Prediabetic StateSTRRIDE IVNCT06471569
Role of Aging and Individual Variation in Exercise Training Responsiveness
A study testing Low/Mod, High/Mod and High/Vig in people with Prediabetic State and Cardiovascular Diseases, run by Duke University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Prediabetic State, Cardiovascular Diseases, Insulin Resistance
- What is being tested?
- Low/Mod, High/Mod and High/Vig
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2025to 29 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Duke Center for Living
Durham, North Carolina, 27705
About this study
Official title: The Role of Aging and Individual Variation in Exercise Training Responsiveness
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.
- Being tested
- Low/Mod, High/Mod, High/Vig
- Keywords
- Exercise, Cardiorespiratory Fitness, Functional Capacity, Cardiometabolic Risk, Physical Reserve, Physical Resilience
- Medical subject headings
- Prediabetic State, Cardiovascular Diseases, Insulin Resistance, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low/ModBehavioural
Aerobic exercise at 50% peak oxygen consumption for the number of weekly minutes prescribed in the original STRRIDE trial
High/ModBehavioural
Aerobic exercise at 50% peak oxygen consumption for the number of weekly minutes prescribed in the original STRRIDE trial
High/VigBehavioural
Aerobic exercise at 75% peak oxygen consumption for the number of weekly minutes prescribed in the original STRRIDE trial
| Study group | Role | What they receive |
|---|---|---|
| Low Amount/Moderate Intensity (Low/Mod) | Experimental | Six months of low amount/moderate intensity aerobic exercise Receives: Behavioral: Low/Mod |
| High Amount/Moderate Intensity (High/Mod) | Experimental | Six months of high amount/moderate intensity aerobic exercise Receives: Behavioral: High/Mod |
| High Amount/Vigorous Intensity (High/Vig) | Experimental | Six months of high amount/vigorous intensity aerobic exercise Receives: Behavioral: High/Vig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
Insulin sensitivity will be measured with a 2-hour oral glucose tolerance test
Measured: Baseline, early-intervention (~6 weeks), and post-intervention (~24 weeks)
Cardiorespiratory Fitness
Cardiorespiratory fitness will be measured with a maximal cardiopulmonary exercise test
Measured: Baseline, early-intervention (~6 weeks), and post-intervention (~24 weeks)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, early-intervention (~6 weeks), mid-intervention (~12 weeks), and post-intervention (~24 weeks)
Body Composition
Body composition will be assessed as percent fat mass and percent fat-free mass.
Measured: Baseline and post-intervention (~24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start2 Apr 2025
- Primary completion29 May 2026
- Study completion29 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Leanna M Ross, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471569
- Sponsor's protocol ID
- Pro00115833
- Other IDs
- 5P30AG028716-18
- Acronym
- STRRIDE IV
- Status last verified
- Jul 2026
- First submitted
- 10 Jun 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Aging and Individual Variation in Exercise Training Responsiveness
- ClinicalTrials.gov ID
- NCT06471569
- Acronym / sponsor ID
- STRRIDE IV / Pro00115833
- Keywords
- Exercise, Cardiorespiratory Fitness, Functional Capacity, Cardiometabolic Risk, Physical Reserve, Physical Resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Amount/Moderate Intensity (Low/Mod) | Experimental | Behavioral: Low/ModSix months of low amount/moderate intensity aerobic exercise |
| High Amount/Moderate Intensity (High/Mod) | Experimental | Behavioral: High/ModSix months of high amount/moderate intensity aerobic exercise |
| High Amount/Vigorous Intensity (High/Vig) | Experimental | Behavioral: High/VigSix months of high amount/vigorous intensity aerobic exercise |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low/ModAerobic exercise at 50% peak oxygen consumption for the number of weekly minutes prescribed in the original STRRIDE trial | Behavioural | Low Amount/Moderate Intensity (Low/Mod) |
| High/ModAerobic exercise at 50% peak oxygen consumption for the number of weekly minutes prescribed in the original STRRIDE trial | Behavioural | High Amount/Moderate Intensity (High/Mod) |
| High/VigAerobic exercise at 75% peak oxygen consumption for the number of weekly minutes prescribed in the original STRRIDE trial | Behavioural | High Amount/Vigorous Intensity (High/Vig) |
Primary outcome
Insulin Sensitivity
Time frame: Baseline, early-intervention (~6 weeks), and post-intervention (~24 weeks)
Insulin sensitivity will be measured with a 2-hour oral glucose tolerance test
Cardiorespiratory Fitness
Time frame: Baseline, early-intervention (~6 weeks), and post-intervention (~24 weeks)
Cardiorespiratory fitness will be measured with a maximal cardiopulmonary exercise test
4 secondary outcomes
Perceived Global Health
Time frame: Baseline, early-intervention (~6 weeks), mid-intervention (~12 weeks), and post-intervention (~24 weeks)
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
Time frame: Baseline, early-intervention (~6 weeks), mid-intervention (~12 weeks), and post-intervention (~24 weeks)
Body Composition
Time frame: Baseline and post-intervention (~24 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leanna M Ross, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low/Mod, High/Mod and High/Vig in people with Prediabetic State and Cardiovascular Diseases, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Sensitivity (time frame: Baseline, early-intervention (~6 weeks), and post-intervention (~24 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.