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Efficacy of Eccentric Resistance Training in Persons With Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02350387
Recruitment Status : Completed
First Posted : January 29, 2015
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
Michael Bade, Regis University

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: High Intensity Short Duration Exercise Procedure: Low intensity Long Duration Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Eccentric Resistance Training in Persons With Knee Osteoarthritis
Study Start Date : January 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.

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
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.




Primary Outcome Measures :
  1. Isometric quadriceps strength as measured by a hand held dynamometer [ Time Frame: Change from baseline to 8 weeks ]
    The primary outcome for this study is the change in quadriceps strength from baseline to 8 weeks (end of intervention) in both experimental groups.


Secondary Outcome Measures :
  1. Lower extremity muscle strength as measured by a hand held dynamometer [ Time Frame: Change from baseline to 8 weeks ]
    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.

  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) [ Time Frame: Change from baseline to 8 weeks ]
    Balance will be assessed utilizing the romberg, sharpened romberg, one-legged stance test, functional reach test, and step test.

  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) [ Time Frame: At the beginning of every treatment session and following every treatment session for the 8 week intervention ]
    Pain and muscle soreness will be assessed utilizing a numeric pain rating scale at the beginning and end of every treatment session.



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350387


Locations
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United States, Colorado
Regis University
Denver, Colorado, United States, 80221
Sponsors and Collaborators
Regis University
Investigators
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Principal Investigator: Michael J Bade, PT, PhD Regis University
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Responsible Party: Michael Bade, Assistant Professor, Regis University
ClinicalTrials.gov Identifier: NCT02350387    
Other Study ID Numbers: 15-010
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: February 26, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Oxymetazoline
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents