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Comparison of The Effects of Concentric And Eccentric Isokinetic Exercises in Patients With Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03920020
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Aysun Baki, Hacettepe University

Study Description
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Brief Summary:
This study aims to compare the effects of concentric and eccentric isokinetic exercises on proprioception and muscle architecture in 69 patients with knee osteoarthritis enrolled the study.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: the concentric isokinetic exercise group Other: the eccentric isokinetic exercise group Other: the control group Not Applicable

Detailed Description:
This study aims to compare the effects of concentric and eccentric isokinetic exercises on proprioception and muscle architecture in patients with knee osteoarthritis. 69 patients will be included in this study. Patients will be divided into three groups; concentric exercise group (n:23), eccentric exercise group (n:23) and control group (n:23). A conventional physiotherapy program and a standard therapeutic exercise program will be applied to all subjects. In addition to these exercise and physiotherapy programme, concentric and eccentric exercise groups will perform the exercises related to their groups. All three groups will participate in this program for a total of 18 sessions 3 times a week for 6 weeks. All groups will be subject to re-evaluation after 6 weeks.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of The Effects of Concentric and Eccentric Isokinetic Exercises on Proprioception and Muscle Architecture in Patients With Knee Osteoarthritis
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

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Arms and Interventions
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Arm Intervention/treatment
the concentric isokinetic exercise group
the concentric isokinetic exercise group will perform quadriceps and hamstring concentric isokinetic exercises in addition to the conventional physiotherapy and exercise program 3 times a week during 6 weeks.
 Other: the concentric isokinetic exercise group
concentric isokinetic exercises

Other: the control group
conventional physiotherapy and standard therapeutic exercises predetermined by us
the eccentric isokinetic exercise group
the eccentric isokinetic exercise group will perform quadriceps and hamstring eccentric isokinetic exercises in addition to the conventional physiotherapy and exercise program 3 times a week during 6 weeks.
 Other: the eccentric isokinetic exercise group
eccentric isokinetic exercises

Other: the control group
conventional physiotherapy and standard therapeutic exercises predetermined by us
the control group
the control group will perform the standard exercise program predetermined by us consisting of stretching exercises and isometric strengthening (these exercises will be done at home, too) and the conventional physiotherapy program will be applied 3 times a week during 6 weeks.
 Other: the control group
conventional physiotherapy and standard therapeutic exercises predetermined by us


Outcome Measures
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Primary Outcome Measures :
  1. Joint position sense [ Time Frame: 6 weeks ]
    Joint position sense will be evaluated with isokinetic dynamometer at predetermined angles.

  2. Ultrasonographic assessment of quadriceps and hamstring muscles [ Time Frame: 6 weeks ]
    Ultrasonographic evaluation is an outcome measure to evaluate muscle structure. In our study ultrasonographic evaluation will be performed to determine the muscle structure (muscle thickness(mm), fascicle length(mm), pennation angle(degree)) of quadriceps and hamstring muscles. Muscle thickness will be defined as the distance between the deeper and upper aponeurosis. The pennation angle will be calculated as the angle of insertion of muscle fascicles into the deep aponeurosis. Fascicle length will be defined as the length of the fascicular path between the superficial and deep aponeurosis.


Secondary Outcome Measures :
  1. WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index) [ Time Frame: 6 weeks ]
    WOMAC Osteoarthritis Index (score range 0-100) include 3 subscales and will be used to evaluate knee pain(score range 0-20), stiffness (score range 0-8), and functional limitation (score range -68). Womac is comprised of 24 items ( pain-5 items, stiffness-2 items, physical function-17 items). All items are scored on a scale of 0-4. Lower scores indicate lower disability.

  2. Range of motion [ Time Frame: 6 weeks ]
    Universal goniometer will be used for assessment of range of motion of the knee

  3. Muscle strength assessment [ Time Frame: 6 weeks ]
    isokinetic dynamometer test will be used.

  4. Shortness of muscles assessment [ Time Frame: 6 weeks ]
    universal goniometer will be used for assessment

  5. Pain assessment: VAS (Visual analog scale) [ Time Frame: 6 weeks ]
    VAS is used to measure the psycometric pain severity in some conditions and activities. A VAS is usually a 100 mm long horizontal line. The scale is most commonly anchored by "no pain" (line's left, score-0), "pain as bad as it could be" (line's right, score-100). the score is determined by measuring the distance between the "no pain" anchor and the patient's mark.

  6. Balance assessment [ Time Frame: 6 weeks ]
    Single leg standing test with eyes open and closed will be used. Timing is recorded.

  7. The timed up and go test [ Time Frame: 6 weeks ]
    TUG test is used to measure functional mobility. It gives an idea about patients walking ability, fall risk and balance. The patient is asked to get up, walk 3 meters and sit down again.Timing begins when the patient rise from the chair and stops when the patient sit down.

  8. Sit to stand test [ Time Frame: 6 weeks ]
    Patients stand up from and sit down on a chair as quickly as possible 5 times. Patients folded their arms across their chests. Timing is recorded.

  9. Timed 10 meter walk test [ Time Frame: 6 weeks ]
    This test is used to assess walking speed. Timing is recorded.

  10. Short Form 12 (SF-12) health survey [ Time Frame: 6 weeks ]
    SF-12 is an 12- item questionnare for assessing self-reported health related quality of life. It covers eight domains of health outcomes, including physical functioning, role physical, bodily pain, general health, vitality, social functioning,role-emotional, mental health. Sf-12 physical and mental component summary scales are scored. Lower SF-12 score indicated poorer physical and mental health.


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of primary knee osteoarthritis according to American College of Radiology
  • Being radiographically K-L grade 2-3
  • Presence of symptoms for at least 3 months
  • Patients who have been planned a conventional physiotherapy programme because of knee osteoarthritis
  • Presence of functional capacity for outpatient physical therapy

Exclusion Criteria:

  • Patients with seconder knee osteoarthritis
  • History of lower extremity or spine surgery
  • History of intraarticular injection in last 1 month
  • Patients with neurological disease that will affect muscle strength, balance and coordination
Contacts and Locations
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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): NCT03920020


Contacts
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Contact: Nezire Köse, Prof. +905425281543 fztnezire@yahoo.com
Contact: Aysun Baki, phd student +905555105805 aysunsat@hotmail.com

Locations
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Turkey
Institute of Health Sciences Recruiting
Ankara, Altındağ, Turkey, 06030
Contact: Nezire Köse, Prof.    +905425281543    fztnezire@yahoo.com   
Contact: Aysun Baki, phd student    +905555105805    aysunsat@hotmail.com   
Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: Aysun Baki, phd student Hacettepe University
More Information
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Responsible Party: Aysun Baki, principal investigator, Hacettepe University
ClinicalTrials.gov Identifier: NCT03920020    
Other Study ID Numbers: KA 17168
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aysun Baki, Hacettepe University:
Concentric
Eccentric
Muscle Architecture
Proprioception
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases