SarcopeniaMQSNCT03196960
Effects of Mobility Dose in Surgical Intensive Care Unit Patients
An observational study of Sarcopenia and Muscle Weakness, run by Massachusetts General Hospital at 3 sites in 3 countries.
Trial summary
The primary aim of this study is to assess if the mobility dose that patients receive in the surgical intensive care unit (SICU) predicts adverse discharge disposition (primary endpoint), and muscle wasting diagnosed by bedside ultrasound (secondary endpoint). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Muscle Weakness, Critical Illness
- How many people
- 150 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 22 May 2017to Dec 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients recovering in an intensive care unit following a trauma or a surgical procedure
Who may be able to join
- Adults (18 years of age or greater)
- Barthel score ≥70 from a proxy describing patient function 2 weeks before admission
- Expected stay on the ICU of >=3 days
Who cannot join
- Patients transferred from other hospitals, long-term rehabilitation facilities or nursing homes with a preceding stay of more than 48 hours
- Hospitalization 1 month prior to ICU admission >7 days
- Discussion about changing the goals of care from cure to comfort
- High risk of persistent brain injury (GCS<5 motor component and presence of TBI)
- Patients with neurodegenerative diseases
- Subjects with absence of a lower extremity
- Patients with paraplegia or tetraplegia
- Pregnancy
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Matthias Eikermann, MD PhD
Germany1 site, 1 recruiting
- Recruiting
Klinikum Rechts der Isar
Munich, Bavaria, 81675
Stefan Schaller, MD
Italy1 site, 1 recruiting
- Recruiting
Università degli Studi di Brescia
Brescia, Lombardy, 25123
Nicola Latronico, MD
About this study
Official title: Effects of Mobility Dose in Surgical Intensive Care Unit Patients on Adverse Discharge Disposition
The primary aim of this study is to assess if the mobility dose that patients receive in the surgical intensive care unit (SICU) predicts adverse discharge disposition (primary endpoint), and muscle wasting diagnosed by bedside ultrasound (secondary endpoint).
Read the detailed description
Our research group aims to better understand how patients on the SICU are mobilized and the impact it has on adverse discharge disposition and functional outcome after hospital discharge.
We have previously developed and validated the Surgical Intensive Care Unit Optimal Mobilization Score (SOMS), an algorithm to guide and facilitate early mobilization to advance mobility of SICU patients (NCT01363102). In addition, we have established the use of bedside ultrasound technology to quantify cross sectional area of the rectus femoris muscle, which allows an objective, user-independent quantification of muscle wasting (NCT02270502).
In this study we measure the dose of mobility, defined as a function of both the mobility provided by nursing and physical therapists (e.g., sitting at the edge of the bed, ambulating) as well as its duration. We will build on an existing mobility intensity quantification tool (NCT01674608) and add a domain that quantifies its duration in order to obtain a broad picture of the mobilization of patients on the SICU. The mobility dose is expressed by the mobility quantification score that has been developed by our team. We will then test the hypotheses that mobilization dose in the ICU predicts discharge disposition, defined as discharge to facilities providing long-term care assistance for daily activities, including nursing homes and skilled nursing facilities, hospice at the patient's home, hospice in a health care facility; or in-hospital mortality. Further we will evaluate the association between mobility dose and cross sectional area of the rectus femoris muscle measured by bedside ultrasound as a potential reflection of ICU-acquired muscle weakness (exploratory outcome).
Mobilization Quantification score: MQS (Detailed table linked in reference section)
This score integrates the highest rated activities within each mobility session - from physical therapy and nursing. By multiplying the scale it gets greater and allows a better interpretation of mobility intensity. It adds value of mobility dose across sessions considering the entire spectrum of active participation of the patient over the day.
