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NCT Number: NCT04872998

Vascular Dysfunction During Physical Inactivity

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.

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Key information

Conditions

Aging Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Skeletal Muscle Vascular Endothelium

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Medical Center Building

Salt Lake City, Utah, 84148, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Step Count Reduction

Behavioral

Subjects reduce daily step counts by approximately 70% through monitoring and recording from step-count monitor

Primary outcomes

  1. 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

  1. Popliteal Artery Vascular Function

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

    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.

  2. Leg Microvascular Function

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

    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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

Vascular Dysfunction During Physical Inactivity: Role of Oxidative Stress

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 5, 2021
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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