Vascular Dysfunction During Physical Inactivity

NCT ID: NCT04872998

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-15
• Study Completion Date: 2021-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Reduced Activity

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

Group Type: EXPERIMENTAL

Step Count Reduction

Intervention Type: BEHAVIORAL

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

Interventions

Step Count Reduction

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

Intervention Type: BEHAVIORAL

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Joel Trinity

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joel D Trinity, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

VA Medical Center Building

Salt Lake City, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

UL1TR002538

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB #111321

Identifier Type: -

Identifier Source: org_study_id