Vascular Dysfunction During Physical Inactivity

NCT04872998 | Completed Results

• 2 other identifiers: IRB #111321UL1TR002538
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Vascular Endothelium; Skeletal Muscle

Keywords

Reduced Activity; Muscular Atrophy; Vascular Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Arms (1)

Reduced Activity

EXPERIMENTAL

Reduction of daily step count by 70% for two weeks, followed by two week recovery to normal activity level

Behavioral: Step Count Reduction

Interventions

Step Count Reduction BEHAVIORAL

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

Reduced Activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who have recently undergone surgery or injury requiring inactivity

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

VA Medical Center Building

Salt Lake City, Utah, 84148, United States

Location

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Results Point of Contact

• Title: Principal Investigator Joel Trinity Associate Professor
• Organization: University of Utah

joel.trinity@utah.edu

801-582-1565

Study Officials

• Joel D Trinity, Ph.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 5, 2021
• Study Start: March 15, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: January 20, 2026
• Results First Posted: February 16, 2024

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)