Osteo Arthritis KneeNCT04186143
Effects of Closed and Open Kinetic Chain Exercises
A study testing Closed Cinetic Chain Exercises and Open Kinetic Chain Exercises in people with Osteo Arthritis Knee, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Osteoarthritis (OA) is a heterogeneous pathology characterized by focal cartilage degeneration and the formation of new bone around the subchondral bone and joint, which is the disruption of balance between the processes of destruction and repair in subchondral area. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Closed Cinetic Chain Exercises and Open Kinetic Chain Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2017to 20 Jul 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the presence of knee osteoarthritis Grade 2 and Grade 3 based on Kellgren Lawrence Classification,
- volunteering to participate in the study.
Who cannot join
- the presence of active synovitis,
- participation physiotherapy program in the last 6 months,
- systemic and cardiovascular diseases,
- neurological and orthopedic problems affecting walking and standing,
- lower extremity surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Closed and Open Kinetic Chain Exercises on Pain, Muscles Strength, Function, and Quality of Life In Patients With Knee Osteoarthritis In Patients With Knee Osteoarthritis
Osteoarthritis (OA) is a heterogeneous pathology characterized by focal cartilage degeneration and the formation of new bone around the subchondral bone and joint, which is the disruption of balance between the processes of destruction and repair in subchondral area. Knee OA is a considerable cause of disability and is present in 2-3% of all disability causes. Exercises are more noticeable than other methods because they are an easy method, low cost and long-lasting. To the best of our knowledge, the studies based on this topic are scarce. Therefore, the aim of this study was to compare the effects of open and closed kinetic chain exercises on pain, functional level, quality of life and muscle strength in patients with knee osteoarthritis.
Read the detailed description
Osteoarthritis (OA) is a heterogeneous pathology characterized by degeneration of the posterior focal cartilage and the formation of new bone around the subchondral bone and joint, which is the disruption of the balance between the processes of destruction and repair of the joint cartilage and subchondral region. Radiologically, OA was reported in the majority of people over 65 years old and in 80% of those over 75 years old. OA is the most common joint disease in the world. Knee OA is an important health problem due to pain, functional disability and reduced quality of life in patients. Studies have shown that knee OA is associated with inadequacy and pain associated with decreased quadriceps muscle strength. Strengthening education has been shown to have positive effects on OA.
Knee OA is a significant disability cause and is present in 3% of all disability causes. OA causes disability and consequent labor loss and economic loss. Therefore, OA therapy gains importance. OA therapy is classified under three headings as pharmacological methods, non-pharmacological methods and surgical methods. In non-pharmacological methods, there are a number of studies showing the effectiveness of exercise in particular. Because it is an easy method, the cost is low and it is applicable for a long time, the exercises are more important than other methods. The literature on exercise programs with optimal gains for knee osteoarthritis has not yet been established, with numerous studies reporting the importance of different types of exercise for the treatment of knee OA in the literature. Open kinetic chain exercises are frequently used to strengthen the quadriceps muscle. Closed kinetic chain exercises have been shown to increase muscle strength and improve proprioceptive function by activating more muscle spindle and joint proprioceptors. In literature, there are researches that compare closed and open kinetic chain exercises. However, these studies mostly focus on exercises after anterior cruciate ligament reconstruction. The aim of this study was to compare the effects of open and closed kinetic chain exercises on pain, functional level, quality of life and muscle strength in patients with knee osteoarthritis.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Closed Cinetic Chain Exercises, Open Kinetic Chain Exercises, Control Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed Cinetic Chain ExercisesOther
Sit to stand, mini squat, anterior lunge, step up exercises are performed as Closed Cinetic Chain Exercises.
Open Kinetic Chain ExercisesOther
Isometric quadriceps, isotonic quadriceps, hip extension and hip adduction exercises are performed as Open Kinetic Chain Exercises.
Control GroupOther
Control Group was followed up by conservative treatment and home program for 12 weeks and they were asked to apply the home program three days in a week. Exercise brochure was handed out for home program. Quadriceps strength and harmstring stretch exercises were applied.
| Study group | Role | What they receive |
|---|---|---|
| Experimental-Study Group | Experimental | In addition to the conservative treatment of the control group, closed cinetic chain exercises were applied for 12 weeks. Receives: Other: Closed Cinetic Chain Exercises |
| Active Comparator | Active comparator | In addition to the conservative treatment of the control group, opened cinetic chain exercises were applied for 12 weeks. Receives: Other: Open Kinetic Chain Exercises |
| Control Group | Other | Conservative treatment was applied for 12 weeks. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (Pain)
The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. The 11-point numeric scale ranges from '0' representing no pain to '10' representing pain as bad as you can imagine or worst pain imaginable.
Measured: 12 weeks
Secondary outcomes (5)
The WOMAC Index (Functional Level)
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) was used for functional level of participants. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright; Stiffness (2 items): after first waking and later in the day; Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
Measured: 12 weeks
Biodex System Pro 4 Isokinetic Strength Dynamometer (Muscle Strength)
Muscle strength of participants were assessed with this device. Five repeated isokinetic muscle strength tests was performed at 90º / s angular velocity in order to determine the maximal muscle strength of the muscles of the lower limb M. Quadriceps femoris and Hamstring group.
