Status:
COMPLETED
Preserving Muscle Mass and Function in Bedridden Older Adults
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Conditions:
Bed Rest
Eligibility:
All Genders
60-80 years
Phase:
NA
Brief Summary
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...
Detailed Description
The loss of muscle mass and function in older adults during bed rest is facilitated by defects in the regulation of muscle protein metabolism, including an impaired ability to mount an anabolic respon...
Eligibility Criteria
Inclusion
- Age between 60-80
- Ability to sign informed consent
- Ability to pass a mini-mental status exam
- Free-living, prior to admission
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT01846130
Start Date
January 1 2013
End Date
December 1 2018
Last Update
January 24 2019
Active Locations (1)
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1
Unversity of Texas Medical Branch
Galveston, Texas, United States, 77555