Some specifics:
- If patient achieves a level in between predefined MQS levels we score the closest lower level
- We collect mobility data for the night time by interviewing the day nurses and asking them about the patients' mobilization also during night time
- We round up the duration of each mobility session: Passive range of motion (PRM) conducted 4 times during the day counts as: 1*4=4 (corresponding to 4 units/hours)
- For each session, we calculate the highest mobility level for the duration of the mobility session: e.g. Patient is standing for 5 minutes before s/he walks with 2 assists for 10 minutes: 3*7=21 (adding up the duration of various activities within a session and multiplying it by the highest achieved mobility level). Sitting passively in the chair is an exception (see below).
Sitting:
- Sitting in the chair counts as a separate session. Per sitting session a maximum of 2 hours are counted. For example: if a patient was sitting for a duration of either 2, 4 or 5 hours, we would always count: 2*4=8
- For patients stepping/shuffling/walking to the chair we use level 5 every time the patient is doing it. E.g. patient is shuffling to the chair, sitting for 2 hours and then walking back: 5*1+2*4+5*1 =28
- Distinct sitting sessions are defined by the patient being back in bed in between the sessions of sitting in the chair. E.g. the patient gets actively to chair by stand-step/shuffle, sits in chair for 6 hours, during sitting session patient gets up twice and afterwards gets back to bed by stand-step/shuffle:
5*1(to chair)+2*4(sitting)+5*1(back to bed)+5*2(standing up 2x in between)=28
- Conditions
- Sarcopenia, Muscle Weakness, Critical Illness
- Keywords
- Mobilization Therapy, Critical Illness, Muscle Strength, Functional Mobility, Outcome, Intensive Care Unit, Quality of Life
- Medical subject headings
- Sarcopenia, Muscle Weakness, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Hospital Discharge Disposition
Adverse hospital discharge is defined as discharge to facilities providing long-term care assistance for daily activities, including nursing homes and skilled nursing facilities, hospice at the patient's home, hospice in a health care facility, or in-hospital mortality.
Measured: Patient will be followed until hospital discharge, an expected 3 to 30 days
Secondary outcomes (15)
Rectus Femoris Muscle Cross Sectional Area
Rectus femoris cross sectional area will be measured by bedside ultrasound
Measured: Rectus femoris cross sectional area will be measured twice, at enrollment and day of ICU discharge, an expected 3 to 30 days.
Mobility Dose as measured by the Mobilization Quantification Score (MQS)
Mobilization Quantification Score (MQS) is a composition of the validated ICU mobility score, a 0 to 10 value scale that measures the mobility milestones in critically ill patients, multiplied by a for each level previously defined time unit (5 or 30 minutes correspond to one unit).
Measured: Patients will be followed until SICU discharge, an expected 3 to 30 days.
Abbreviated Functional independence measure (FIM) score at Surgical Intensive Care Unit (SICU) discharge and hospital discharge
Abbreviated FIM score obtained by physical therapy (PT) within 48 hours of discharge, and by research assistant on the day of discharge if the subject was not seen by PT in the indicated time period.
Measured: Patients will be followed until hospital discharge an expected 3 to 40 days.
SICU length of stay
Number of days from SICU admission to SICU discharge
Measured: Patients will be followed until SICU discharge, an expected 3 to 30 days.
Hospital length of stay
Number of days from hospital admission to hospital discharge
Measured: Patients will be followed until hospital discharge an expected 3 to 40 days.
SICU Ventilator-free days
Number of days spent on the SICU that patient is not receiving mechanical ventilation.
Measured: Patients will be followed until ICU discharge, an expected 3 to 30 days.
SICU Vasopressor-free days
Number of days spent on the SICU that patient is not receiving any vasopressor medications.
Measured: Patients will be followed until ICU discharge, an expected 3 to 30 days.
SICU Delirium-free days
Days spent on the SICU that patient is Confusion assessment method (CAM)-ICU/Richmond Agitation-Sedation Scale (RASS) negative.
Measured: Patients will be followed until ICU discharge, an expected 3 to 30 days.
SICU Neuromuscular Blocking drug-free days
Number of days spent on the ICU that patient is not receiving Neuromuscular Blocking Agents
Measured: Patients will be followed until ICU discharge, an expected 3 to 30 days.
