Role of Aging and Individual Variation in Exercise Training Responsiveness
STRRIDE IV
The Role of Aging and Individual Variation in Exercise Training Responsiveness
2 other identifiers
interventional
26
1 country
1
Brief 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 26 participants to complete a 6-month aerobic exercise intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2024
CompletedFirst Posted
Study publicly available on registry
June 24, 2024
CompletedStudy Start
First participant enrolled
April 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
November 14, 2025
November 1, 2025
2 years
June 10, 2024
November 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Insulin Sensitivity
Insulin sensitivity will be measured with a 2-hour oral glucose tolerance test
Baseline and post-intervention (~24 weeks)
Cardiorespiratory Fitness
Cardiorespiratory fitness will be measured with a maximal cardiopulmonary exercise test
Baseline and post-intervention (~24 weeks)
Secondary Outcomes (4)
Perceived Global Health
Baseline, mid-intervention (~12 weeks), and post-intervention (~24 weeks)
Health-Related Quality of Life
Baseline, mid-intervention (~12 weeks), and post-intervention (~24 weeks)
Metabolic Syndrome Z-Score
Baseline, mid-intervention (~12 weeks), and post-intervention (~24 weeks)
Body Composition
Baseline and post-intervention (~24 weeks)
Study Arms (3)
Low Amount/Moderate Intensity (Low/Mod)
EXPERIMENTALSix months of low amount/moderate intensity aerobic exercise
High Amount/Moderate Intensity (High/Mod)
EXPERIMENTALSix months of high amount/moderate intensity aerobic exercise
High Amount/Vigorous Intensity (High/Vig)
EXPERIMENTALSix months of high amount/vigorous intensity aerobic exercise
Interventions
Aerobic exercise at 50% peak oxygen consumption for the number of weekly minutes prescribed in the original STRRIDE trial
Aerobic exercise at 50% peak oxygen consumption for the number of weekly minutes prescribed in the original STRRIDE trial
Aerobic exercise at 75% peak oxygen consumption for the number of weekly minutes prescribed in the original STRRIDE trial
Eligibility Criteria
You may qualify if:
- Individuals who completed participation in the STRRIDE-PD trial (NCT00962962)
- Body Mass Index (BMI) \> 18 and \< 45 kg/m2
- Stable dose (≥1 month) of any cardiometabolic medications
You may not qualify if:
- Poor vein access
- Current use of tobacco or any nicotine products, including e-cigarettes
- Insulin-dependent diabetes
- Active untreated hypothyroidism with thyroid stimulating hormone (TSH) concentrations \> 10.0 uIU/mL
- Systemic inflammatory or connective tissue disease, chronic infectious disease, chronic pulmonary disease or symptomatic cardiovascular disease with positive functional study by ECG or imaging
- Current, actively treated malignancy other than dermatologic conditions
- Absolute contraindications to exercise testing: ongoing unstable angina; uncontrolled cardiac arrhythmia with hemodynamic compromise; active endocarditis; symptomatic severe aortic stenosis; decompensated heart failure; acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis; acute myocarditis or pericarditis; acute aortic dissection; physical disability that precludes safe and adequate testing
- Relative contraindications to exercise testing: known obstructive left main coronary artery stenosis; moderate to severe aortic stenosis with uncertain relation to symptoms; tachyarrhythmias with uncontrolled ventricular rates; acquired advanced or complete heart block; hypertrophic obstructive cardiomyopathy with severe resting gradient; recent stroke or transient ischemic attack; mental impairment with limited ability to cooperate; uncorrected medical conditions, such as hypertension, significant anemia, important electrolyte imbalance, and hyperthyroidism
- Modified testing contraindications: acute myocardial infarction (MI) within six months; resting hypertension with systolic or diastolic blood pressures \>160/90 mmHg
- Unable to safely participate in an exercise program per study protocol per PI discretion
- Planned, intentional weight loss during study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- National Institutes of Health (NIH)collaborator
- National Institute on Aging (NIA)collaborator
Study Sites (1)
Duke Center for Living
Durham, North Carolina, 27705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leanna M Ross, PhD
Duke University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2024
First Posted
June 24, 2024
Study Start
April 2, 2025
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
November 14, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share