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

NCT06940037 | Recruiting DMC

• 2 other identifiers: 24-010008R01AG089150
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Precisely define the variability in changes in physical function

  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.

  baseline, 6 months

• Precisely define the variability in changes in blood glucose concentrations in response to a meal tolerance test

  Blood glucose concentrations (millimoles/liter) will be measured in response to a physiologically relevant meal challenge. Lower values are indicative of better metabolic health.

  baseline, 6 months

Secondary Outcomes (7)

• Precisely define the variability in changes in skeletal muscle size.

  baseline, 6 months

• Precisely define the variability in changes in skeletal muscle strength.

  baseline, 6 months

• Precisely define the variability in changes in six-minute walk distance.

  baseline, 6 months

• Precisely define the variability in insulin secretion in response to a mixed meal tolerance test.

  baseline, 6 months

• Precisely define the variability in changes in the percentage of glycated hemoglobin in the blood.

  baseline, 6 months

Study Arms (2)

Progressive Resistance Training

OTHER

participants will attend exercise session 3 times per week.

Other: Progressive Resistance Training

Health Education

OTHER

participants will attend health educations classed 1 time per week.

Other: Health Education

Interventions

Progressive Resistance Training OTHER

3 times a week

Progressive Resistance Training

Health Education OTHER

once a week

Health Education

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute on Aging (NIA): collaborator
• Tufts University Jean Mayer USDA Human Nutrition Research Center on Aging: collaborator

Study Sites (2)

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

Boston, Massachusetts, 02111, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Nathan LeBrasseur, Ph.D, MS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Tweed

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data analysis team
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Progressive Resistance Training vs. Health Education

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: April 23, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2030
• Last Updated: September 16, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)