NCT01190046

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 16, 2016

Status Verified

November 1, 2016

Enrollment Period

5.7 years

First QC Date

August 25, 2010

Last Update Submit

November 15, 2016

Conditions

Osteoarthritis

Keywords

elderlymuscledisuseosteoarthritisexercise

Outcome Measures

Primary Outcomes (2)

  • Single muscle fiber structure/function

    Baseline

  • Single muscle fiber structure/function

    3.5 months (post-training)

Study Arms (1)

Resistance exercise training

OTHER

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

Resistance exercise trainingBEHAVIORAL

Lower extremity resistance exercise training 3x/wk

Resistance exercise training

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vermont and State Agricultural College

Burlington, Vermont, 05405, United States

Location

Related Publications (10)

  • 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.

    PMID: 27063363BACKGROUND

  • 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.

    PMID: 26059690BACKGROUND

  • 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.

    PMID: 25567808BACKGROUND

  • 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.

    PMID: 24790014BACKGROUND

  • 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.

    PMID: 23887900BACKGROUND

  • 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.

    PMID: 26343257RESULT

  • 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.

    PMID: 25810256RESULT

  • 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.

    PMID: 25309456RESULT

  • 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.

    PMID: 25038243RESULT

  • 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.

    PMID: 31533814DERIVED

MeSH Terms

Conditions

OsteoarthritisMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Michael J. Toth, Ph.D.

    University of Vermont and State Agricultural College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

August 25, 2010

First Posted

August 27, 2010

Study Start

October 1, 2010

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

November 16, 2016

Record last verified: 2016-11

Locations

US(1)