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| Name | Class |
|---|---|
| Duke University | OTHER |
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This is a 12-week randomized, controlled trial that seeks to examine the effect of Vivo on 1) change in lower extremity strength defined as number of chair stands done in 30 seconds and 2) change in average glycemic level (HbA1c) compared to a wait list control.
This is a 12-week randomized, controlled trial that seeks to examine the effect of Vivo on 1) change in lower extremity strength defined as number of chair stands done in 30 seconds and 2) change in average glycemic level (HbA1c) compared to a wait list control. After informed consent and baseline assessments, up to 90 individuals will be randomized in one of two arms: 1) Vivo intervention or 2) waitlist control. Participants in the Vivo 2.0 intervention arm will meet virtually twice a week with their small group and certified trainer for 45 minutes over a 12-week period. Participants will be men and women, ≥60 years old, sedentary, with prediabetes and low function. All participants will undergo baseline and 12-week assessments
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vivo intervention | Experimental | Participants will meet virtually twice a week for 12 weeks with their small group and certified trainer for 45 minutes. |
|
| Waitlist control | No Intervention | Participants randomized to this arm will be asked to maintain their baseline physical activity for 12-weeks. They will be scheduled for the baseline and 12-week assessment and following the 12-week assessment, they will be offered enrollment into Vivo. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivo | Behavioral | Participants will meet virtually twice a week with their small group and certified trainer for 45 minutes exercise sessions for a 12-week period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lower body strength | Lower body strength measured by the 30-second chair stand | baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1C (HbA1C) | Hemoglobin A1C (HbA1C) measure during clinic assessment | baseline and 12 weeks |
| Balance | Static Balance Score of the SPPB. Sore 0-4 depending on the combined results of side by side, semi-tandem, and tandem stand tests. |
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Inclusion Criteria:
Exclusion Criteria:
Inability to complete physical function assessment
Use of antidiabetic medications
Use of testosterone supplement or replacement
Clinical disorder precluding/interfering with participation of assessments
Weight instability (defined as gain or loss of ≥10% over the last 6 months)
Unable to provide consent
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D009133 | Muscular Atrophy |
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The PI will be masked to randomization assignment.
| baseline and 12 weeks |
| Physical Activity Level | Average step count using Garmin Fitness Tracker | baseline and 12 weeks |
| Aerobic Endurance | Measured by the 2-minute step test for aerobic endurance | baseline and 12 weeks |
| D004700 | Endocrine System Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010335 | Pathologic Processes |