Muscular AtrophyNCT02566590
Preventing the Loss of Muscle and Function in Hospitalized Older Adults
A study testing NMES and Protein in people with Muscular Atrophy, run by University of Utah at 1 site in United States.
Trial summary
One third of independent older adults over the age of 65y will be hospitalized for an acute medical illness, injury, or operative procedure. Unfortunately, 50% of these older adults will experience functional decline during their hospital stay from the amount of time they are physically inactive and in bed. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscular Atrophy
- What is being tested?
- NMES and Protein
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 60-85 yrs Ability to sign informed consent Montreal cognitive assessment (MOCA) exam score ≥26 Free-living, prior to admission
Who cannot join
- Cardiac abnormalities considered exclusionary by the study physician (e.g., CHF, CAD, right-to-left shunt)
- Uncontrolled endocrine or metabolic disease (e.g., hypo/hyperthyroidism, diabetes)
- GFR <65 mL/min/1.73m2 or evidence of kidney disease or failure
- Vascular disease or risk factors of peripheral atherosclerosis. (e.g., uncontrolled hypertension, obesity, diabetes, hypercholesterolemia > 250 mg/dl, claudication or evidence of venous or arterial insufficiency upon palpitation of femoral, popliteal and pedal arteries)
- Risk of DVT including family history of thrombophilia, DVT, pulmonary emboli, myeloproliferative diseases including polycythemia (Hb>18 g/dL) or thrombocytosis (platelets>400x103/mL), and connective tissue diseases (positive lupus anticoagulant), hyperhomocysteinemia, deficiencies of factor V Leiden, proteins S and C, and antithrombin III
- Use of anticoagulant therapy (e.g., Coumadin, heparin)
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- Elevated systolic pressure >150 or a diastolic blood pressure > 100
- Implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators)
- Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma
- Currently on a weight-loss diet or body mass index > 30 kg/m2
- Inability to abstain from smoking for duration of study
- A history of > 20 pack per year smoking
- HIV or hepatitis B or C*
- Recent anabolic or corticosteroids use (within 3 months)
- Subjects with hemoglobin or hematocrit lower than accepted lab values
- Agitation/aggression disorder (by psychiatric history and exam)
- History of stroke with motor disability
- A recent history (<12 months) of GI bleed
- Depression [>5 on the 15 items Geriatric Depression Scale (GDS)]
- Alcohol or drug abuse
- Exercise training (>1 session of moderate to high intensity aerobic or resistance exercise/week)
- Liver disease (AST/ALT 2 times above the normal limit, hyperbilirubinemia)
- Respiratory disease (acute upper respiratory infection, history of chronic lung disease with resting oxygen saturation <97% on room air)
- Any other condition or event considered exclusionary by the PI and faculty physician
Trial locations and contacts
1 site in 1 country.
About this study
One third of independent older adults over the age of 65y will be hospitalized for an acute medical illness, injury, or operative procedure. Unfortunately, 50% of these older adults will experience functional decline during their hospital stay from the amount of time they are physically inactive and in bed. Following discharge, the functional deficits can persist for months and in many instances never return to pre-hospitalization levels thus compounding morbidity, health care costs and dying. A classic consequence of short-term bed rest in older adults is the significant loss in skeletal muscle mass which underlies the accelerated leg strength deficits. The investigator has shown that an important mechanism of skeletal muscle loss is the inability of nutrients to stimulate a normal muscle protein synthesis response; a process highly regulated by the mammalian target of rapamycin signaling pathway (mTOR) and amino acid transporters. Day to day maintenance of force generating muscle tissue is dictated by anabolic stimulation from muscle contraction and essential amino acid ingestion. Therefore, anabolic interventions such as neuromuscular electrical stimulation (NMES) and high quality protein supplementation that contains a high proportion of essential amino acids (whey protein) may be promising approach to maintain leg muscle mass and strength in hospitalized older adults and prevent the long term consequences of repeated periods of short-term physical inactivity. The purpose of this study is to test in older adults if the combination of NMES and protein supplementation is capable of preserving muscle mass and strength and maintaining muscle nutrient anabolic sensitivity during bed rest. The investigators current hypotheses are that daily NMES and protein supplementation during 5-days of bed rest in older adults will: 1) preserve lower extremity muscle mass and strength and 2) maintain muscle nutrient anabolic sensitivity as measured by mTOR signaling and amino acid transporter expression. The long term goal is to utilize this inpatient preventative therapeutic approach in a clinical setting in which muscle mass and strength deficits are profound (e.g., intensive care patients).
Read the detailed description
A majority of older adults experience repeated periods of physical inactivity during acute illnesses, injuries or after an operative procedure. Following discharge from the hospital, daily activities are adversely impacted. Infirmity follows repeated periods of inactivity (termed "catabolic hits") that can occur over an older adults' lifespan and lead to a downward spiral of potentially irrecoverable deficits in physical function resulting in increased health care costs, loss of independence, and premature death. The hallmark sign of short-term physical inactivity in older adults is the rapid deterioration of skeletal muscle mass and strength. Understandably, little attention is placed on physical function during these requisite periods of inactivity as the medical management and/or postoperative recuperation is the focus. However, the muscle deficits that follow as a result of acute hospitalization can have profound long-term consequences.
