Sex-specific Adaptation to Resistance Training in Older Adults

June 21, 2022 updated by: University of Massachusetts, Amherst

Sex-specific Adaptation to Different Resistance Exercise Programs in Older Adults

In general, men and women experience differing degrees of age-related decreases in physical function, with women having a greater prevalence of functional limitations and disability. A key predictor of this decrease in functional capacity is the reduction in leg muscle maximal power (product of force and velocity), which can be improved with exercise training. However, the development of exercise interventions to optimally improve skeletal muscle function in older adults has been difficult, in part because we now know that men and women respond differently to the same exercise training stimulus. In fact, the fundamental mechanisms by which habitual exercise improves physical function in older adults are still not well understood. The proposed studies are designed to address these knowledge gaps by examining the molecular and cellular mechanisms underlying the response to two distinct exercise training paradigms, and determining how these responses differ between older men and women. The investigators hypothesize that molecular, cellular and whole muscle contractile performance will be most improved in men by traditional low-velocity, high-load resistance training, and in women by high-velocity, low-load power training. Moreover, sex-specific structural responses in myofilament remodeling, protein expression and post-translational modifications will explain these sex-specific performance adaptations to each modality. To test these hypotheses, data will be gathered from 50 healthy, sedentary older men and women (65-75 years) prior to and following a 16-week unilateral exercise training program in which one leg undergoes resistance training and the other power training. The Specific Aims of this project are to identify the sex-specific effects of low-velocity resistance training versus high-velocity power training on: Aim 1) skeletal muscle function at the molecular, cellular and whole muscle levels, and Aim 2) protein expression and modification as well as size at the molecular and cellular levels. The within subject, unilateral intervention design provides a powerful model to minimize the effects of between-subject variability, and the translational approach will take advantage of our unique expertise with state-of-the-art measures from the molecular to whole body levels.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Amherst, Massachusetts, United States, 01003
        • Recruiting
        • University of Massachusetts
        • Contact:

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 75 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Older adult (65-75 years old) volunteers will be healthy, by self-report, and sedentary, defined as no formal exercise program for the year prior to evaluation and < 2 sessions (30 min or more) of volitional exercise per week. Volunteers will be ambulatory without the use of walking aids and living independently in the community. All participants will be required to obtain a physician's consent to participate in the study, due to the exercise component, as is common practice in the Department of Kinesiology.

Exclusion Criteria:

  • History of major neurological or neuromuscular condition that may impact physical function, including cerebrovascular disease, peripheral neuropathy, neurodegenerative disease, demyelinating disease, cerebellar or extrapyramidal disease, etc.
  • History of myocardial infarction, angina, peripheral vascular disease, surgical or percutaneous coronary artery revascularization
  • History of severe pulmonary disease (i.e., dyspnea that limits activities of daily living such as household ambulation and self-care)
  • History of rheumatoid arthritis
  • History of diabetes or other metabolic disease that may impact neuromuscular function
  • Uncontrolled hypertension (blood pressure > 140/90)
  • History of smoking in the past 1 year
  • Moderate to severe lower extremity arthritis or pain (i.e., pain on level walking or that limits activities of daily living such as household ambulation and self-care)
  • Pain, muscle cramps, joint stiffness, dyspnea, angina, light-headedness or other symptoms upon exertion
  • The use of beta-blockers, sedatives, tranquilizers, or other medication that may impair physical function
  • Individuals taking statin medications who report symptoms of muscle pain or myopathy
  • Body-mass index >30 kg·m-2, as increased fat mass may alter single muscle fiber performance (Choi et al. J Gerontol A Biol Sci Med Sci 71:557-564, 2016)
  • Body-mass index <18 kg·m-2, as this may be an early sign of frailty
  • Must pass the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+, in Appendix)
  • Any persons taking anti-coagulant medication or with known coagulapathies will be excluded, due to increased bleeding risk from biopsy procedure
  • Participants with a contraindication for magnetic resonance testing, including a pace-maker or other implant
  • Women will be postmenopausal, as defined as cessation of menses for at least 12 months prior to study
  • Men and women undergoing hormone replacement therapy, because this treatment may circumvent normal age-related declines in sex hormone levels (if taken hormone therapy must have been > 5 years ago)
  • Unintentional weight loss of greater than 2.5 kg during the last 3 months
  • Currently participating in or have participated in a weight loss or exercise training program in the last year
  • An inability to understand written and spoken English
  • An inability to follow instructions, as determined by the investigators during the consenting process

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Training
All participants will participate in the 16-week resistance exercise training program.
Other: Resistance exercise training
16-week exercise training program, wherein one leg undergoes traditional low-velocity, high-load resistance training and the other leg undergoes high-velocity, low-load power training.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in peak isokinetic power
Time Frame: This measure will be collected for each volunteer pre- and post-16 week exercise intervention and take approximately 30 minutes to collect for each time point.
Peak isokinetic power at the whole muscle level will be evaluated using a dynamometer.
This measure will be collected for each volunteer pre- and post-16 week exercise intervention and take approximately 30 minutes to collect for each time point.
Change in single fiber specific power
Time Frame: This measure will be preformed on tissue biopsied from each volunteer pre- and post-16 week exercise intervention and requires approximately 1 week to collect per time point.
Single fiber specific power will be measured from segments of chemically-skinned single human skeletal muscle fibers under maximal calcium-activated conditions, with muscle fiber type determined post-measurement by gel electrophoresis
This measure will be preformed on tissue biopsied from each volunteer pre- and post-16 week exercise intervention and requires approximately 1 week to collect per time point.
Change in myosin attachment time
Time Frame: This measure will be preformed on tissue biopsied from each volunteer pre- and post-16 week exercise intervention and requires approximately one week to collect per time point.
Myosin attachment time will be measured from segments of chemically-skinned single human skeletal muscle fibers under maximal calcium-activated conditions, with muscle fiber type determined post-measurement by gel electrophoresis.
This measure will be preformed on tissue biopsied from each volunteer pre- and post-16 week exercise intervention and requires approximately one week to collect per time point.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Massachusetts, Amherst

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)
National Institute on Aging (NIA)
University of Vermont

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark S Miller, PhD, University of Massachusetts, Amherst

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 116-1974
  • 1R01AG047245-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Raw data will be considered for sharing under the rules indicated below. Raw datasets to be released for sharing will not contain identifiers. Data and associated documentation will be made available to users only under a signed and properly executed data-sharing agreement that provides for specific criteria under which the data will be used, including but not limited to a commitment to: 1) using the data only for research purposes; 2) securing the data using appropriate computer technology; and 3) destroying or returning the data after analyses are completed.

IPD Sharing Time Frame

Research data will be made available upon final acceptance for publication of the major findings from the proposed studies.

IPD Sharing Access Criteria

Data and associated documentation will be made available to users only under a signed and properly executed data-sharing agreement that provides for specific criteria under which the data will be used, including but not limited to a commitment to: 1) using the data only for research purposes; 2) securing the data using appropriate computer technology; and 3) destroying or returning the data after analyses are completed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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