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CompletedNCT02350387Updated Feb 26, 2016

Efficacy of Eccentric Resistance Training in Persons With Knee Osteoarthritis

An interventional study of High Intensity Short Duration Exercise and Low intensity Long Duration Exercise in Osteoarthritis, sponsored by Regis University. Completed at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2016-02-26.

Sponsored by Regis University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine if there are differences in balance, strength, functional performance and self-reported outcomes for subjects with knee osteoarthritis who complete a low intensity, long duration eccentric training program compared to those who complete a high intensity, short duration eccentric training program. This study will be utilizing the Eccentron (manufactured by BTE Technologies) for the performance of all eccentric exercise.

Read the detailed description

Arthritis is the leading cause of disability in the United States. Osteoarthritis (OA) is the most common type of arthritis and affects nearly 27 million Americans. Knee OA is the most common type of osteoarthritis and is estimated to affect 42.1% of women and 31.2% of men over the age of 60.

Osteoarthritis is most likely multi-factorial with several underlying causes. It is no longer considered "a degenerative joint disease" but rather a process that involves dynamic biomechanical, biochemical, and cellular processes. It not only involves degeneration of the articular cartilage, but also inflammation of the synovium, changes to the underlying subchondral bone, and the development of osteophytes. Currently, it appears that numerous systemic factors can lead to the initiation of OA through different causal pathways . These systemic causes can then be amplified by local factors such as trauma or increased loading caused by obesity.

Currently, there is no "cure" for OA and attempts to find a disease modifying drug have been unsuccessful. Thus, treatment currently focuses on mitigating factors that are known to affect the radiographic progression of the disease as well as lead to activity limitation and participation restriction.9,10 Decreases in lower extremity strength are a major cause of activity limitations given the vital role of strength in activities of daily living.

One method that is used to mitigate progressing factors is through the use of an exercise program. Many types of exercise have been used successfully in the literature including resistance training. Resistance training can take many different forms such as isometric, isotonic (concentric and/or eccentric) or isokinetic with various intensities. Presently, there is little evidence for the use of eccentric training interventions for patients with knee OA. This study aims to further examine this type of resistance training for the OA population. Therefore, the purpose of this study is to examine the effects of low intensity, long duration eccentric resistance training and high intensity, short duration eccentric resistance training in individuals with knee OA. Ideally, this study will allow us to determine the overall effects of eccentric resistance training as well as the potential differences of the two types of eccentric resistance training.

02

Conditions studied

  • Osteoarthritis

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03

In context

Osteoarthritis

4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 32 is below the median of 70 across 3,474 interventional studies indexed under Osteoarthritis.

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Lead sponsor

Regis University is the lead sponsor of 10 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Individuals will be included in the study if they are:

  • at least 55 years old,
  • cognitively able to understand directions,
  • able to ambulate at least 50 feet without stopping,
  • are currently experiencing knee pain and
  • meet at least 3 out of 6 criteria of the European League Against Rheumatism (EULAR) criteria for knee osteoarthritis diagnosis.

Exclusion criteria

Exclusion Criteria:

Individuals will be excluded from the study if they have:

  • a diagnosed medical condition that would limit physical ability, including acute or active fractures, myocardial infarctions, stroke,
  • a traumatic brain injury within the last 6 months, or
  • joint replacement within the last 12 months. Individuals with chronic neurological disorders limiting motion or present with any known contraindication for balance training will also be excluded from the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    High Intensity Short Duration Exercise

    Participants randomized to this group will perform 4 sets of 8-15 repetitions of eccentric exercise using the Eccentron set at 50-80% of the participant's one repetition maximum.

    Procedure: High Intensity Short Duration Exercise

  • Experimental
    Low Intensity Long Duration Exercise

    Participants randomized to this group will perform 5-20 minutes of continuous eccentric exercise using the Eccentron set at 50% of the participant's one repetition maximum.

    Procedure: Low intensity Long Duration Exercise

Interventions

  • ProcedureHigh Intensity Short Duration Exercise

    Participants randomized to this group will perform 4 sets of 8-15 repetitions of eccentric exercise using the Eccentron set at 50-80% of the participant's one repetition maximum.

  • ProcedureLow intensity Long Duration Exercise

    Participants randomized to this group will perform 5-20 minutes of continuous eccentric exercise using the Eccentron set at 50% of the participant's one repetition maximum.

06

What researchers measure

Primary outcomes

  1. Isometric quadriceps strength as measured by a hand held dynamometer

    The primary outcome for this study is the change in quadriceps strength from baseline to 8 weeks (end of intervention) in both experimental groups.

    Time frame: Change from baseline to 8 weeks

Secondary outcomes

  1. Lower extremity muscle strength as measured by a hand held dynamometer

    Trunk flexion/extension, Hip Abduction/Extension, Knee Flexion/Extension, and Ankle Plantarflexion and Dorsiflexion will be assessed at baseline and 8 weeks by a hand held dynamometer.

    Time frame: Change from baseline to 8 weeks

  2. Timed Up and Go Test

    Time frame: Change from baseline to 8 weeks

  3. 6-minute Walk Test

    Time frame: Change from baseline to 8 weeks

  4. Five times sit to stand test

    Time frame: Change from baseline to 8 weeks

  5. Balance (assessed utilizing the romberg, sharpened romberg, one-legged stance test, functional reach test, and step test)

    Balance will be assessed utilizing the romberg, sharpened romberg, one-legged stance test, functional reach test, and step test.

    Time frame: Change from baseline to 8 weeks

  6. Arthritis Impact Measurement Scale (AIMS)

    Time frame: Change from baseline to 8 weeks

  7. Pain and muscle soreness ( assessed utilizing a numeric pain rating scale)

    Pain and muscle soreness will be assessed utilizing a numeric pain rating scale at the beginning and end of every treatment session.

    Time frame: At the beginning of every treatment session and following every treatment session for the 8 week intervention

07

Study locations

1 site
  • Regis University
    Denver, Colorado 80221, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2015, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 20, 2015
First posted
Jan 29, 2015
Start
Jan 2015
Primary completionActual
Dec 2015
CompletionActual
Dec 2015
Last update
Feb 26, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02350387
Lead sponsor
Regis University
Responsible party
Michael Bade (Assistant Professor, Regis University) — Principal investigator
First posted
Jan 29, 2015
Start date
Jan 2015
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Feb 26, 2016

Study contacts

Michael J Bade, PT, PhD
principal investigator · Regis University

Oversight

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

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

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