AgingNCT04872998
Vascular Dysfunction During Physical Inactivity
A study testing Step Count Reduction in people with Aging and Vascular Endothelium, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Vascular Endothelium, Skeletal Muscle
- What is being tested?
- Step Count Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2019to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals who have recently undergone surgery or injury requiring inactivity
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center Building
Salt Lake City, Utah, 84148
About this study
Official title: Vascular Dysfunction During Physical Inactivity: Role of Oxidative Stress
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
- Being tested
- Step Count Reduction
- Keywords
- Reduced Activity, Muscular Atrophy, Vascular Dysfunction
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step Count ReductionBehavioural
Subjects reduce daily step counts by approximately 70% through monitoring and recording from step-count monitor
| Study group | Role | What they receive |
|---|---|---|
| Reduced Activity | Experimental | Reduction of daily step count by 70% for two weeks, followed by two week recovery to normal activity level Receives: Behavioral: Step Count Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, during reduced activity (2 weeks) and 2 weeks post reduced activity (4 weeks)
Secondary outcomes (2)
Popliteal Artery Vascular Function
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.
Measured: Baseline, during reduced activity (2 weeks) and 2 weeks post reduced activity (4 weeks)
Leg Microvascular Function
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.
Measured: Baseline, during reduced activity (2 weeks) and 2 weeks post reduced activity (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start15 Mar 2019
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Joel Trinity, University of Utah
- Investigators
- Joel D Trinity, Ph.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872998
- Sponsor's protocol ID
- IRB #111321
- Other IDs
- UL1TR002538
- Status last verified
- Aug 2021
- First submitted
- 29 Apr 2021
- Last updated
- 20 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Dysfunction During Physical Inactivity: Role of Oxidative Stress
- ClinicalTrials.gov ID
- NCT04872998
- Acronym / sponsor ID
- IRB #111321
- Conditions
- Aging, Vascular Endothelium, Skeletal Muscle
- Keywords
- Reduced Activity, Muscular Atrophy, Vascular Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 5 May 2021 (actual)
- Results
- Posted 16 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reduced Activity | Experimental | Behavioral: Step Count ReductionReduction of daily step count by 70% for two weeks, followed by two week recovery to normal activity level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals who have recently undergone surgery or injury requiring inactivity
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Step Count ReductionSubjects reduce daily step counts by approximately 70% through monitoring and recording from step-count monitor | Behavioural | Reduced Activity |
Primary outcome
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.
2 secondary outcomes
Popliteal Artery Vascular Function
Time frame: Baseline, during reduced activity (2 weeks) and 2 weeks post reduced activity (4 weeks)
Leg Microvascular Function
Time frame: Baseline, during reduced activity (2 weeks) and 2 weeks post reduced activity (4 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel D Trinity, Ph.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Step Count Reduction in people with Aging and Vascular Endothelium, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial Artery Vascular Function (time frame: Baseline, during reduced activity (2 weeks) and 2 weeks post reduced activity (4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.