Preventing muscle and vascular issues in older adults during inactivity

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

This study is testing if using antioxidants and physical therapy can help older adults aged 65-85 prevent muscle and blood vessel problems that can happen when they are inactive for a long time.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 65 Years to 85 Years
• Sex: All
• Sponsor: University of Utah (other)
• Locations: 1 site (Salt Lake City, Utah)
• Trial ID: NCT04351113 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of oxidative stress on vascular and skeletal muscle dysfunction in older adults who experience prolonged inactivity, such as during hospitalization. It aims to understand how inactivity exacerbates these issues and to explore potential interventions, including antioxidants and physical therapies. The study will involve participants aged 65-85 and will assess their vascular and muscle function in response to various treatments. By addressing both vascular and muscular health, the study seeks to develop comprehensive strategies to mitigate the negative impacts of disuse.

Who should consider this trial

Good fit: Ideal candidates for this study are older adults aged 65-85 who are able to provide informed consent and have a cognitive assessment score indicating normal cognitive function.

Not a fit: Patients with significant cardiac abnormalities, uncontrolled endocrine diseases, or severe vascular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved recovery and reduced disability in older adults following periods of inactivity.

How similar studies have performed: While the approach of targeting oxidative stress in this context is relatively novel, similar studies have indicated that addressing both vascular and muscular health can yield positive outcomes.

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

Where this trial is running

Salt Lake City, Utah

• VA Medical Center — Salt Lake City, Utah, United States (RECRUITING)

Study contacts

• Study coordinator: Joel D Trinity, PhD

Conditions: Aging, Oxidative Stress, Vascular Endothelium, Skeletal Muscle, Antioxidants, cardiovascular degeneration, Muscular atrophy