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Clinical Trials/NCT04872998
NCT04872998
Completed
Not Applicable

Vascular Dysfunction During Physical Inactivity: Role of Oxidative Stress

University of Utah1 site in 1 country14 target enrollmentMarch 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aging
Sponsor
University of Utah
Enrollment
14
Locations
1
Primary Endpoint
Brachial Artery Vascular Function
Status
Completed
Last Updated
3 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 15, 2019
End Date
March 31, 2021
Last Updated
3 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joel Trinity

Associate Professor

University of Utah

Eligibility Criteria

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

Outcomes

Primary Outcomes

Brachial Artery Vascular Function

Time Frame: Baseline, during reduced activity (2 weeks) and 2 weeks post reduced activity (4 weeks)

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.

Secondary Outcomes

  • Popliteal Artery Vascular Function(Baseline, during reduced activity (2 weeks) and 2 weeks post reduced activity (4 weeks))
  • Leg Microvascular Function(Baseline, during reduced activity (2 weeks) and 2 weeks post reduced activity (4 weeks))

Study Sites (1)

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