Vascular Dysfunction During Physical Inactivity

Aging Clinical Trial

Official title:

Vascular Dysfunction During Physical Inactivity: Role of Oxidative Stress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04872998
• Other study ID #: IRB #111321
• Status: Completed
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: August 2021
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prolonged periods of reduced activity are associated with decreased vascular function and muscle atrophy. Physical inactivity due to a sedentary lifestyle or acute hospitalization is also associated with impaired recovery, hospital readmission, and increased mortality. Older adults are a particularly vulnerable population as functional (vascular and skeletal muscle mitochondrial dysfunction) and structural deficits (loss in muscle mass leading to a reduction in strength) are a consequence of the aging process. The combination of inactivity and aging poses an added health threat to these individuals by accelerating the negative impact on vascular and skeletal muscle function and dysfunction. The underlying factors leading to vascular and skeletal muscle dysfunction are unknown, but have been linked to increases in oxidative stress. Additionally, there is a lack of understanding of how vascular function is impacted by inactivity in humans and how these changes are related to skeletal muscle function. It is the goal of this study to investigate the mechanisms that contribute to disuse muscle atrophy and vascular dysfunction in order to diminish their negative impact, and preserve vascular and skeletal muscle function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Individuals who have recently undergone surgery or injury requiring inactivity

Exclusion Criteria:

• Cardiac abnormalities considered exclusionary by the study physician (congestive heart failure, coronary artery disease, right-to-left shunt)

• Uncontrolled endocrine or metabolic disease

• Glomerular filtration rate < 45 mL/min/1.73 m^2 or evidence of kidney disease or failure

• Vascular disease or risk factors of peripheral atherosclerosis

• Risk of deep vein thrombosis including family history of thrombophilia, pulmonary emboli, deep vein thrombosis

• Use of anticoagulant therapy

• Elevated systolic pressure > 180 or a diastolic blood pressure > 110

• Implanted electronic devices such as pacemakers, 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 > 35 kg/m^2

• Inability to abstain from smoking for duration of study

• History of > 20 pack per year smoking

• Positive for human immunodeficiency virus, hepatitis B or hepatitis C

• Recent anabolic or corticosteroids use (within 3 months)

• Subjects with hemoglobin or hematocrit lower than accepted lab values

• Agitation/aggression disorder

• History of stroke with motor disability

• Recent history (< 12 months) of gastrointestinal bleed

• Depression diagnosis

• Alcohol or drug abuse

• Liver disease (AST/ALT 2 times above the normal limit, hyperbilirubinemia)

• Respiratory disease (acute upper respiratory infection, history of chronic lung disease with resting oxygen saturation < 97% on room air)

• Pregnancy

Related Conditions & MeSH terms

• Aging
• Skeletal Muscle
• Vascular Endothelium

Intervention

Behavioral:
• Step Count Reduction
Subjects reduce daily step counts by approximately 70% through monitoring and recording from step-count monitor

Locations

Country	Name	City	State
United States	VA Medical Center Building	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	University of Utah Center for Clinical and Translational Science (CCTS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brachial Artery Vascular Function	The flow rate of brachial artery measured by flow-mediated dilation (FDM). Doppler ultrasound will be used to determine brachial artery vascular function. Specifically, this assessment will include the measurement of flow rate and artery diameter at rest and in response to flow mediated dilation.	Baseline, during reduced activity (2 weeks) and 2 weeks post reduced activity (4 weeks)
Secondary	Popliteal Artery Vascular Function	Flow rate of popliteal artery measured by flow-mediated dilation (FMD). Doppler ultrasound will be used to determine popliteal artery vascular function. Specifically, this assessment will include the measurement of flow rate and artery diameter at rest and in response to flow mediated dilation.	Baseline, during reduced activity (2 weeks) and 2 weeks post reduced activity (4 weeks)
Secondary	Leg Microvascular Function	Flow rate of leg microvasculature assessed by passive leg movement (PLM). Doppler ultrasound will be used to determine leg microvasculature function. Specifically, this assessment will include the measurement of flow rate at rest and in response to movement.	Baseline, during reduced activity (2 weeks) and 2 weeks post reduced activity (4 weeks)