Opioid Use
Opioid dose administered, calculated as morphine equivalent dose.
Measured: Patients will be followed until ICU discharge, an expected 3 to 30 days.
Corticosteroid Days
Number of day on ICU with corticosteroid administration Number of day on ICU with corticosteroid administration Number of ICU days with corticosteroid administration
Measured: Patients will be followed until ICU discharge, an expected 3 to 30 days.
Physical Work Capacity
Obtained after hospital discharge, measured by the Duke Activity Status Index (DASI)
Measured: Measured three months after hospital discharge
3-Month Mortality
Measured: Evaluated three months after hospital discharge
Falls
Number of Falls during ICU stay
Measured: Patients will be followed until ICU discharge, an expected 3 to 30 days.
Side effects of mobilization therapy
Number of unfavorable signs and symptoms or unintended deterioration of clinical status associated with mobilization therapy, including, but not limited to, unplanned extubation or dislodgment of drains, arterial catheters, venous devices, or other medical equipment. The relationship of any untoward event to mobilization therapy was assessed by the clinician and reported as unrelated, unlikely, possibly, or definitely related. Adverse events (AE) were also categorized by intensity as mild, moderate, or severe
Measured: Patients will be followed until ICU discharge, an expected 3 to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start22 May 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich, Università degli Studi di Brescia
- Responsible party
- Principal investigator, Matthias Eikermann, MD PhD, Massachusetts General Hospital
- Investigators
- Matthias Eikermann, MD PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196960
- Sponsor's protocol ID
- 2016P002045
- Acronym
- MQS
- Status last verified
- Sep 2018
- First submitted
- 21 Jun 2017
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mueller N, Murthy S, Tainter CR, Lee J, Riddell K, Fintelmann FJ, Grabitz SD, Timm FP, Levi B, Kurth T, Eikermann M. Can Sarcopenia Quantified by Ultrasound of the Rectus Femoris Muscle Predict Adverse Outcome of Surgical Intensive Care Unit Patients as well as Frailty? A Prospective, Observational Cohort Study. Ann Surg. 2016 Dec;264(6):1116-1124. doi: 10.1097/SLA.0000000000001546.
PubMed 26655919Schaller SJ, Anstey M, Blobner M, Edrich T, Grabitz SD, Gradwohl-Matis I, Heim M, Houle T, Kurth T, Latronico N, Lee J, Meyer MJ, Peponis T, Talmor D, Velmahos GC, Waak K, Walz JM, Zafonte R, Eikermann M; International Early SOMS-guided Mobilization Research Initiative. Early, goal-directed mobilisation in the surgical intensive care unit: a randomised controlled trial. Lancet. 2016 Oct 1;388(10052):1377-1388. doi: 10.1016/S0140-6736(16)31637-3.
PubMed 27707496Lee JJ, Waak K, Grosse-Sundrup M, Xue F, Lee J, Chipman D, Ryan C, Bittner EA, Schmidt U, Eikermann M. Global muscle strength but not grip strength predicts mortality and length of stay in a general population in a surgical intensive care unit. Phys Ther. 2012 Dec;92(12):1546-55. doi: 10.2522/ptj.20110403. Epub 2012 Sep 13.
PubMed 22976446Hlatky MA, Boineau RE, Higginbotham MB, Lee KL, Mark DB, Califf RM, Cobb FR, Pryor DB. A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol. 1989 Sep 15;64(10):651-4. doi: 10.1016/0002-9149(89)90496-7.
PubMed 2782256Kasotakis G, Schmidt U, Perry D, Grosse-Sundrup M, Benjamin J, Ryan C, Tully S, Hirschberg R, Waak K, Velmahos G, Bittner EA, Zafonte R, Cobb JP, Eikermann M. The surgical intensive care unit optimal mobility score predicts mortality and length of stay. Crit Care Med. 2012 Apr;40(4):1122-8. doi: 10.1097/CCM.0b013e3182376e6d.
