Using a device to prevent muscle loss in older hospitalized patients
The Identification and Prevention of Sarcopenia in Older Patients in the Acute Hospital Setting
NA · Rambam Health Care Campus · NCT04092790
This study tests if a special device can help older patients in the hospital keep their muscles from getting weaker while they recover from infections.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Rambam Health Care Campus (other) |
| Locations | 1 site (Haifa, North) |
| Trial ID | NCT04092790 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Virtual Gate Device (VGD) in preventing or minimizing sarcopenia in older patients during hospitalization. It focuses on patients aged 75 and older who are admitted with acute infections and are expected to stay in the hospital for at least four days. Participants will be assessed for sarcopenia risk and treated with the VGD, which stimulates calf muscles to promote mobility. The study aims to address the growing concern of muscle loss in the aging population, particularly in acute care settings.
Who should consider this trial
Good fit: Ideal candidates are male and female patients aged 75 and older admitted with an acute infection and expected to stay in the hospital for at least four days.
Not a fit: Patients under 75 years of age or those with conditions that limit the use of the VGD will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and functional outcomes for older patients during and after hospitalization.
How similar studies have performed: While the use of technology for preventing sarcopenia is a growing field, this specific approach with the VGD is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Haifa, North
- Rambam Health Care Campus — Haifa, North, Israel (RECRUITING)
Study contacts
- Principal investigator: Tzvi Dwolatzky, MD — Rambam Health Care Campus
- Study coordinator: Tzvi Dwolatzky, MD
- Email: t_dwolatzky@rambam.health.gov.il
- Phone: 972-502061183
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sarcopenia, Frailty