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OsteoarthritisNCT01190046

Chronic Muscle Disuse in the Elderly

A study testing Resistance exercise training in people with Osteoarthritis, run by University of Vermont at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Osteoarthritis
What is being tested?
Resistance exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
Oct 2010to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

Other trials in United States

About this study

Official title: Muscle Disuse and Contractile Dysfunction in the Elderly

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.

Conditions
Osteoarthritis
Being tested
Resistance exercise training
Keywords
elderly, muscle, disuse, osteoarthritis, exercise
Medical subject headings
Osteoarthritis, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resistance exercise trainingBehavioural

    Lower extremity resistance exercise training 3x/wk

Study groups in NCT01190046
Study groupRoleWhat they receive
Resistance exercise trainingOtherExercise is being used as an experimental tool to determine if remediation of muscle disuse counteracts cellular/molecular defects in muscle structure/function.
Receives: Behavioral: Resistance exercise training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Single muscle fiber structure/function

    Measured: Baseline

  2. Single muscle fiber structure/function

    Measured: 3.5 months (post-training)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01190046
Sponsor's protocol ID
033547
Other IDs
R01AG033547
Status last verified
Nov 2016
First submitted
25 Aug 2010
Last updated
16 Nov 2016
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Resistance exercise training in people with Osteoarthritis, run by University of Vermont at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Single muscle fiber structure/function (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01190046, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2016.

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