Targeting Oxidative Stress to Prevent Vascular and Skeletal Muscle Dysfunction During Disuse

Launched by JOEL TRINITY · Apr 16, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how inactivity, especially in older adults, can lead to problems with blood vessels and muscle strength. When people are less active, they can experience a decline in their physical health, which is particularly concerning for older adults who may already be facing challenges due to aging. The researchers want to understand the role of oxidative stress—an imbalance in the body that can cause damage—to find ways to prevent these health issues and help maintain better muscle and blood vessel function as people age.

To participate in this study, individuals must be between the ages of 65 and 85, able to provide consent, and have a good score on a cognitive test. However, those with certain health conditions, such as severe heart disease, uncontrolled diabetes, or recent cancer treatment, will not be eligible. Participants can expect to engage in a controlled environment where their health will be monitored, and they may be asked to limit certain activities for a period. This study is actively recruiting, aiming to find solutions that could benefit older adults facing physical decline due to inactivity.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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