Sarcopenia in Older Patients in the Acute Hospital Setting

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04092790
• Other study ID #: 0053-18-RMB
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Rambam Health Care Campus
• Contact: Tzvi Dwolatzky, MD
• Phone: 972-502061183
• Email: t_dwolatzky[@]rambam.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frailty
• Sarcopenia

Intervention

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.

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa	North

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle mass	Determined by B-mode ultrasound measurement.	Day 4 of admission or last measurement prior to discharge for a maximum of 10 days.

External Links

•   4AT- Rapid clinical test for delirium