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CompletedNCT01190046Updated Nov 16, 2016

Chronic Muscle Disuse in the Elderly

An interventional study of Resistance exercise training in Osteoarthritis, sponsored by University of Vermont. Completed at 1 site in United States. Open to participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-16.

Sponsored by University of Vermont · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
60 Years to 80 Years
Sex
All
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Study summary

The purpose of this study is to define the effects of chronic disuse on skeletal muscle structure and function in elderly individuals at the cellular and molecular level by examining elderly characterized by chronic muscle disuse (patients with knee osteoarthritis) and healthy elderly no evidence of knee osteoarthritis and normal physical activity levels.

Read the detailed description

Skeletal muscle disuse is an important contributing factor to physical disability. Disuse is more frequent in the elderly and they are more susceptible to its debilitating effects because of their diminished physiological reserve. Despite these facts, the mechanisms whereby disuse promotes skeletal muscle contractile dysfunction in this population remain largely undetermined. Therefore, the investigators will systematically test for modifications of single skeletal muscle fiber structure and function that underlie contractile dysfunction. Elderly individuals characterized by chronic muscle disuse (patients with knee osteoarthritis) will be compared to carefully-matched controls with no clinical evidence of knee osteoarthritis and normal activity levels. Thereafter, elderly with chronic disuse will undergo an exercise intervention to remediate muscle disuse. The investigators hypothesize that muscle disuse impairs contractile function, in part, through alterations in myosin kinetics, myofilament protein content and the mechanical properties of the myofilament lattice and that exercise rehabilitation will counteract these deficits. The investigators will specifically examine the effect of disuse on mechanical, kinetic and structural properties and molecular composition of single muscle fibers in cases and controls, as well as determine how increasing muscle use in elderly with chronic disuse via exercise training affects muscle fiber mechanical, kinetic and structural properties and molecular composition. These translational studies will provide the first comprehensive evaluation of the cellular and molecular mechanisms through which muscle disuse alters skeletal muscle structure and contractile function in elderly humans. This knowledge can assist in the development and refinement of preventative and corrective therapies for disability by tailoring these approaches to address specific molecular defects.

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Conditions studied

  • Osteoarthritis

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Keywords

  • elderly
  • muscle
  • disuse
  • osteoarthritis
  • exercise
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 35 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

University of Vermont is the lead sponsor of 215 studies on the registry; 28 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

KNEE OSTEOARTHRITIS PATIENTS

Inclusion criteria

Inclusion Criteria:

  • 60-80 yrs of age
  • physician-diagnosed, symptomatic knee osteoarthritis
  • ambulatory and able to perform lower extremity resistance exercise

Exclusion criteria

Exclusion Criteria:

  • rheumatoid arthritis or other autoimmune disease
  • chronic heart, lung, kidney or liver disease or hypertension
  • diabetes
  • history of stroke
  • other neurological or musculoskeletal disease

HEALTHY CONTROLS

Criteria are identical to those for knee osteoarthritis patients above, but controls will have no clinical or radiographic evidence of osteoarthritis and will have normal activity physical activity levels.

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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Other
    Resistance exercise training

    Exercise is being used as an experimental tool to determine if remediation of muscle disuse counteracts cellular/molecular defects in muscle structure/function.

    Behavioral: Resistance exercise training

Interventions

  • BehavioralResistance exercise training

    Lower extremity resistance exercise training 3x/wk

06

What researchers measure

Primary outcomes

  1. Single muscle fiber structure/function

    Time frame: Baseline

  2. Single muscle fiber structure/function

    Time frame: 3.5 months (post-training)

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Study locations

1 site
  • University of Vermont and State Agricultural College
    Burlington, Vermont 05405, United States
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References and documents