PubMed 22067629Tipping CJ, Bailey MJ, Bellomo R, Berney S, Buhr H, Denehy L, Harrold M, Holland A, Higgins AM, Iwashyna TJ, Needham D, Presneill J, Saxena M, Skinner EH, Webb S, Young P, Zanni J, Hodgson CL. The ICU Mobility Scale Has Construct and Predictive Validity and Is Responsive. A Multicenter Observational Study. Ann Am Thorac Soc. 2016 Jun;13(6):887-93. doi: 10.1513/AnnalsATS.201510-717OC.
PubMed 27015233Scheffenbichler FT, Teja B, Wongtangman K, Mazwi N, Waak K, Schaller SJ, Xu X, Barbieri S, Fagoni N, Cassavaugh J, Blobner M, Hodgson CL, Latronico N, Eikermann M. Effects of the Level and Duration of Mobilization Therapy in the Surgical ICU on the Loss of the Ability to Live Independently: An International Prospective Cohort Study. Crit Care Med. 2021 Mar 1;49(3):e247-e257. doi: 10.1097/CCM.0000000000004808.
PubMed 33416257
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mobility Dose in Surgical Intensive Care Unit Patients on Adverse Discharge Disposition
- ClinicalTrials.gov ID
- NCT03196960
- Acronym / sponsor ID
- MQS / 2016P002045
- Conditions
- Sarcopenia, Muscle Weakness, Critical Illness
- Keywords
- Mobilization Therapy, Critical Illness, Muscle Strength, Functional Mobility, Outcome, Intensive Care Unit, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Technical University of Munich, Università degli Studi di Brescia
- Study start
- 22 May 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 23 Jun 2017 (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.
The primary aim of this study is to assess if the mobility dose that patients receive in the surgical intensive care unit (SICU) predicts adverse discharge disposition (primary endpoint), and muscle wasting diagnosed by bedside ultrasound (secondary endpoint).
Detailed description
Our research group aims to better understand how patients on the SICU are mobilized and the impact it has on adverse discharge disposition and functional outcome after hospital discharge.
We have previously developed and validated the Surgical Intensive Care Unit Optimal Mobilization Score (SOMS), an algorithm to guide and facilitate early mobilization to advance mobility of SICU patients (NCT01363102). In addition, we have established the use of bedside ultrasound technology to quantify cross sectional area of the rectus femoris muscle, which allows an objective, user-independent quantification of muscle wasting (NCT02270502).
In this study we measure the dose of mobility, defined as a function of both the mobility provided by nursing and physical therapists (e.g., sitting at the edge of the bed, ambulating) as well as its duration. We will build on an existing mobility intensity quantification tool (NCT01674608) and add a domain that quantifies its duration in order to obtain a broad picture of the mobilization of patients on the SICU. The mobility dose is expressed by the mobility quantification score that has been developed by our team. We will then test the hypotheses that mobilization dose in the ICU predicts discharge disposition, defined as discharge to facilities providing long-term care assistance for daily activities, including nursing homes and skilled nursing facilities, hospice at the patient's home, hospice in a health care facility; or in-hospital mortality. Further we will evaluate the association between mobility dose and cross sectional area of the rectus femoris muscle measured by bedside ultrasound as a potential reflection of ICU-acquired muscle weakness (exploratory outcome).
Mobilization Quantification score: MQS (Detailed table linked in reference section)
This score integrates the highest rated activities within each mobility session - from physical therapy and nursing. By multiplying the scale it gets greater and allows a better interpretation of mobility intensity. It adds value of mobility dose across sessions considering the entire spectrum of active participation of the patient over the day.
Some specifics:
- If patient achieves a level in between predefined MQS levels we score the closest lower level
- We collect mobility data for the night time by interviewing the day nurses and asking them about the patients' mobilization also during night time
- We round up the duration of each mobility session: Passive range of motion (PRM) conducted 4 times during the day counts as: 1*4=4 (corresponding to 4 units/hours)
- For each session, we calculate the highest mobility level for the duration of the mobility session: e.g. Patient is standing for 5 minutes before s/he walks with 2 assists for 10 minutes: 3*7=21 (adding up the duration of various activities within a session and multiplying it by the highest achieved mobility level). Sitting passively in the chair is an exception (see below).
