Preventing the Loss of Muscle and Function in Hospitalized Older Adults

NCT02566590 | Completed Results DMC

• 1 other identifier: 72083
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Muscular Atrophy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and after 5-days of Bed rest

Study Arms (2)

Control

EXPERIMENTAL

Participants will complete bed rest but will receive a non-protein placebo supplement

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.

Device: NMES; Dietary Supplement: Protein

Interventions

NMES DEVICE

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.

NMES + PRO

Protein DIETARY_SUPPLEMENT

supplement will used to enhance muscle anabolism. The intervention will be provided 3 times a day during bed rest.

NMES + PRO

non-protein placebo supplement DIETARY_SUPPLEMENT

supplement will be used as a placebo to control participants. The supplement will be provided 3x a day during bed rest.

Control

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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)

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Muscular Atrophy

Interventions

Proteins

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Micah Drummond
• Organization: University of Utah

micah.drummond@hsc.utah.edu

8015877764

Study Officials

• Micah Drummond, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: October 2, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 23, 2019
• Results First Posted: April 16, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)