Clinical trial NCT06471569: Role of Aging and Individual Variation in Exercise Training Responsiveness
Official title: The Role of Aging and Individual Variation in Exercise Training Responsiveness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prediabetic State
Cardiovascular Diseases
Insulin Resistance
Obesity
Keywords: Exercise
Cardiorespiratory Fitness
Functional Capacity
Cardiometabolic Risk
Physical Reserve
Physical Resilience
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2024-06-24
Enrollment: 8
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 8 participants to complete a 6-month aerobic exercise intervention.


Eligibility criteria: 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 hyper or hypothyroidism with thyroid stimulating hormone (TSH) concentrations \< 1.5 or \> 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

Primary outcomes:
measure: Insulin Sensitivity
timeFrame: Baseline, early-intervention (~6 weeks), and post-intervention (~24 weeks)
measure: Cardiorespiratory Fitness
timeFrame: Baseline, early-intervention (~6 weeks), and post-intervention (~24 weeks)
Secondary outcomes:
measure: Perceived Global Health
timeFrame: Baseline, early-intervention (~6 weeks), and post-intervention (~24 weeks)
measure: Health-Related Quality of Life
timeFrame: Baseline, early-intervention (~6 weeks), and post-intervention (~24 weeks)
measure: Metabolic Syndrome Z-Score
timeFrame: Baseline, early-intervention (~6 weeks), and post-intervention (~24 weeks)
measure: Body Composition
timeFrame: Baseline and post-intervention (~24 weeks)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Center for Living
state: North Carolina
Study officials:
affiliation: Duke University
name: Leanna M Ross, PhD
role: PRINCIPAL_INVESTIGATOR
References: