Role of Aging and Individual Variation in Exercise Training Responsiveness

NCT ID: NCT06471569

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-02

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prediabetic State Cardiovascular Diseases Insulin Resistance Obesity

Keywords

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Exercise Cardiorespiratory Fitness Functional Capacity Cardiometabolic Risk Physical Reserve Physical Resilience

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Low Amount/Moderate Intensity (Low/Mod)

Six months of low amount/moderate intensity aerobic exercise

Group Type EXPERIMENTAL

Low/Mod

Intervention Type BEHAVIORAL

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)

Six months of high amount/moderate intensity aerobic exercise

Group Type EXPERIMENTAL

High/Mod

Intervention Type BEHAVIORAL

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

High Amount/Vigorous Intensity (High/Vig)

Six months of high amount/vigorous intensity aerobic exercise

Group Type EXPERIMENTAL

High/Vig

Intervention Type BEHAVIORAL

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

Interventions

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Low/Mod

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

Intervention Type BEHAVIORAL

High/Mod

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

Intervention Type BEHAVIORAL

High/Vig

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leanna M Ross, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke Center for Living

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Johanna L Johnson, MS

Role: CONTACT

Phone: 9196606766

Email: [email protected]

Leanna M Ross, PhD

Role: CONTACT

Phone: 9196606688

Email: [email protected]

Facility Contacts

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Alyssa Sudnick, MS

Role: primary

Other Identifiers

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5P30AG028716-18

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00115833

Identifier Type: -

Identifier Source: org_study_id