Sitting:
- Sitting in the chair counts as a separate session. Per sitting session a maximum of 2 hours are counted. For example: if a patient was sitting for a duration of either 2, 4 or 5 hours, we would always count: 2*4=8
- For patients stepping/shuffling/walking to the chair we use level 5 every time the patient is doing it. E.g. patient is shuffling to the chair, sitting for 2 hours and then walking back: 5*1+2*4+5*1 =28
- Distinct sitting sessions are defined by the patient being back in bed in between the sessions of sitting in the chair. E.g. the patient gets actively to chair by stand-step/shuffle, sits in chair for 6 hours, during sitting session patient gets up twice and afterwards gets back to bed by stand-step/shuffle:
5*1(to chair)+2*4(sitting)+5*1(back to bed)+5*2(standing up 2x in between)=28
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients recovering in an intensive care unit following a trauma or a surgical procedure
Key inclusion criteria (3 listed)
- Adults (18 years of age or greater)
- Barthel score ≥70 from a proxy describing patient function 2 weeks before admission
- Expected stay on the ICU of >=3 days
Key exclusion criteria (8 listed)
- Patients transferred from other hospitals, long-term rehabilitation facilities or nursing homes with a preceding stay of more than 48 hours
- Hospitalization 1 month prior to ICU admission >7 days
- Discussion about changing the goals of care from cure to comfort
- High risk of persistent brain injury (GCS<5 motor component and presence of TBI)
- Patients with neurodegenerative diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adverse Hospital Discharge Disposition
Time frame: Patient will be followed until hospital discharge, an expected 3 to 30 days
Adverse hospital discharge is defined as discharge to facilities providing long-term care assistance for daily activities, including nursing homes and skilled nursing facilities, hospice at the patient's home, hospice in a health care facility, or in-hospital mortality.
15 secondary outcomes
Rectus Femoris Muscle Cross Sectional Area
Time frame: Rectus femoris cross sectional area will be measured twice, at enrollment and day of ICU discharge, an expected 3 to 30 days.
Mobility Dose as measured by the Mobilization Quantification Score (MQS)
Time frame: Patients will be followed until SICU discharge, an expected 3 to 30 days.
Abbreviated Functional independence measure (FIM) score at Surgical Intensive Care Unit (SICU) discharge and hospital discharge
Time frame: Patients will be followed until hospital discharge an expected 3 to 40 days.
SICU length of stay
Time frame: Patients will be followed until SICU discharge, an expected 3 to 30 days.
Hospital length of stay
Time frame: Patients will be followed until hospital discharge an expected 3 to 40 days.
SICU Ventilator-free days
Time frame: Patients will be followed until ICU discharge, an expected 3 to 30 days.
SICU Vasopressor-free days
Time frame: Patients will be followed until ICU discharge, an expected 3 to 30 days.
SICU Delirium-free days
Time frame: Patients will be followed until ICU discharge, an expected 3 to 30 days.
SICU Neuromuscular Blocking drug-free days
Time frame: Patients will be followed until ICU discharge, an expected 3 to 30 days.
Opioid Use
Time frame: Patients will be followed until ICU discharge, an expected 3 to 30 days.
Corticosteroid Days
Time frame: Patients will be followed until ICU discharge, an expected 3 to 30 days.
Physical Work Capacity
Time frame: Measured three months after hospital discharge
3-Month Mortality
Time frame: Evaluated three months after hospital discharge
Falls
Time frame: Patients will be followed until ICU discharge, an expected 3 to 30 days.
