Preserving Muscle Mass and Function in Bedridden Older Adults

Completed · Not applicable

Conditions studied: Bed Rest

In brief

The investigators propose that low-intensity exercise and supplementing daily meals with leucine or whey will independently and synergistically reduce the deleterious effects of inactivity on skeletal muscle and facilitate recovery during rehabilitation.

Key facts

Study ID

NCT01846130

Run by

The University of Texas Medical Branch, Galveston

People needed

123

Starts

2013-01-01

Expected to finish

2018-12-01

Last updated by the study team

2019-01-24

Who can join

Age: 60 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age between 60-80
• Ability to sign informed consent
• Ability to pass a mini-mental status exam
• Free-living, prior to admission

You may not qualify if…

• Subjects with cardiac abnormalities considered exclusionary by the study physicians
• Subjects with uncontrolled metabolic disease
• A glomerular filtration rate (GRF) <65 mL/min/1.73m2 or evidence of kidney disease or failure
• Subjects with 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.
• Any history of hypo- or hyper-coagulation disorders. (e.g., Coumadin use or history of deep vein thrombosis (DVT) or PE).
• Subjects with chronically elevated systolic pressure >170 or a diastolic blood pressure > 100.
• Subjects with implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators)
• Subjects with recently (6 months) treated cancer other than basal cell carcinoma
• Any subject currently on a weight-loss diet or a body mass index > 30 kg/m2.
• A history of > 20 pack per year smoking and/or inability to abstain from smoking for duration of study
• Any subject that is HIV-seropositive or has active hepatitis
• Recent anabolic or corticosteroids use (within 3 months).
• Subjects with hemoglobin or hematocrit lower than accepted lab values.
• Dementia, agitation/aggression disorder
• History of stroke with motor disability
• A recent history (<12 months) of GI bleed
• Any other condition or event considered exclusionary by the PI and faculty physician.

Where it is running

• Unversity of Texas Medical Branch — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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