NCT06940037 · Mayo Clinic
The Impact of Biological Mechanisms of Aging on Response Variability to Resistance Training in Older Adults
(BRIO)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Progressive Resistance Training
3 times a week
OTHER
Health Education
once a week
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Boston, Massachusetts
- Rochester, Minnesota
Collaborators
National Institute on Aging (NIA), Tufts University Jean Mayer USDA Human Nutrition Research Center on Aging
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 16, 2025 · Source of record for eligibility and locations