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Completed

NCT Number: NCT06471569

Role of Aging and Individual Variation in Exercise Training Responsiveness

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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Key information

Conditions

Prediabetic State Behavior Body Weight Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Center for Living

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Low/Mod

Behavioral

Aerobic exercise at 50% peak oxygen consumption for the number of weekly minutes prescribed in the original STRRIDE trial

High/Mod

Behavioral

Aerobic exercise at 50% peak oxygen consumption for the number of weekly minutes prescribed in the original STRRIDE trial

High/Vig

Behavioral

Aerobic exercise at 75% peak oxygen consumption for the number of weekly minutes prescribed in the original STRRIDE trial

Primary outcomes

  1. Insulin Sensitivity

    Time frame: Baseline, early-intervention (~6 weeks), and post-intervention (~24 weeks)

    Insulin sensitivity will be measured with a 2-hour oral glucose tolerance test

  2. Cardiorespiratory Fitness

    Time frame: Baseline, early-intervention (~6 weeks), and post-intervention (~24 weeks)

    Cardiorespiratory fitness will be measured with a maximal cardiopulmonary exercise test

Secondary outcomes

  1. Perceived Global Health

    Time frame: Baseline, early-intervention (~6 weeks), mid-intervention (~12 weeks), and post-intervention (~24 weeks)

    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.

  2. Health-Related Quality of Life

    Time frame: Baseline, early-intervention (~6 weeks), mid-intervention (~12 weeks), and post-intervention (~24 weeks)

    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.

  3. Metabolic Syndrome Z-Score

    Time frame: Baseline, early-intervention (~6 weeks), mid-intervention (~12 weeks), and post-intervention (~24 weeks)

    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.

  4. Body Composition

    Time frame: Baseline and post-intervention (~24 weeks)

    Body composition will be assessed as percent fat mass and percent fat-free mass.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Aging (NIA)
  • National Institutes of Health (NIH)

Registry information

Official study title

The Role of Aging and Individual Variation in Exercise Training Responsiveness

Acronym: STRRIDE IV

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2024
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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