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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR002538 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced Activity | Experimental | Reduction of daily step count by 70% for two weeks, followed by two week recovery to normal activity level |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Step Count Reduction | Behavioral | Subjects reduce daily step counts by approximately 70% through monitoring and recording from step-count monitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, during reduced activity (2 weeks) and 2 weeks post reduced activity (4 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel D Trinity, Ph.D. | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center Building | Salt Lake City | Utah | 84148 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reduced Activity | Reduction of daily step count by 70% for two weeks Step Count Reduction: Subjects reduce daily step counts by approximately 70% through monitoring and recording from step-count monitor |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Reduced Activity | Reduction of daily step count by 70% for two weeks Step Count Reduction: Subjects reduce daily step counts by approximately 70% through monitoring and recording from step-count monitor |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percent vasodilation | Baseline, during reduced activity (2 weeks) and 2 weeks post reduced activity (4 weeks) |
|
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reduced Activity | Reduction of daily step count by 70% for two weeks Step Count Reduction: Subjects reduce daily step counts by approximately 70% through monitoring and recording from step-count monitor |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator Joel Trinity Associate Professor | University of Utah | 801-582-1565 | joel.trinity@utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2018 | Jul 22, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 15, 2021 | Mar 24, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
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| 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. | Baseline, during reduced activity (2 weeks) and 2 weeks post reduced activity (4 weeks) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percent vasodilation | Baseline, during reduced activity (2 weeks) and 2 weeks post reduced activity (4 weeks) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | ml/min | Baseline, during reduced activity (2 weeks) and 2 weeks post reduced activity (4 weeks) |
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
|