VGD is a technology that uses fussy-logic technology to stimulate calf muscles in synchrony with the patient's heartbeat, enabling a virtual gait in patients who have limited mobility.

Confidentiality will be achieved by applying a unique identifier to each trial subject in accordance with Good Clinical Practice standards.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tzvi Dwolatzky, MD; Phone Number: 972-502061183; Email: t_dwolatzky@rambam.health.gov.il
• Study Contact Backup: Name: Elad Rubin; Phone Number: 972-524685038; Email: e_rubin@rambam.health.gov.il

Study Locations

• Israel
  • North
    • Haifa, North, Israel, 3109601
      • Recruiting
      • Rambam Health Care Campus
      • Contact: Elad Rubin; Phone Number: 972-524685038; Email: e_rubin@rambam.health.gov.il
      • Contact: Tzvi Dwolatzky; Phone Number: 502061183; Email: tzvidov@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female patients 75 years of age and older.
• Patients admitted with an acute infection (clinically from a respiratory or urinary source).
• Expected length of hospitalization of at least 4 days.
• Patients who are conscious and cognitively able to provide written informed consent as determined by a score of 0 on the 4AT scale

Exclusion Criteria:

• Male and female patients under 75 years of age.
• Expected length of hospitalization of less than 4 days.
• A condition limiting the use of the virtual gate device (VGD) due to factors relating to discomfort or safety, including but not limited to: fracture, amputation, local infection, pain, paralysis of one or both lower limbs, cardiac arrhythmia or cardiac pacemaker.
• Patients who are unable to or do not provide informed consent for participation.
• A score 1 or more on the 4AT scale.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• 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: Virtual Gate Device (VGD); The Virtual Gait Device (VGD) is a technology that uses fussy-logic technology to stimulate calf muscles in synchrony with the patient's heartbeat, enabling a virtual gait in patients who have limited mobility. The stocking-like device is especially useful in older patients who are acutely hospitalized and thus at risk for sarcopenia. While physical activity and physical resistance training are well-documented as preventive measures for sarcopenia, active physical exercise is an unrealistic option for most acutely hospitalized, mobility-limited, older patients. The VGD is a practical alternative that is simple to operate. One pilot study in the orthopedics department in Hadassah Medical Center in Jerusalem, Israel was performed on patients with fractured ankles with the goal of muscle wasting prevention. The VGD will be provided by the manufacturer for use in this pilot clinical study.

Device: Virtual Gate Device (VGD); A VGD will be applied to one randomly-assigned lower limb. The VGD will be operated constantly (apart from times that the patient is being bathed or undergoing investigations or procedures) providing intermittent stimulations for a maximum of 10 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle mass	Determined by B-mode ultrasound measurement.	Day 4 of admission or last measurement prior to discharge for a maximum of 10 days.

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Tzvi Dwolatzky, MD, Rambam Health Care Campus

Publications and helpful links

General Publications

• Malmstrom TK, Miller DK, Simonsick EM, Ferrucci L, Morley JE. SARC-F: a symptom score to predict persons with sarcopenia at risk for poor functional outcomes. J Cachexia Sarcopenia Muscle. 2016 Mar;7(1):28-36. doi: 10.1002/jcsm.12048. Epub 2015 Jul 7.
• Ticinesi A, Meschi T, Narici MV, Lauretani F, Maggio M. Muscle Ultrasound and Sarcopenia in Older Individuals: A Clinical Perspective. J Am Med Dir Assoc. 2017 Apr 1;18(4):290-300. doi: 10.1016/j.jamda.2016.11.013. Epub 2017 Feb 13.
• Maddocks M, Nolan CM, Man WD, Polkey MI, Hart N, Gao W, Rafferty GF, Moxham J, Higginson IJ. Neuromuscular electrical stimulation to improve exercise capacity in patients with severe COPD: a randomised double-blind, placebo-controlled trial. Lancet Respir Med. 2016 Jan;4(1):27-36. doi: 10.1016/S2213-2600(15)00503-2. Epub 2015 Dec 15.

Helpful Links

• 4AT- Rapid clinical test for delirium

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2021
• Primary Completion (Anticipated): October 23, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 15, 2019
• First Submitted That Met QC Criteria: September 15, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 2, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Frailty; Sarcopenia
• Other Study ID Numbers: 0053-18-RMB

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: No