Side effects of mobilization therapy
Time frame: Patients will be followed until ICU discharge, an expected 3 to 30 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Background: PubMed 26655919Mueller N, Murthy S, Tainter CR, Lee J, Riddell K, Fintelmann FJ, Grabitz SD, Timm FP, Levi B, Kurth T, Eikermann M. Can Sarcopenia Quantified by Ultrasound of the Rectus Femoris Muscle Predict Adverse Outcome of Surgical Intensive Care Unit Patients as well as Frailty? A Prospective, Observational Cohort Study. Ann Surg. 2016 Dec;264(6):1116-1124. doi: 10.1097/SLA.0000000000001546.
- Background: PubMed 27707496Schaller SJ, Anstey M, Blobner M, Edrich T, Grabitz SD, Gradwohl-Matis I, Heim M, Houle T, Kurth T, Latronico N, Lee J, Meyer MJ, Peponis T, Talmor D, Velmahos GC, Waak K, Walz JM, Zafonte R, Eikermann M; International Early SOMS-guided Mobilization Research Initiative. Early, goal-directed mobilisation in the surgical intensive care unit: a randomised controlled trial. Lancet. 2016 Oct 1;388(10052):1377-1388. doi: 10.1016/S0140-6736(16)31637-3.
- Background: PubMed 22976446Lee JJ, Waak K, Grosse-Sundrup M, Xue F, Lee J, Chipman D, Ryan C, Bittner EA, Schmidt U, Eikermann M. Global muscle strength but not grip strength predicts mortality and length of stay in a general population in a surgical intensive care unit. Phys Ther. 2012 Dec;92(12):1546-55. doi: 10.2522/ptj.20110403. Epub 2012 Sep 13.
- Background: PubMed 2782256Hlatky MA, Boineau RE, Higginbotham MB, Lee KL, Mark DB, Califf RM, Cobb FR, Pryor DB. A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol. 1989 Sep 15;64(10):651-4. doi: 10.1016/0002-9149(89)90496-7.
- Background: PubMed 22067629Kasotakis G, Schmidt U, Perry D, Grosse-Sundrup M, Benjamin J, Ryan C, Tully S, Hirschberg R, Waak K, Velmahos G, Bittner EA, Zafonte R, Cobb JP, Eikermann M. The surgical intensive care unit optimal mobility score predicts mortality and length of stay. Crit Care Med. 2012 Apr;40(4):1122-8. doi: 10.1097/CCM.0b013e3182376e6d.
- Background: PubMed 27015233Tipping CJ, Bailey MJ, Bellomo R, Berney S, Buhr H, Denehy L, Harrold M, Holland A, Higgins AM, Iwashyna TJ, Needham D, Presneill J, Saxena M, Skinner EH, Webb S, Young P, Zanni J, Hodgson CL. The ICU Mobility Scale Has Construct and Predictive Validity and Is Responsive. A Multicenter Observational Study. Ann Am Thorac Soc. 2016 Jun;13(6):887-93. doi: 10.1513/AnnalsATS.201510-717OC.
- Derived from this study: PubMed 33416257Scheffenbichler FT, Teja B, Wongtangman K, Mazwi N, Waak K, Schaller SJ, Xu X, Barbieri S, Fagoni N, Cassavaugh J, Blobner M, Hodgson CL, Latronico N, Eikermann M. Effects of the Level and Duration of Mobilization Therapy in the Surgical ICU on the Loss of the Ability to Live Independently: An International Prospective Cohort Study. Crit Care Med. 2021 Mar 1;49(3):e247-e257. doi: 10.1097/CCM.0000000000004808.
- Individual participant dataSharing planned: No
Related trials for Sarcopenia
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
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.
Matthias Eikermann, MD PhD principal investigator
Massachusetts General Hospital
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Muscle Weakness, run by Massachusetts General Hospital at 3 sites in 3 countries.
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 3 inclusion and 8 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 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Germany, Italy. 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 Matthias Eikermann, MD PhD ((617) 726-3030, meikermann@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Hospital Discharge Disposition (time frame: Patient will be followed until hospital discharge, an expected 3 to 30 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 NCT03196960, which also lists 7 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 6 Sep 2018.