Role of Aging and Individual Variation in Exercise Training Responsiveness

Duke University9 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Prediabetic State Cardiovascular Diseases Insulin Resistance Obesity

Interventions

Low/ModBEHAVIORAL

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

High/ModBEHAVIORAL

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

High/VigBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 60 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke Center for Living

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Insulin Sensitivity

Insulin sensitivity will be measured with a 2-hour oral glucose tolerance test

Time frame: Baseline, early-intervention (~6 weeks), and post-intervention (~24 weeks)

Cardiorespiratory Fitness

Cardiorespiratory fitness will be measured with a maximal cardiopulmonary exercise test

Time frame: Baseline, early-intervention (~6 weeks), and post-intervention (~24 weeks)

Secondary Outcomes

Perceived Global Health

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.

Time frame: Baseline, early-intervention (~6 weeks), mid-intervention (~12 weeks), and post-intervention (~24 weeks)

Health-Related Quality of Life

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.

Time frame: Baseline, early-intervention (~6 weeks), mid-intervention (~12 weeks), and post-intervention (~24 weeks)

Metabolic Syndrome Z-Score

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.

Data from ClinicalTrials.gov

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