NCT03440099

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

June 28, 2022

Status Verified

May 1, 2022

Enrollment Period

6.2 years

First QC Date

January 12, 2018

Last Update Submit

June 21, 2022

Conditions

Keywords

Resistance TrainingSex Differences

Outcome Measures

Primary Outcomes (3)

  • Change in peak isokinetic power

    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

    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

    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.

Study Arms (1)

Training

OTHER

All participants will participate in the 16-week resistance exercise training program.

Other: Resistance exercise training

Interventions

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.

Training

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts

Amherst, Massachusetts, 01003, United States

RECRUITING

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mark S Miller, PhD

    University of Massachusetts, Amherst

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark S Miller, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2018

First Posted

February 20, 2018

Study Start

January 1, 2018

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

June 28, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

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.

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

Locations