The Impact of Biological Mechanisms of Aging on Response Variability to Resistance Training in Older Adults (BRIO)

September 30, 2026 updated by: Nathan K. LeBrasseur, Mayo Clinic

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University
        • Principal Investigator:
          • Roger Fielding, PhD
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Nathan LeBrasseur, Ph.D, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Progressive Resistance Training

participants will attend exercise session 3 times per week.
Other: Progressive Resistance Training

3 times a week
Other: Health Education

participants will attend health educations classed 1 time per week.
Other: Health Education

once a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 6 months
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.
baseline, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Precisely define the variability in changes in skeletal muscle size.
Time Frame: baseline, 6 months

Measured by computed tomography scans of the mid-thigh. Larger muscle cross-sectional area (cm^2) reflects a greater quantity of skeletal muscle.
baseline, 6 months
Precisely define the variability in changes in skeletal muscle strength.
Time Frame: baseline, 6 months

Measured by the one-repetition maximum, in newtons, on a leg press device, with higher scores reflecting greater skeletal muscle strength.
baseline, 6 months
Precisely define the variability in changes in six-minute walk distance.
Time Frame: baseline, 6 months

Measured by the distance (meters) walked in six minutes, with longer distances reflecting better physical function.
baseline, 6 months
Precisely define the variability in insulin secretion in response to a mixed meal tolerance test.
Time Frame: baseline, 6 months

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.
baseline, 6 months
Precisely define the variability in changes in the percentage of glycated hemoglobin in the blood.
Time Frame: baseline, 6 months

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.
baseline, 6 months
Precisely define the variability in changes in blood lipids.
Time Frame: baseline, 6 months

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.
baseline, 6 months
Precisely define the variability in changes in waist-to-hip ratio.
Time Frame: baseline, 6 months

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).
baseline, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Institute on Aging (NIA)
Tufts University Jean Mayer USDA Human Nutrition Research Center on Aging

Investigators

  • Principal Investigator: Nathan LeBrasseur, Ph.D, MS, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2025

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

August 31, 2030

Study Registration Dates

First Submitted

January 16, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 23, 2025

Study Record Updates

Last Update Posted (Actual)

October 5, 2026

Last Update Submitted That Met QC Criteria

September 30, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-010008
  • R01AG089150 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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