SarcopeniaNCT04092790
Sarcopenia in Older Patients in the Acute Hospital Setting
A study testing Virtual Gate Device (VGD) in people with Sarcopenia and Frailty, run by Rambam Health Care Campus at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Sarcopenia, Frailty
- What is being tested?
- Virtual Gate Device (VGD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Apr 2021to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, North, 3109601
Tzvi Dwolatzky, 502061183, tzvidov@gmail.com
Elad Rubin, 972-524685038, e_rubin@rambam.health.gov.il
About this study
Official title: 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.
Read the 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.
- Conditions
- Sarcopenia, Frailty
- Being tested
- Virtual Gate Device (VGD)
- Medical subject headings
- Sarcopenia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Virtual Gate Device (VGD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
Determined by B-mode ultrasound measurement.
Measured: Day 4 of admission or last measurement prior to discharge for a maximum of 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start18 Apr 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tzvi Dwolatzky, Rambam Health Care Campus
- Investigators
- Tzvi Dwolatzky, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092790
- Sponsor's protocol ID
- 0053-18-RMB
- Status last verified
- May 2024
- First submitted
- 15 Sep 2019
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27066316Ticinesi 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.
PubMed 28202349Maddocks 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.
PubMed 26701362
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Identification and Prevention of Sarcopenia in Older Patients in the Acute Hospital Setting
- ClinicalTrials.gov ID
- NCT04092790
- Acronym / sponsor ID
- 0053-18-RMB
- Conditions
- Sarcopenia, Frailty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 18 Apr 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual Gate Device (VGD) | Experimental | Device: 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. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Virtual Gate Device (VGD) |
Primary outcome
Muscle mass
Time frame: Day 4 of admission or last measurement prior to discharge for a maximum of 10 days.
Determined by B-mode ultrasound measurement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Background: PubMed 27066316Malmstrom 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.
- Background: PubMed 28202349Ticinesi 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.
- Background: PubMed 26701362Maddocks 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.
- 4AT- Rapid clinical test for deliriumLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tzvi Dwolatzky, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Gate Device (VGD) in people with Sarcopenia and Frailty, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tzvi Dwolatzky, MD (972-502061183, t_dwolatzky@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mass (time frame: Day 4 of admission or last measurement prior to discharge for a maximum of 10 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04092790, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.