Muscle contraction and essential amino acids are powerful independent anabolic stimuli and fundamental to maintain skeletal muscle mass and strength. The primary mechanism of disuse atrophy during short-term bed rest in older adults is the reduced acute nutrient stimulation of muscle protein synthesis regulated by the mammalian target of rapamycin (mTOR) signaling pathway and amino acid transporter expression (i.e., LAT1). Intervening with essential amino acid supplements can maintain some muscle function in older adults during bed rest, but it does not preserve muscle mass. Neuromuscular electrical stimulation (NMES) as a muscle intervention is also feasible, but alone is not a panacea. NMES has recently been shown to acutely stimulate protein synthesis in ambulatory older adults with diabetes and attenuate some loss in muscle mass in critically ill patients. The investigator suggests that, together, daily NMES, and a high quality protein source of EAAs (PRO), can be a potent two-pronged approach to preserve the loss of muscle and strength in older adults confined to short-term bed rest. The goal is to test if the combination of NMES and PRO will maintain muscle mass, strength, nutrient-induced mTOR signaling and amino acid transporter expression in older adults during bed rest. The central hypothesis for this project which will support this next step is that a daily combination of NMES and PRO in older adults experiencing bed rest will preserve: 1) leg muscle mass and knee extensor strength and 2) muscle anabolic sensitivity in response to acute nutrient ingestion, as measured by mTOR signaling and LAT1 expression.
- Conditions
- Muscular Atrophy
- Being tested
- NMES, Protein, non-protein placebo supplement
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMESDevice
device is used to stimulate muscle contraction in the legs of the patient. The intervention will be used 3 times a day during bed rest.
ProteinDietary supplement
supplement will used to enhance muscle anabolism. The intervention will be provided 3 times a day during bed rest.
non-protein placebo supplementDietary supplement
supplement will be used as a placebo to control participants. The supplement will be provided 3x a day during bed rest.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Participants will complete bed rest but will receive a non-protein placebo supplement Receives: Dietary Supplement: non-protein placebo supplement |
| NMES + PRO | Experimental | Participants will receive daily treatment with neuromuscular electrical stimulation (NMES) and daily supplements of a protein drink. Receives: Device: NMES; Dietary Supplement: Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percent Change in Bilateral Thigh Lean Mass Density (Grams) as Measured by DEXA Scan Will be Compared Between Baseline and After 5-days of Bed Rest
Thigh lean mass (grams) will be measured by DEXA scan at baseline and after 5-days of bed rest. The change in thigh lean mass will be calculated between these two time points. This outcome will be measured for the Control and the NMES + PRO groups.
Measured: Baseline and after 5-days of Bed rest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Muscular AtrophyStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Micah Drummond, University of Utah
- Investigators
- Micah Drummond, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566590
- Sponsor's protocol ID
- 72083
- Status last verified
- Oct 2018
- First submitted
- 23 Sep 2015
- Last updated
- 23 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing the Loss of Muscle and Function in Hospitalized Older Adults
- ClinicalTrials.gov ID
- NCT02566590
- Acronym / sponsor ID
- 72083
- Conditions
- Muscular Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Posted 16 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One third of independent older adults over the age of 65y will be hospitalized for an acute medical illness, injury, or operative procedure. Unfortunately, 50% of these older adults will experience functional decline during their hospital stay from the amount of time they are physically inactive and in bed. Following discharge, the functional deficits can persist for months and in many instances never return to pre-hospitalization levels thus compounding morbidity, health care costs and dying. A classic consequence of short-term bed rest in older adults is the significant loss in skeletal muscle mass which underlies the accelerated leg strength deficits. The investigator has shown that an important mechanism of skeletal muscle loss is the inability of nutrients to stimulate a normal muscle protein synthesis response; a process highly regulated by the mammalian target of rapamycin signaling pathway (mTOR) and amino acid transporters. Day to day maintenance of force generating muscle tissue is dictated by anabolic stimulation from muscle contraction and essential amino acid ingestion. Therefore, anabolic interventions such as neuromuscular electrical stimulation (NMES) and high quality protein supplementation that contains a high proportion of essential amino acids (whey protein) may be promising approach to maintain leg muscle mass and strength in hospitalized older adults and prevent the long term consequences of repeated periods of short-term physical inactivity. The purpose of this study is to test in older adults if the combination of NMES and protein supplementation is capable of preserving muscle mass and strength and maintaining muscle nutrient anabolic sensitivity during bed rest. The investigators current hypotheses are that daily NMES and protein supplementation during 5-days of bed rest in older adults will: 1) preserve lower extremity muscle mass and strength and 2) maintain muscle nutrient anabolic sensitivity as measured by mTOR signaling and amino acid transporter expression. The long term goal is to utilize this inpatient preventative therapeutic approach in a clinical setting in which muscle mass and strength deficits are profound (e.g., intensive care patients).
