Preventing the Loss of Muscle and Function in Hospitalized Older Adults

Completed · Not applicable · Has a placebo group

Conditions studied: Muscular Atrophy

In brief

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).

Key facts

Study ID

NCT02566590

Run by

University of Utah

People needed

20

Starts

2015-01-01

Expected to finish

2016-12-01

Last updated by the study team

2019-04-23

Who can join

Age: 60 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age between 60-85 yrs Ability to sign informed consent Montreal cognitive assessment (MOCA) exam score ≥26 Free-living, prior to admission

You may not qualify if…

• 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)
• 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

Where it is running

• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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