Vascular Dysfunction During Physical Inactivity

• Sponsor: University of Utah (Other)
• Overall Status: Completed
• CT.gov ID: NCT04872998
• Collaborator: University of Utah Center for Clinical and Translational Science (CCTS) (Other)
• Enrollment: 13
• Location: 1
• Arm: 1
• Actual Duration (Months): 24.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aging; Vascular Endothelium; Skeletal Muscle	Behavioral: Step Count Reduction	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Vascular Dysfunction During Physical Inactivity: Role of Oxidative Stress
• Actual Study Start Date: Mar 15, 2019
• Actual Primary Completion Date: Mar 31, 2021
• Actual Study Completion Date: Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Reduced Activity Reduction of daily step count by 70% for two weeks	Behavioral: Step Count Reduction; Subjects reduce daily step counts by approximately 70% through monitoring and recording from step-count monitor

Outcome Measures

Primary Outcome Measures

1. Brachial artery vascular function [2 Weeks]

   Flow rate of brachial artery measured by flow-mediated dilation

Secondary Outcome Measures

1. Popliteal artery vascular function [2 Weeks]

   Flow rate of popliteal artery measured by flow-mediated dilation

2. Leg microvascular function [2 Weeks]

   Flow rate of leg microvasculature assessed by passive leg movement and measured by flow-mediated dilation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Medical Center Building	Salt Lake City	Utah	United States	84148

Sponsors and Collaborators

• University of Utah
• University of Utah Center for Clinical and Translational Science (CCTS)

Investigators

• Principal Investigator: Joel D Trinity, Ph.D., University of Utah

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joel Trinity, Associate Professor, University of Utah
• ClinicalTrials.gov Identifier: NCT04872998
• Other Study ID Numbers: IRB #111321
• First Posted: May 5, 2021
• Last Update Posted: Aug 11, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Joel Trinity, Associate Professor, University of Utah: Reduced Activity; Muscular Atrophy; Vascular Dysfunction

Study Results

No Results Posted as of Aug 11, 2021