Publications

  • Gustavson AM, Wolfe P, Falvey JR, Eckhoff DG, Toth MJ, Stevens-Lapsley JE. Men and Women Demonstrate Differences in Early Functional Recovery After Total Knee Arthroplasty. Arch Phys Med Rehabil. 2016 Jul;97(7):1154-62. doi: 10.1016/j.apmr.2016.03.007. Epub 2016 Apr 8. PubMed 27063363 ↗
  • Rengo JL, Callahan DM, Savage PD, Ades PA, Toth MJ. Skeletal muscle ultrastructure and function in statin-tolerant individuals. Muscle Nerve. 2016 Feb;53(2):242-51. doi: 10.1002/mus.24722. Epub 2015 Dec 9. PubMed 26059690 ↗
  • Miller MS, Bedrin NG, Ades PA, Palmer BM, Toth MJ. Molecular determinants of force production in human skeletal muscle fibers: effects of myosin isoform expression and cross-sectional area. Am J Physiol Cell Physiol. 2015 Mar 15;308(6):C473-84. doi: 10.1152/ajpcell.00158.2014. Epub 2015 Jan 7. PubMed 25567808 ↗
  • Callahan DM, Bedrin NG, Subramanian M, Berking J, Ades PA, Toth MJ, Miller MS. Age-related structural alterations in human skeletal muscle fibers and mitochondria are sex specific: relationship to single-fiber function. J Appl Physiol (1985). 2014 Jun 15;116(12):1582-92. doi: 10.1152/japplphysiol.01362.2013. Epub 2014 May 1. PubMed 24790014 ↗
  • Miller MS, Bedrin NG, Callahan DM, Previs MJ, Jennings ME 2nd, Ades PA, Maughan DW, Palmer BM, Toth MJ. Age-related slowing of myosin actin cross-bridge kinetics is sex specific and predicts decrements in whole skeletal muscle performance in humans. J Appl Physiol (1985). 2013 Oct 1;115(7):1004-14. doi: 10.1152/japplphysiol.00563.2013. Epub 2013 Jul 25. PubMed 23887900 ↗
  • Callahan DM, Tourville TW, Slauterbeck JR, Ades PA, Stevens-Lapsley J, Beynnon BD, Toth MJ. Reduced rate of knee extensor torque development in older adults with knee osteoarthritis is associated with intrinsic muscle contractile deficits. Exp Gerontol. 2015 Dec;72:16-21. doi: 10.1016/j.exger.2015.08.016. Epub 2015 Sep 3. PubMed 26343257 ↗
  • Callahan DM, Tourville TW, Miller MS, Hackett SB, Sharma H, Cruickshank NC, Slauterbeck JR, Savage PD, Ades PA, Maughan DW, Beynnon BD, Toth MJ. Chronic disuse and skeletal muscle structure in older adults: sex-specific differences and relationships to contractile function. Am J Physiol Cell Physiol. 2015 Jun 1;308(11):C932-43. doi: 10.1152/ajpcell.00014.2015. Epub 2015 Mar 25. PubMed 25810256 ↗
  • Miller MS, Callahan DM, Toth MJ. Skeletal muscle myofilament adaptations to aging, disease, and disuse and their effects on whole muscle performance in older adult humans. Front Physiol. 2014 Sep 26;5:369. doi: 10.3389/fphys.2014.00369. eCollection 2014. PubMed 25309456 ↗
  • Callahan DM, Miller MS, Sweeny AP, Tourville TW, Slauterbeck JR, Savage PD, Maugan DW, Ades PA, Beynnon BD, Toth MJ. Muscle disuse alters skeletal muscle contractile function at the molecular and cellular levels in older adult humans in a sex-specific manner. J Physiol. 2014 Oct 15;592(20):4555-73. doi: 10.1113/jphysiol.2014.279034. Epub 2014 Jul 18. PubMed 25038243 ↗
  • Voigt TB, Tourville TW, Falcone MJ, Slauterbeck JR, Beynnon BD, Toth MJ. Resistance training-induced gains in knee extensor strength are related to increased neural cell adhesion molecule expression in older adults with knee osteoarthritis. BMC Res Notes. 2019 Sep 18;12(1):595. doi: 10.1186/s13104-019-4642-0. PubMed 31533814 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01190046
Lead sponsor
University of Vermont
Collaborators
National Institute on Aging (NIA)
Responsible party
Michael J. Toth, Ph.D. (Associate Professor of Medicine, University of Vermont) — Principal investigator
First posted
Aug 27, 2010
Start date
Oct 2010
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Nov 16, 2016

Study contacts

Michael J. Toth, Ph.D.
principal investigator · University of Vermont and State Agricultural College

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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