Detailed description
A majority of older adults experience repeated periods of physical inactivity during acute illnesses, injuries or after an operative procedure. Following discharge from the hospital, daily activities are adversely impacted. Infirmity follows repeated periods of inactivity (termed "catabolic hits") that can occur over an older adults' lifespan and lead to a downward spiral of potentially irrecoverable deficits in physical function resulting in increased health care costs, loss of independence, and premature death. The hallmark sign of short-term physical inactivity in older adults is the rapid deterioration of skeletal muscle mass and strength. Understandably, little attention is placed on physical function during these requisite periods of inactivity as the medical management and/or postoperative recuperation is the focus. However, the muscle deficits that follow as a result of acute hospitalization can have profound long-term consequences.
Muscle contraction and essential amino acids are powerful independent anabolic stimuli and fundamental to maintain skeletal muscle mass and strength. The primary mechanism of disuse atrophy during short-term bed rest in older adults is the reduced acute nutrient stimulation of muscle protein synthesis regulated by the mammalian target of rapamycin (mTOR) signaling pathway and amino acid transporter expression (i.e., LAT1). Intervening with essential amino acid supplements can maintain some muscle function in older adults during bed rest, but it does not preserve muscle mass. Neuromuscular electrical stimulation (NMES) as a muscle intervention is also feasible, but alone is not a panacea. NMES has recently been shown to acutely stimulate protein synthesis in ambulatory older adults with diabetes and attenuate some loss in muscle mass in critically ill patients. The investigator suggests that, together, daily NMES, and a high quality protein source of EAAs (PRO), can be a potent two-pronged approach to preserve the loss of muscle and strength in older adults confined to short-term bed rest. The goal is to test if the combination of NMES and PRO will maintain muscle mass, strength, nutrient-induced mTOR signaling and amino acid transporter expression in older adults during bed rest. The central hypothesis for this project which will support this next step is that a daily combination of NMES and PRO in older adults experiencing bed rest will preserve: 1) leg muscle mass and knee extensor strength and 2) muscle anabolic sensitivity in response to acute nutrient ingestion, as measured by mTOR signaling and LAT1 expression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Dietary Supplement: non-protein placebo supplementParticipants will complete bed rest but will receive a non-protein placebo supplement |
| NMES + PRO | Experimental | Device: NMES, Dietary Supplement: ProteinParticipants will receive daily treatment with neuromuscular electrical stimulation (NMES) and daily supplements of a protein drink. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age between 60-85 yrs Ability to sign informed consent Montreal cognitive assessment (MOCA) exam score ≥26 Free-living, prior to admission
Key exclusion criteria (24 listed)
- Cardiac abnormalities considered exclusionary by the study physician (e.g., CHF, CAD, right-to-left shunt)
- Uncontrolled endocrine or metabolic disease (e.g., hypo/hyperthyroidism, diabetes)
- GFR <65 mL/min/1.73m2 or evidence of kidney disease or failure
- Vascular disease or risk factors of peripheral atherosclerosis. (e.g., uncontrolled hypertension, obesity, diabetes, hypercholesterolemia > 250 mg/dl, claudication or evidence of venous or arterial insufficiency upon palpitation of femoral, popliteal and pedal arteries)
- Risk of DVT including family history of thrombophilia, DVT, pulmonary emboli, myeloproliferative diseases including polycythemia (Hb>18 g/dL) or thrombocytosis (platelets>400x103/mL), and connective tissue diseases (positive lupus anticoagulant), hyperhomocysteinemia, deficiencies of factor V Leiden, proteins S and C, and antithrombin III
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 |
|---|---|---|
| NMESdevice is used to stimulate muscle contraction in the legs of the patient. The intervention will be used 3 times a day during bed rest. | Device | NMES + PRO |
| Proteinsupplement will used to enhance muscle anabolism. The intervention will be provided 3 times a day during bed rest. | Dietary supplement | NMES + PRO |
| non-protein placebo supplementsupplement will be used as a placebo to control participants. The supplement will be provided 3x a day during bed rest. | Dietary supplement | Control |
Primary outcome
The Percent Change in Bilateral Thigh Lean Mass Density (Grams) as Measured by DEXA Scan Will be Compared Between Baseline and After 5-days of Bed Rest
Time frame: Baseline and after 5-days of Bed rest
Thigh lean mass (grams) will be measured by DEXA scan at baseline and after 5-days of bed rest. The change in thigh lean mass will be calculated between these two time points. This outcome will be measured for the Control and the NMES + PRO groups.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Micah Drummond, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES and Protein in people with Muscular Atrophy, run by University of Utah at 1 site in United States.
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 1 inclusion and 24 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: finished, as of the sponsor's last update on 23 Apr 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 16 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Percent Change in Bilateral Thigh Lean Mass Density (Grams) as Measured by DEXA Scan Will be Compared Between Baseline and After 5-days of Bed Rest (time frame: Baseline and after 5-days of Bed rest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2019.