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NCT Number: NCT06940037

The Impact of Biological Mechanisms of Aging on Response Variability to 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.

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Key information

Conditions

Aging Behavior Mobility Disability Motor Activity

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progressive resistance training

Other

3 times a week

Health education

Other

once a week

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Tweed

CONTACT

[email protected]

507-255-6663

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

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

Registry information

Official study 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.

Acronym: BRIO

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Apr 23, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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