NCT06471569

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Apr 2025Mar 2027

First Submitted

Initial submission to the registry

June 10, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

April 2, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

November 14, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

June 10, 2024

Last Update Submit

November 12, 2025

Conditions

Keywords

ExerciseCardiorespiratory FitnessFunctional CapacityCardiometabolic RiskPhysical ReservePhysical Resilience

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)

EXPERIMENTAL

Six months of low amount/moderate intensity aerobic exercise

Behavioral: Low/Mod

High Amount/Moderate Intensity (High/Mod)

EXPERIMENTAL

Six months of high amount/moderate intensity aerobic exercise

Behavioral: High/Mod

High Amount/Vigorous Intensity (High/Vig)

EXPERIMENTAL

Six months of high amount/vigorous intensity aerobic exercise

Behavioral: High/Vig

Interventions

Low/ModBEHAVIORAL

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

Low Amount/Moderate Intensity (Low/Mod)
High/ModBEHAVIORAL

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

High Amount/Moderate Intensity (High/Mod)
High/VigBEHAVIORAL

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

High Amount/Vigorous Intensity (High/Vig)

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Duke Center for Living

Durham, North Carolina, 27705, United States

RECRUITING

MeSH Terms

Conditions

Prediabetic StateCardiovascular DiseasesInsulin ResistanceObesityMotor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Leanna M Ross, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna L Johnson, MS

CONTACT

Leanna M Ross, PhD

CONTACT

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

Locations