Role of Aging and Individual Variation in Exercise Training Responsiveness (STRRIDE IV)

May 19, 2026 updated by: Duke University

The 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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke Center for Living

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Amount/Moderate Intensity (Low/Mod)
Six months of low amount/moderate intensity aerobic exercise
Behavioral: Low/Mod
Aerobic exercise at 50% peak oxygen consumption for the number of weekly minutes prescribed in the original STRRIDE trial
Experimental: High Amount/Moderate Intensity (High/Mod)
Six months of high amount/moderate intensity aerobic exercise
Behavioral: High/Mod
Aerobic exercise at 50% peak oxygen consumption for the number of weekly minutes prescribed in the original STRRIDE trial
Experimental: High Amount/Vigorous Intensity (High/Vig)
Six months of high amount/vigorous intensity aerobic exercise
Behavioral: High/Vig
Aerobic exercise at 75% peak oxygen consumption for the number of weekly minutes prescribed in the original STRRIDE trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, early-intervention (~6 weeks), and post-intervention (~24 weeks)
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
Baseline, early-intervention (~6 weeks), and post-intervention (~24 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Composition
Time Frame: Baseline and post-intervention (~24 weeks)
Body composition will be assessed as percent fat mass and percent fat-free mass.
Baseline and post-intervention (~24 weeks)
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.
Baseline, early-intervention (~6 weeks), mid-intervention (~12 weeks), and post-intervention (~24 weeks)
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.
Baseline, early-intervention (~6 weeks), mid-intervention (~12 weeks), and post-intervention (~24 weeks)
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.
Baseline, early-intervention (~6 weeks), mid-intervention (~12 weeks), and post-intervention (~24 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

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

Investigators

  • Principal Investigator: Leanna M Ross, PhD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

June 21, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00115833
  • 5P30AG028716-18 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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