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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
the concentric isokinetic exercise group
the eccentric isokinetic exercise group
the control group
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Concentric, Eccentric, Muscle Architecture, Proprioception

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

the concentric isokinetic exercise group

the eccentric isokinetic exercise group

the control group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Joint position sense
Joint position sense will be evaluated with isokinetic dynamometer at predetermined angles.
Ultrasonographic assessment of quadriceps and hamstring muscles
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

WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index)
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.
Range of motion
Universal goniometer will be used for assessment of range of motion of the knee
Muscle strength assessment
isokinetic dynamometer test will be used.
Shortness of muscles assessment
universal goniometer will be used for assessment
Pain assessment: VAS (Visual analog scale)
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.
Balance assessment
Single leg standing test with eyes open and closed will be used. Timing is recorded.
The timed up and go test
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.
Sit to stand test
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.
Timed 10 meter walk test
This test is used to assess walking speed. Timing is recorded.
Short Form 12 (SF-12) health survey
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.

Full Information

First Posted
February 20, 2019
Last Updated
April 27, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03920020
Brief Title
Comparison of The Effects of Concentric And Eccentric Isokinetic Exercises in Patients With Knee Osteoarthritis
Official Title
Comparison of The Effects of Concentric and Eccentric Isokinetic Exercises on Proprioception and Muscle Architecture in Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 28, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Concentric, Eccentric, Muscle Architecture, Proprioception

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the concentric isokinetic exercise group
Arm Type
Other
Arm Description
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.
Arm Title
the eccentric isokinetic exercise group
Arm Type
Other
Arm Description
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.
Arm Title
the control group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
the concentric isokinetic exercise group
Intervention Description
concentric isokinetic exercises
Intervention Type
Other
Intervention Name(s)
the eccentric isokinetic exercise group
Intervention Description
eccentric isokinetic exercises
Intervention Type
Other
Intervention Name(s)
the control group
Intervention Description
conventional physiotherapy and standard therapeutic exercises predetermined by us
Primary Outcome Measure Information:
Title
Joint position sense
Description
Joint position sense will be evaluated with isokinetic dynamometer at predetermined angles.
Time Frame
6 weeks
Title
Ultrasonographic assessment of quadriceps and hamstring muscles
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index)
Description
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.
Time Frame
6 weeks
Title
Range of motion
Description
Universal goniometer will be used for assessment of range of motion of the knee
Time Frame
6 weeks
Title
Muscle strength assessment
Description
isokinetic dynamometer test will be used.
Time Frame
6 weeks
Title
Shortness of muscles assessment
Description
universal goniometer will be used for assessment
Time Frame
6 weeks
Title
Pain assessment: VAS (Visual analog scale)
Description
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.
Time Frame
6 weeks
Title
Balance assessment
Description
Single leg standing test with eyes open and closed will be used. Timing is recorded.
Time Frame
6 weeks
Title
The timed up and go test
Description
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.
Time Frame
6 weeks
Title
Sit to stand test
Description
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.
Time Frame
6 weeks
Title
Timed 10 meter walk test
Description
This test is used to assess walking speed. Timing is recorded.
Time Frame
6 weeks
Title
Short Form 12 (SF-12) health survey
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysun Baki, phd student
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Health Sciences
City
Ankara
State/Province
Altındağ
ZIP/Postal Code
06030
Country
Turkey

12. IPD Sharing Statement

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

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