Clinical trial NCT06940037: The Impact of Biological Mechanisms of Aging on Response Variability to Resistance Training in Older Adults
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aging
Mobility Disability
Keywords: aging
mobility
exercise
senescence
DNA methylation
skeletal muscle
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Tufts University Jean Mayer USDA Human Nutrition Research Center on Aging
First posted: 2025-04-23
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Progressive Resistance Training vs. Health Education
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Precisely define the variability in changes in physical function
timeFrame: baseline, 6 months
measure: Precisely define the variability in changes in blood glucose concentrations in response to a meal tolerance test
timeFrame: baseline, 6 months
Secondary outcomes:
measure: Precisely define the variability in changes in skeletal muscle size.
timeFrame: baseline, 6 months
measure: Precisely define the variability in changes in skeletal muscle strength.
timeFrame: baseline, 6 months
measure: Precisely define the variability in changes in six-minute walk distance.
timeFrame: baseline, 6 months
measure: Precisely define the variability in insulin secretion in response to a mixed meal tolerance test.
timeFrame: baseline, 6 months
measure: Precisely define the variability in changes in the percentage of glycated hemoglobin in the blood.
timeFrame: baseline, 6 months
measure: Precisely define the variability in changes in blood lipids.
timeFrame: baseline, 6 months
measure: Precisely define the variability in changes in waist-to-hip ratio.
timeFrame: baseline, 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Nathan LeBrasseur, Ph.D, MS
role: PRINCIPAL_INVESTIGATOR
References: