Knee OsteoarthritisNCT03920020
Comparison of The Effects of Concentric And Eccentric Isokinetic Exercises in Patients With Knee Osteoarthritis
A study testing the concentric isokinetic exercise group and the eccentric isokinetic exercise group in people with Knee Osteoarthritis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- the concentric isokinetic exercise group and the eccentric isokinetic exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jan 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Institute of Health Sciences
Ankara, Altındağ, 06030
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- the concentric isokinetic exercise group, the eccentric isokinetic exercise group, the control group
- Keywords
- Concentric, Eccentric, Muscle Architecture, Proprioception
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the concentric isokinetic exercise groupOther
concentric isokinetic exercises
the eccentric isokinetic exercise groupOther
eccentric isokinetic exercises
the control groupOther
conventional physiotherapy and standard therapeutic exercises predetermined by us
| Study group | Role | What they receive |
|---|---|---|
| the concentric isokinetic exercise group | Other | 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. Receives: Other: the concentric isokinetic exercise group; Other: the control group |
| the eccentric isokinetic exercise group | Other | 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. Receives: Other: the eccentric isokinetic exercise group; Other: the control group |
| the control group | Other | 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. Receives: Other: the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint position sense
Joint position sense will be evaluated with isokinetic dynamometer at predetermined angles.
Measured: 6 weeks
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.
Measured: 6 weeks
Secondary outcomes (10)
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.
Measured: 6 weeks
Range of motion
Universal goniometer will be used for assessment of range of motion of the knee
Measured: 6 weeks
Muscle strength assessment
isokinetic dynamometer test will be used.
Measured: 6 weeks
Shortness of muscles assessment
universal goniometer will be used for assessment
Measured: 6 weeks
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.
Measured: 6 weeks
Balance assessment
Single leg standing test with eyes open and closed will be used. Timing is recorded.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
Timed 10 meter walk test
This test is used to assess walking speed. Timing is recorded.
Measured: 6 weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start28 Jan 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysun Baki, Hacettepe University
- Investigators
- Aysun Baki, phd student, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920020
- Sponsor's protocol ID
- KA 17168
- Status last verified
- Apr 2023
- First submitted
- 20 Feb 2019
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Effects of Concentric and Eccentric Isokinetic Exercises on Proprioception and Muscle Architecture in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03920020
- Acronym / sponsor ID
- KA 17168
- Conditions
- Knee Osteoarthritis
- Keywords
- Concentric, Eccentric, Muscle Architecture, Proprioception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the concentric isokinetic exercise group | Other | Other: the concentric isokinetic exercise group, Other: the control groupthe 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 | Other | Other: the eccentric isokinetic exercise group, Other: the control groupthe 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 | Other | Other: the control groupthe 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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the concentric isokinetic exercise groupconcentric isokinetic exercises | Other | the concentric isokinetic exercise group |
| the eccentric isokinetic exercise groupeccentric isokinetic exercises | Other | the eccentric isokinetic exercise group |
| the control groupconventional physiotherapy and standard therapeutic exercises predetermined by us | Other | the concentric isokinetic exercise group, the control group, the eccentric isokinetic exercise group |
Primary outcome
Joint position sense
Time frame: 6 weeks
Joint position sense will be evaluated with isokinetic dynamometer at predetermined angles.
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.
10 secondary outcomes
WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index)
Time frame: 6 weeks
Range of motion
Time frame: 6 weeks
Muscle strength assessment
Time frame: 6 weeks
Shortness of muscles assessment
Time frame: 6 weeks
Pain assessment: VAS (Visual analog scale)
Time frame: 6 weeks
Balance assessment
Time frame: 6 weeks
The timed up and go test
Time frame: 6 weeks
Sit to stand test
Time frame: 6 weeks
Timed 10 meter walk test
Time frame: 6 weeks
Short Form 12 (SF-12) health survey
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aysun Baki, phd student principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the concentric isokinetic exercise group and the eccentric isokinetic exercise group in people with Knee Osteoarthritis, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint position sense (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.