RECRUITING

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

Conditions

Aging Mobility Disability mobility exercise senescence DNA methylation skeletal muscle

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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.

Quick Facts

Study Start:2025-08-11

Study Completion:2030-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06940037

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Amanda Tweed

CONTACT

507-255-6663

tweed.amanda@mayo.edu

Principal Investigator

Nathan LeBrasseur, Ph.D, MS

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University

Boston, Massachusetts, 02111

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Nathan LeBrasseur, Ph.D, MS, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-11

Study Completion Date2030-08-31

Study Record Updates

Study Start Date2025-08-11

Study Completion Date2030-08-31

Terms related to this study

Keywords Provided by Researchers

aging
mobility
exercise
senescence
DNA methylation
skeletal muscle

Additional Relevant MeSH Terms

Aging
Mobility Disability