- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03920020
Comparison of The Effects of Concentric And Eccentric Isokinetic Exercises in Patients With Knee Osteoarthritis
April 27, 2023 updated by: Aysun Baki, Hacettepe University
Comparison of The Effects of Concentric and Eccentric Isokinetic Exercises on Proprioception and Muscle Architecture in Patients With Knee Osteoarthritis
This study aims to compare the effects of concentric and eccentric isokinetic exercises on proprioception and muscle architecture in 42 patients with knee osteoarthritis enrolled the study.
Study Overview
Status
Completed
Conditions
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.
42 patients will be included in this study.
Patients will be divided into three groups; concentric exercise group (n:14), eccentric exercise group (n:14) and control group (n:14).
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 Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nezire Köse, Prof.
- Phone Number: +905425281543
- Email: fztnezire@yahoo.com
Study Contact Backup
- Name: Aysun Baki, phd student
- Phone Number: +905555105805
- Email: aysunsat@hotmail.com
Study Locations
-
-
Altındağ
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Ankara, Altındağ, Turkey, 06030
- Institute of Health Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
concentric isokinetic exercises
conventional physiotherapy and standard therapeutic exercises predetermined by us
|
Other: 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.
|
conventional physiotherapy and standard therapeutic exercises predetermined by us
eccentric isokinetic exercises
|
Other: 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.
|
conventional physiotherapy and standard therapeutic exercises predetermined by us
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Joint position sense
Time Frame: 6 weeks
|
Joint position sense will be evaluated with isokinetic dynamometer at predetermined angles.
|
6 weeks
|
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.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 weeks
|
Range of motion
Time Frame: 6 weeks
|
Universal goniometer will be used for assessment of range of motion of the knee
|
6 weeks
|
Muscle strength assessment
Time Frame: 6 weeks
|
isokinetic dynamometer test will be used.
|
6 weeks
|
Shortness of muscles assessment
Time Frame: 6 weeks
|
universal goniometer will be used for assessment
|
6 weeks
|
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 weeks
|
Balance assessment
Time Frame: 6 weeks
|
Single leg standing test with eyes open and closed will be used.
Timing is recorded.
|
6 weeks
|
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.
|
6 weeks
|
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.
|
6 weeks
|
Timed 10 meter walk test
Time Frame: 6 weeks
|
This test is used to assess walking speed.
Timing is recorded.
|
6 weeks
|
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.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aysun Baki, phd student, Hacettepe University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 28, 2019
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
February 20, 2019
First Submitted That Met QC Criteria
April 17, 2019
First Posted (Actual)
April 18, 2019
Study Record Updates
Last Update Posted (Actual)
April 28, 2023
Last Update Submitted That Met QC Criteria
April 27, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA 17168
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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