AgingBRIONCT06940037
The Impact of Biological Mechanisms of Aging on Response Variability to Resistance Training in Older Adults
A study testing Progressive Resistance Training and Health Education in people with Aging and Mobility Disability, run by Mayo Clinic at 2 sites in United States.
Trial summary
To critically examine biological, clinical, and behavioral modulators of progressive resistance training-associated exercise response heterogeneity in physical function and whole-body metabolism in older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Mobility Disability
- What is being tested?
- Progressive Resistance Training and Health Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Aug 2025to 31 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- aged greater than or equal to 65 years
- sedentary (Community Healthy Activities Model Program for Seniors physical activity questionnaire to identify and exclude persons engaged in regular (125 min/week or more) moderate intensity physical activity
- at risk for mobility disability score of less than or equal to 10 (but greater than 3) on the SPPB
- willing to be randomized into HE or PRT
- willing to be transported or transport themselves to the clinical sites for the intervention and assessments
Who cannot join
- unwillingness to provide informed consent
- participation in lifestyle or pharmacologic intervention trial or structured program of exercise training in the past 6 months
- an SPPB score of less than or equal to 3
- osteoarthritis or condition with joint pain limiting daily life activities
- significant weight loss or gain (7.5% of body weight) in past six months
- current anti-coagulant or anti-platelet therapy (Coumadin, Eliquis, Pradaxa, Xarelto, heparin, Lovenox, Plavix)
Show all 26Show fewer
- clinically significant abnormality in any of the screening laboratory values, including those identified as outside of the "normal limits', that are deemed to be of concern for participation in the study by the study physician
- acute or terminal illness
- Mini Mental State Exam (MMSE) <23
- myocardial infarction in the previous 6 months or other symptomatic coronary artery disease
- New York Heart Association Class III or IV congestive heart failure
- serious conduction disorder (e.g., 3rd degree heart block), uncontrolled arrhythmia, or new Q waves or ST-segment depressions (>3 mm) on ECG
- chronic obstructive pulmonary disease requiring oxygen therapy
- upper or lower extremity fracture in the previous 6 months
- uncontrolled hypertension (150/90 mm Hg)
- neuromuscular diseases and/or drugs which affect neuromuscular function
- current use of anabolic steroids, growth hormone, replacement androgen therapy, anti-androgen therapy
- allergy to lidocaine
- presence of significant liver or renal disease (eGFR < 45 mL/min)
- diagnosis of type I diabetes mellitus or insulin requiring type 2 diabetes mellitus
- HbA1c > 7%
- BMI <21 or >35 for men or >40 for women
- excessive alcohol intake (>14 alcoholic beverages per wk.)
- current tobacco use
- current participation in any interventional clinical trial
- current use of weight loss medications
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University
Boston, Massachusetts, 02111
Arion Mete, 617-556-3237, arion.mete@tufts.edu
Roger Fielding, PhD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Amanda Tweed, 507-255-6663, tweed.amanda@mayo.edu
Nathan LeBrasseur, Ph.D, MS
About this study
Official title: The Impact of Biological Mechanisms of Aging on Response Variability to Resistance Training in Older Adults (BRIO): A Randomized, Placebo-controlled Trial of Progressive Resistance Training in Older Adults.
To critically examine biological, clinical, and behavioral modulators of progressive resistance training-associated exercise response heterogeneity in physical function and whole-body metabolism in older adults.
Read the detailed description
A 6-month, single blind, randomized, controlled multi-center clinical trial comparing a Health Education control intervention to a supervised Progressive Resistance Training intervention to test the central hypothesis that biological mechanisms of aging are mediators of exercise response heterogeneity in older adults.
- Conditions
- Aging, Mobility Disability
- Being tested
- Progressive Resistance Training, Health Education
- Keywords
- aging, mobility, exercise, senescence, DNA methylation, skeletal muscle
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Resistance TrainingOther
3 times a week
Health EducationOther
once a week
| Study group | Role | What they receive |
|---|---|---|
| Progressive Resistance Training | Other | participants will attend exercise session 3 times per week. Receives: Other: Progressive Resistance Training |
| Health Education | Other | participants will attend health educations classed 1 time per week. Receives: Other: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precisely define the variability in changes in physical function
Measured by the Short Physical Performance Battery (SPPB), a 0-12 categorical scale of walking speed, standing balance, and repeated sit-to-stand time, with higher scores reflecting better physical function.
Measured: baseline, 6 months
Precisely define the variability in changes in blood glucose concentrations in response to a meal tolerance test
Blood glucose concentrations (millimoles/liter) will be measured in response to a physiologically relevant meal challenge. Lower values are indicative of better metabolic health.
Measured: baseline, 6 months
Secondary outcomes (7)
Precisely define the variability in changes in skeletal muscle size.
Measured by computed tomography scans of the mid-thigh. Larger muscle cross-sectional area (cm^2) reflects a greater quantity of skeletal muscle.
Measured: baseline, 6 months
Precisely define the variability in changes in skeletal muscle strength.
Measured by the one-repetition maximum, in newtons, on a leg press device, with higher scores reflecting greater skeletal muscle strength.
Measured: baseline, 6 months
Precisely define the variability in changes in six-minute walk distance.
Measured by the distance (meters) walked in six minutes, with longer distances reflecting better physical function.
Measured: baseline, 6 months
Precisely define the variability in insulin secretion in response to a mixed meal tolerance test.
