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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30AG028716-18 | U.S. NIH Grant/Contract | View source |
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Enrollment is paused until additional funding is secured.
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Aging (NIA) | NIH |
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The primary purpose of this study is to assess the effects of aging on markers of physical reserve and exercise-induced adaptations in resilience in older adults who completed a structured exercise program within the last 15 years (Parent trial: STRRIDE-PD; NCT00962962). This feasibility pilot study will enroll up to 26 participants to complete a 6-month aerobic exercise intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Amount/Moderate Intensity (Low/Mod) | Experimental | Six months of low amount/moderate intensity aerobic exercise |
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| High Amount/Moderate Intensity (High/Mod) | Experimental | Six months of high amount/moderate intensity aerobic exercise |
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| High Amount/Vigorous Intensity (High/Vig) | Experimental | Six months of high amount/vigorous intensity aerobic exercise |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low/Mod | Behavioral | Aerobic exercise at 50% peak oxygen consumption for the number of weekly minutes prescribed in the original STRRIDE trial |
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| Measure | Description | Time Frame |
|---|---|---|
| Insulin Sensitivity | Insulin sensitivity will be measured with a 2-hour oral glucose tolerance test | Baseline, early-intervention (~6 weeks), and post-intervention (~24 weeks) |
| Cardiorespiratory Fitness | Cardiorespiratory fitness will be measured with a maximal cardiopulmonary exercise test | Baseline, early-intervention (~6 weeks), and post-intervention (~24 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Global Health | Self-reported global health will be captured using the Patient-Reported Outcomes Measurement Information System (PROMIS). The questionnaire will be scored using "response pattern scoring" according to the PROMIS scoring manual in order to calculate the T-score for this outcome measure. The population mean T-score for global health is 50, with a score of 40 considered below average and a score of 60 considered above average. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leanna M Ross, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Center for Living | Durham | North Carolina | 27705 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 14, 2025 | May 18, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D002318 | Cardiovascular Diseases |
| D007333 | Insulin Resistance |
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| High/Mod | Behavioral | Aerobic exercise at 50% peak oxygen consumption for the number of weekly minutes prescribed in the original STRRIDE trial |
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| High/Vig | Behavioral | Aerobic exercise at 75% peak oxygen consumption for the number of weekly minutes prescribed in the original STRRIDE trial |
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| Baseline, early-intervention (~6 weeks), mid-intervention (~12 weeks), and post-intervention (~24 weeks) |
| Health-Related Quality of Life | Health-related quality of life will be captured using the SF-36 Health Survey. The survey is scored into eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Raw scores will be converted into scale scores ranging from 0 to 100, with higher scores representing better health-related quality of life. | Baseline, early-intervention (~6 weeks), mid-intervention (~12 weeks), and post-intervention (~24 weeks) |
| Metabolic Syndrome Z-Score | The metabolic syndrome z-score (MSSc) is a continuous weighted score of the five metabolic syndrome variables-fasting high-density lipoprotein cholesterol, triglycerides, glucose, waist circumference, and mean arterial blood pressure. A modified z-score will be calculated for each participant using continuous differences between the Adult Treatment Panel (ATP) III guideline values and participant values with normalization to the cohort's standard deviations. To account for variations in ATP III criteria between men and women, the investigators will use sex-specific MSSc equations. A lower MSSc indicates a better outcome. | Baseline, early-intervention (~6 weeks), mid-intervention (~12 weeks), and post-intervention (~24 weeks) |
| Body Composition | Body composition will be assessed as percent fat mass and percent fat-free mass. | Baseline and post-intervention (~24 weeks) |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |