Role of Aging and Individual Variation in Exercise Training Responsiveness
NCT Number: NCT06471569
Acronym: STRRIDE IV
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prediabetic State|Cardiovascular Diseases|Insulin Resistance|Obesity
Interventions: BEHAVIORAL: Low/Mod|BEHAVIORAL: High/Mod|BEHAVIORAL: High/Vig
Sponsor: Duke University
Collaborators: National Institutes of Health (NIH)|National Institute on Aging (NIA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 8
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2025-09

Summary:
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 8 participants to complete a 6-month aerobic exercise intervention.

Primary Outcome Measures: 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)
Secondary Outcome Measures: Perceived global physical Health, Self-reported health outcomes (including global physical health) will be captured using the Patient-Reported Outcomes Measurement Information System (PROMIS)., Baseline, early-intervention (~6 weeks), and post-intervention (~24 weeks)|Perceived global mental Health, Self-reported health outcomes (including global mental health) will be captured using the Patient-Reported Outcomes Measurement Information System (PROMIS)., Baseline, early-intervention (~6 weeks), and post-intervention (~24 weeks)|Health-Related Quality of Life, Self-reported quality of life outcomes 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., Baseline, early-intervention (~6 weeks), and post-intervention (~24 weeks)|Metabolic Syndrome Score, Continuous metabolic syndrome scores are calculated using differences between Adult Treatment Panel III guideline values and participant values for mean arterial blood pressure, minimal waist circumference, fasting HDL-C, triglycerides, and glucose with normalization to the cohort standard deviations., Baseline, early-intervention (~6 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)|Physical Function, The Short Physical Performance Battery will objectively assess lower extremity function related to gait, balance, and strength in older adults. The 6-minute walk test will provide a measure of functional status or fitness., Baseline, early-intervention (~6 weeks), and post-intervention (~24 weeks)