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Recruiting NCT06940037

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

No phase Interventional Aging Mobility Disability

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Progressive Resistance Training, Health Education.
Who it may be relevant to
Registry conditions: Aging, Mobility Disability. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

Overview

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]
  • Precisely define the variability in changes in blood glucose concentrations in response to a meal tolerance test [Time frame: baseline, 6 months]
Secondary outcome measures (7)
  • Precisely define the variability in changes in skeletal muscle size. [Time frame: baseline, 6 months]
  • Precisely define the variability in changes in skeletal muscle strength. [Time frame: baseline, 6 months]
  • Precisely define the variability in changes in six-minute walk distance. [Time frame: baseline, 6 months]
  • Precisely define the variability in insulin secretion in response to a mixed meal tolerance test. [Time frame: baseline, 6 months]
  • Precisely define the variability in changes in the percentage of glycated hemoglobin in the blood. [Time frame: baseline, 6 months]
  • Precisely define the variability in changes in blood lipids. [Time frame: baseline, 6 months]
  • Precisely define the variability in changes in waist-to-hip ratio. [Time frame: baseline, 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 2 centers
  • Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University — Boston
  • Mayo Clinic — Rochester

Identifiers

NCT: NCT06940037 · 24-010008 · R01AG089150

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