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

Duke University

Status: Enrolling

Conditions: Prediabetic State; Insulin Resistance; Obesity; Cardiovascular Diseases

Treatments: Behavioral: Low/Mod; Behavioral: High/Vig; Behavioral: High/Mod

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06471569

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

Pro00115833

Details and patient eligibility

About

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.

Enrollment: 26 estimated patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

26 participants in 3 patient groups

Low Amount/Moderate Intensity (Low/Mod)

Experimental group

Description:

Six months of low amount/moderate intensity aerobic exercise

Treatment:

Behavioral: Low/Mod

High Amount/Moderate Intensity (High/Mod)

Experimental group

Description:

Six months of high amount/moderate intensity aerobic exercise

Treatment:

Behavioral: High/Mod

High Amount/Vigorous Intensity (High/Vig)

Experimental group

Description:

Six months of high amount/vigorous intensity aerobic exercise

Treatment:

Behavioral: High/Vig