Blood insulin concentrations (pmol/L) will be measured in response to a physiologically relevant meal challenge. Insulin concentrations in a physiological range reflect better metabolic health, while low insulin concentrations can reflect an impaired insulin response and high insulin concentrations can reflect peripheral insulin resistance.
Measured: baseline, 6 months
Precisely define the variability in changes in the percentage of glycated hemoglobin in the blood.
Measured by the percentage of glycated hemoglobin in the blood (often referred to as HbA1c). A lower percentage of HbAlc reflects lower blood glucose concentrations over the past two to three months.
Measured: baseline, 6 months
Precisely define the variability in changes in blood lipids.
Blood lipids, including total cholesterol, low density lipoproteins (LDLs), high density lipoproteins (HDLs), and triglycerides will be measured. Lower levels of total cholesterol (mg/dL), LDLs (mg/dL), and triglycerides (mg/dL), and higher levels of HDLs (mg/dL), are reflective of better metabolic health.
Measured: baseline, 6 months
Precisely define the variability in changes in waist-to-hip ratio.
The circumference (cm) of the waist and hips will be measured and a ratio will be calculated. A lower waist-to-hip ratio is reflective of a better body composition (less central obesity or visceral fat).
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start11 Aug 2025
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Progressive Resistance Training vs. Health Education
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Tufts University Jean Mayer USDA Human Nutrition Research Center on Aging
- Responsible party
- Principal investigator, Nathan K. LeBrasseur, Mayo Clinic
- Investigators
- Nathan LeBrasseur, Ph.D, MS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940037
- Sponsor's protocol ID
- 24-010008
- Other IDs
- R01AG089150
- Acronym
- BRIO
- Status last verified
- Sep 2026
- First submitted
- 16 Jan 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Biological Mechanisms of Aging on Response Variability to Resistance Training in Older Adults (BRIO): A Randomized, Placebo-controlled Trial of Progressive Resistance Training in Older Adults.
- ClinicalTrials.gov ID
- NCT06940037
- Acronym / sponsor ID
- BRIO / 24-010008
- Conditions
- Aging, Mobility Disability
- Keywords
- aging, mobility, exercise, senescence, DNA methylation, skeletal muscle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Tufts University Jean Mayer USDA Human Nutrition Research Center on Aging
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 23 Apr 2025 (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.
To critically examine biological, clinical, and behavioral modulators of progressive resistance training-associated exercise response heterogeneity in physical function and whole-body metabolism in older adults.
Detailed description
A 6-month, single blind, randomized, controlled multi-center clinical trial comparing a Health Education control intervention to a supervised Progressive Resistance Training intervention to test the central hypothesis that biological mechanisms of aging are mediators of exercise response heterogeneity in older adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Progressive Resistance Training vs. Health Education
| Arm | Type | Receives |
|---|---|---|
| Progressive Resistance Training | Other | Other: Progressive Resistance Trainingparticipants will attend exercise session 3 times per week. |
| Health Education | Other | Other: Health Educationparticipants will attend health educations classed 1 time per week. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- aged greater than or equal to 65 years
- sedentary (Community Healthy Activities Model Program for Seniors physical activity questionnaire to identify and exclude persons engaged in regular (125 min/week or more) moderate intensity physical activity
- at risk for mobility disability score of less than or equal to 10 (but greater than 3) on the SPPB
- willing to be randomized into HE or PRT
- willing to be transported or transport themselves to the clinical sites for the intervention and assessments
Key exclusion criteria (26 listed)
- unwillingness to provide informed consent
- participation in lifestyle or pharmacologic intervention trial or structured program of exercise training in the past 6 months
- an SPPB score of less than or equal to 3
- osteoarthritis or condition with joint pain limiting daily life activities
- significant weight loss or gain (7.5% of body weight) in past six months
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 |
|---|---|---|
| Progressive Resistance Training3 times a week | Other | Progressive Resistance Training |
| Health Educationonce a week | Other | Health Education |
Primary outcome
Precisely define the variability in changes in physical function
Time frame: baseline, 6 months
Measured by the Short Physical Performance Battery (SPPB), a 0-12 categorical scale of walking speed, standing balance, and repeated sit-to-stand time, with higher scores reflecting better physical function.
Precisely define the variability in changes in blood glucose concentrations in response to a meal tolerance test
Time frame: baseline, 6 months
Blood glucose concentrations (millimoles/liter) will be measured in response to a physiologically relevant meal challenge. Lower values are indicative of better metabolic health.
7 secondary outcomes
Precisely define the variability in changes in skeletal muscle size.
Time frame: baseline, 6 months
Precisely define the variability in changes in skeletal muscle strength.
Time frame: baseline, 6 months
Precisely define the variability in changes in six-minute walk distance.
Time frame: baseline, 6 months
Precisely define the variability in insulin secretion in response to a mixed meal tolerance test.
Time frame: baseline, 6 months
Precisely define the variability in changes in the percentage of glycated hemoglobin in the blood.
Time frame: baseline, 6 months
Precisely define the variability in changes in blood lipids.
Time frame: baseline, 6 months
Precisely define the variability in changes in waist-to-hip ratio.
Time frame: baseline, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 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.
Nathan LeBrasseur, Ph.D, MS principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Resistance Training and Health Education in people with Aging and Mobility Disability, run by Mayo Clinic at 2 sites 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 5 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Tweed (507-255-6663, tweed.amanda@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Precisely define the variability in changes in physical function (time frame: baseline, 6 months). 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 5 Oct 2026.