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Efficacy of Eccentric Resistance Training in Persons With Knee Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Intensity Short Duration Exercise
Low intensity Long Duration Exercise
Sponsored by
Regis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Regis University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High Intensity Short Duration Exercise

Low Intensity Long Duration Exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Timed Up and Go Test
6-minute Walk Test
Five times sit to stand test
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.
Arthritis Impact Measurement Scale (AIMS)
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.

Full Information

First Posted
January 20, 2015
Last Updated
February 25, 2016
Sponsor
Regis University
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1. Study Identification

Unique Protocol Identification Number
NCT02350387
Brief Title
Efficacy of Eccentric Resistance Training in Persons With Knee Osteoarthritis
Official Title
Efficacy of Eccentric Resistance Training in Persons With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regis University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Short Duration Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Low Intensity Long Duration Exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
High Intensity Short Duration Exercise
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Low intensity Long Duration Exercise
Intervention Description
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 Measure Information:
Title
Isometric quadriceps strength as measured by a hand held dynamometer
Description
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 Outcome Measure Information:
Title
Lower extremity muscle strength as measured by a hand held dynamometer
Description
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
Title
Timed Up and Go Test
Time Frame
Change from baseline to 8 weeks
Title
6-minute Walk Test
Time Frame
Change from baseline to 8 weeks
Title
Five times sit to stand test
Time Frame
Change from baseline to 8 weeks
Title
Balance (assessed utilizing the romberg, sharpened romberg, one-legged stance test, functional reach test, and step test)
Description
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
Title
Arthritis Impact Measurement Scale (AIMS)
Time Frame
Change from baseline to 8 weeks
Title
Pain and muscle soreness ( assessed utilizing a numeric pain rating scale)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Bade, PT, PhD
Organizational Affiliation
Regis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regis University
City
Denver
State/Province
Colorado
ZIP/Postal Code
80221
Country
United States

12. IPD Sharing Statement

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Efficacy of Eccentric Resistance Training in Persons With Knee Osteoarthritis

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