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

NCT ID: NCT06940037

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-11

Study Completion Date

2030-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aging Mobility Disability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Progressive Resistance Training vs. Health Education
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Data analysis team

Study Groups

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Progressive Resistance Training

participants will attend exercise session 3 times per week.

Group Type OTHER

Progressive Resistance Training

Intervention Type OTHER

3 times a week

Health Education

participants will attend health educations classed 1 time per week.

Group Type OTHER

Health Education

Intervention Type OTHER

once a week

Interventions

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Progressive Resistance Training

3 times a week

Intervention Type OTHER

Health Education

once a week

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Tufts University Jean Mayer USDA Human Nutrition Research Center on Aging

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Nathan K. LeBrasseur

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nathan LeBrasseur, Ph.D, MS

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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

Boston, Massachusetts, United States

Site Status RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amanda Tweed

Role: CONTACT

507-255-6663

Facility Contacts

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Arion Mete

Role: primary

617-556-3237

Amanda Tweed

Role: primary

507-255-6663

Other Identifiers

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R01AG089150

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-010008

Identifier Type: -

Identifier Source: org_study_id

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