Status:
RECRUITING
Targeting Oxidative Stress to Prevent Vascular and Skeletal Muscle Dysfunction During Disuse
Lead Sponsor:
Joel Trinity
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Aging
Oxidative Stress
Eligibility:
All Genders
65-85 years
Phase:
NA
Brief Summary
Prolonged periods of reduced activity are associated with decreased vascular function and muscle atrophy. Physical inactivity due to acute hospitalization is also associated with impaired recovery, ho...
Detailed Description
Disuse following injury or during acute hospitalization is associated with a host of negative outcomes including functional deficiencies, hospital readmission, disability, and increased mortality. Old...
Eligibility Criteria
Inclusion
- Age between 65-85 yrs
- Ability to sign informed consent
- Montreal cognitive assessment (MOCA) exam score greater-than or equal to 26 4. Free-living, prior to admission
Exclusion
- Cardiac abnormalities considered exclusionary by the study physician (e.g., congestive heart failure (CHF), coronary artery disease (CAD), right-to-left shunt)
- Uncontrolled endocrine or metabolic disease (e.g., hypo/hyperthyroidism, diabetes)
- Glomerular filtration rate (GFR) less-than 30 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 greater-than 250 mg/dl, claudication or evidence of venous or arterial insufficiency upon palpitation of femoral, popliteal and pedal arteries)
- Risk of deep vein thrombosis (DVT) including family history of thrombophilia, DVT, pulmonary emboli, myeloproliferative diseases including polycythemia (Hb greater-than 18 g/dL) or thrombocytosis (platelets greater-than 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 greater-than 150 or a diastolic blood pressure greater-than 100 (treated or untreated)
- 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 greater-than 35 kg/m2 (a BMI of 35 kg/m2, which includes individuals that fall into to the Class I obesity category, has been selected to improve inclusion and generalizability to a greater percentage of the general population).
- Inability to abstain from smoking for duration of study
- A history of greater-than 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 (less-than 12 months) of GI bleed
- Depression \[greater-than 5 on the 15 items Geriatric Depression Scale (GDS)\]
- Alcohol abuse (greater-than 2 drinks per day) or drug abuse (inappropriate use of prescription medications or use of any illicit/illegal drugs for recreational use)
- Exercise training (greater-than 1 session of moderate to high intensity aerobic or resistance exercise/week)
- Liver disease (aspartate aminotransferase/alanine aminotransferase 2 times above the normal limit, hyperbilirubinemia)
- Respiratory disease (acute upper respiratory infection, history of chronic lung disease with resting oxygen saturation less-than 97% on room air)
- Currently taking a mitochondrial targeted antioxidant or similarly acting nutraceutical
- Unwilling to cease dietary supplements 4 weeks prior to initiation of bed rest
- Participated in similar bed rest study during last 12 months
- Any other condition or event considered exclusionary by the PI and faculty physician
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04351113
Start Date
September 1 2019
End Date
December 31 2025
Last Update
April 23 2025
Active Locations (1)
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1
VA Medical Center
Salt Lake City, Utah, United States, 84148