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

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: Aging; Mobility Disability
• Intervention / Treatment: Other: Progressive Resistance Training; Other: Health Education

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amanda Tweed; Phone Number: 507-255-6663; Email: tweed.amanda@mayo.edu

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: Arion Mete; Phone Number: 617-556-3237; Email: arion.mete@tufts.edu
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Amanda Tweed; Phone Number: 507-255-6663; Email: tweed.amanda@mayo.edu
      • Principal Investigator: Nathan LeBrasseur, Ph.D, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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.	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.	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.	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.	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.	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.	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.	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

• 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

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 (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: exercise; aging; mobility; DNA methylation; skeletal muscle; senescence
• Additional Relevant MeSH Terms: Behavior; Motor Activity
• 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
• product manufactured in and exported from the U.S.: No