Sarcopenia in Older Patients in the Acute Hospital Setting

NCT04092790 | Recruiting

• 1 other identifier: 0053-18-RMB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia; Frailty

Outcome Measures

Primary Outcomes (1)

• Muscle mass

  Determined by B-mode ultrasound measurement.

  Day 4 of admission or last measurement prior to discharge for a maximum of 10 days.

Study Arms (1)

Virtual Gate Device (VGD)

EXPERIMENTAL

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)

Interventions

Virtual Gate Device (VGD) DEVICE

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.

Virtual Gate Device (VGD)

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, North, 3109601, Israel

RECRUITING

Related Publications (3)

• 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.

  PMID: 27066316 BACKGROUND

• 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.

  PMID: 28202349 BACKGROUND

• 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.

  PMID: 26701362 BACKGROUND

Related Links

• 4AT- Rapid clinical test for delirium

MeSH Terms

Conditions

Sarcopenia; Frailty

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Study Officials

• Tzvi Dwolatzky, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tzvi Dwolatzky, MD

CONTACT

972-502061183; t_dwolatzky@rambam.health.gov.il

Elad Rubin

CONTACT

972-524685038; e_rubin@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Geriatrics

Model Details: Eligible subjects will be scored either as low-risk for sarcopenia-related adverse outcomes (\<4) or high risk (≥4) via the SARC-F scoring system, and will be evaluated for sarcopenia of the lower limbs using a B-mode portable ultrasound machine used for standard clinical practice at the Rambam Health Care Campus. 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 as outlined in the investigator brochure. On day 4, ultrasound of the lower limbs will be repeated for all subjects, with repeat imaging every subsequent second day for admissions extending beyond 4 days and a maximum of 10 days after the application of the VGD. The study will include all eligible patients in the internal department (internal medicine ward Het) who agree to participate in the study and provide written informed consent.

Study Record Dates

• First Submitted: September 15, 2019
• First Posted: September 17, 2019
• Study Start: April 18, 2021
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)