Recruiting

Exercise Response Heterogeneity

Sponsor:

Mayo Clinic

Code:

NCT06940037

Conditions

Aging

Mobility Disability

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

Progressive Resistance Training

Health Education

Study Details

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.

Conditions

Aging

Mobility Disability

Study ID

NCT06940037

Start date

Aug 11, 2025

Status verified date

Aug, 2025

Completion date

Aug 31, 2030

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Progressive Resistance Training

participants will attend exercise session 3 times per week.

other: Health Education

participants will attend health educations classed 1 time per week.

Interventions

Progressive Resistance Training

3 times a week

Health Education

once a week

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Amanda Tweed

507-255-6663tweed.amanda@mayo.edu

Locations

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

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Arion Mete

617-556-3237arion.mete@tufts.edu

Principal Investigator:

Roger Fielding, PhD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Amanda Tweed

507-255-6663tweed.amanda@mayo.edu

Principal Investigator:

Nathan LeBrasseur, Ph.D, MS

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 16, 2025

Last verified

Aug, 2025

Keywords

  • aging
  • mobility
  • exercise
  • senescence
  • DNA methylation
  • skeletal muscle

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-09-16.