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| ID | Type | Description | Link |
|---|---|---|---|
| R21AR073422 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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This is an interventional study enrolling older individuals aged 60-85y to observe changes during physical inactivity. This study is investigating the relation between short-term physical inactivity and the impact of muscle health and function. The enrollment goal is 8 participants. The study will occur over the course of a month where participants will undergo testing before and after a reduction in physically activity levels. There will be a screening event collecting baseline data, two body composition scans, muscle function and oral glucose tolerance tests and a metabolic study before and after a 2-week period of inactivity. Each metabolic study will entail three-muscle biopsies: one before and 2 after the ingestion of leucine.
Pre-testing- The baseline evaluation will assess muscle function and strength, and an oral glucose tolerance test. After the baseline visit, participants will be provided with a step activity monitor to track their level of activity. This will provide a baseline of the participant's normal level of physical activity so an accurate level of 75% activity reduction can be determined. A 3-day daily dietary diary will be provided for the participant to self-report prior to the experiment, as well.
Day 1- After the participant completes their normal activity log and dietary diary, they will be asked to return to the research center for a body composition scan and a metabolic study.
The metabolic study will involve blood sampling from an arm vein and muscle biopsies from the thigh before and after a leucine drink.
2-week period of inactivity- After the metabolic study, the participant will return home and maintain a reduced level of activity (75% reduction) for a two-week period. During this time, the participant will receive phone calls from research personnel in order to maintain adherence to the intervention.
Day 14- After the 2-week reduced activity period, the participant will return to the research center to receive a body composition scan and undergo a metabolic study identical to 'Day 1'.
Post-testing- After Day 14, the participant will be asked to return once again to the research center for a oral glucose tolerance test and the exercise lab for muscle function testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced Physical Activity | Experimental | Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced Physical Activity | Other | Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity. |
| Measure | Description | Time Frame |
|---|---|---|
| Lean Mass | Change in lean mass | baseline and 2-weeks |
| Strength | Change in muscle strength | baseline and 2-weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Micah Drummond | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84112 | United States |
No plan has been put into place
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| ID | Title | Description |
|---|---|---|
| FG000 | Reduced Physical Activity | Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity Reduced Physical Activity: Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Reduced Physical Activity | Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity Reduced Physical Activity: Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Lean Mass | Change in lean mass | Posted | Mean | Standard Error | grams | baseline and 2-weeks |
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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 Physical Activity | Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity Reduced Physical Activity: Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Micah Drummond | The University of Utah | 801-213-2737 | micah.drummond@hsc.utah.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 24, 2018 | May 31, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Participants will be tested before and 2-weeks after they have reduced their level of physical activity
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| HbA1c | Mean | Standard Deviation | % of hemoglobin |
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| Primary | Strength | Change in muscle strength | Posted | Mean | Standard Error | percentage of leg strength | baseline and 2-weeks |
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| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
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