Measured: 12 weeks
Biodex System Pro 4 Isokinetic Strength Dynamometer (Muscle Strength)
Muscle strength of participants were assessed with this device. Five repeated isokinetic muscle strength tests was performed at 120º / s angular velocity in order to determine the maximal muscle strength of the muscles of the lower limb M. Quadriceps femoris and Hamstring group.
Measured: 12 weeks
Biodex System Pro 4 Isokinetic Strength Dynamometer (Muscle Strength)
Muscle strength of participants were assessed with this device. Five repeated isokinetic muscle strength tests was performed at 180º / s angular velocity in order to determine the maximal muscle strength of the muscles of the lower limb M. Quadriceps femoris and Hamstring group.
Measured: 12 weeks
36-Item Short Form Survey (SF-36) (Quality of Life)
The Short Form 36 (SF-36) was standardized in 1990 as a self-report measure of functional health and well-being. Version 2.0 was published in 1996 (SF-36v2), with copyright and trademark privileges belonging to the Medical Outcomes Trust, Health Assessment Lab, and QualityMetric Incorporated. The SF-36 was designed to be a brief yet comprehensive measure of general health status. Likert scales and yes/no options are used to assess function and well-being on this 36-item questionnaire. To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales. The SF-36 has been translated into more than 40 languages.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start20 Nov 2017
- Primary completion20 Jun 2018
- Study completion20 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies 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
- Model description
- Randomized
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caner Karartı, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186143
- Sponsor's protocol ID
- 2019900
- Status last verified
- Jun 2020
- First submitted
- 30 Nov 2019
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Heywood S, McClelland J, Geigle P, Rahmann A, Villalta E, Mentiplay B, Clark R. Force during functional exercises on land and in water in older adults with and without knee osteoarthritis: Implications for rehabilitation. Knee. 2019 Jan;26(1):61-72. doi: 10.1016/j.knee.2018.11.003. Epub 2019 Jan 2.
PubMed 30611642Olagbegi OM, Adegoke BO, Odole AC. Effectiveness of three modes of kinetic-chain exercises on quadriceps muscle strength and thigh girth among individuals with knee osteoarthritis. Arch Physiother. 2017 Jul 19;7:9. doi: 10.1186/s40945-017-0036-6. eCollection 2017.
PubMed 29340203Resende RA, Kirkwood RN, Deluzio KJ, Morton AM, Fonseca ST. Mild leg length discrepancy affects lower limbs, pelvis and trunk biomechanics of individuals with knee osteoarthritis during gait. Clin Biomech (Bristol). 2016 Oct;38:1-7. doi: 10.1016/j.clinbiomech.2016.08.001. Epub 2016 Aug 3.
PubMed 27509479
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Closed and Open Kinetic Chain Exercises on Pain, Muscles Strength, Function, and Quality of Life In Patients With Knee Osteoarthritis In Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04186143
- Acronym / sponsor ID
- 2019900
- Conditions
- Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 4 Dec 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.
Osteoarthritis (OA) is a heterogeneous pathology characterized by focal cartilage degeneration and the formation of new bone around the subchondral bone and joint, which is the disruption of balance between the processes of destruction and repair in subchondral area. Knee OA is a considerable cause of disability and is present in 2-3% of all disability causes. Exercises are more noticeable than other methods because they are an easy method, low cost and long-lasting. To the best of our knowledge, the studies based on this topic are scarce. Therefore, the aim of this study was to compare the effects of open and closed kinetic chain exercises on pain, functional level, quality of life and muscle strength in patients with knee osteoarthritis.
Detailed description
Osteoarthritis (OA) is a heterogeneous pathology characterized by degeneration of the posterior focal cartilage and the formation of new bone around the subchondral bone and joint, which is the disruption of the balance between the processes of destruction and repair of the joint cartilage and subchondral region. Radiologically, OA was reported in the majority of people over 65 years old and in 80% of those over 75 years old. OA is the most common joint disease in the world. Knee OA is an important health problem due to pain, functional disability and reduced quality of life in patients. Studies have shown that knee OA is associated with inadequacy and pain associated with decreased quadriceps muscle strength. Strengthening education has been shown to have positive effects on OA.
Knee OA is a significant disability cause and is present in 3% of all disability causes. OA causes disability and consequent labor loss and economic loss. Therefore, OA therapy gains importance. OA therapy is classified under three headings as pharmacological methods, non-pharmacological methods and surgical methods. In non-pharmacological methods, there are a number of studies showing the effectiveness of exercise in particular. Because it is an easy method, the cost is low and it is applicable for a long time, the exercises are more important than other methods. The literature on exercise programs with optimal gains for knee osteoarthritis has not yet been established, with numerous studies reporting the importance of different types of exercise for the treatment of knee OA in the literature. Open kinetic chain exercises are frequently used to strengthen the quadriceps muscle. Closed kinetic chain exercises have been shown to increase muscle strength and improve proprioceptive function by activating more muscle spindle and joint proprioceptors. In literature, there are researches that compare closed and open kinetic chain exercises. However, these studies mostly focus on exercises after anterior cruciate ligament reconstruction. The aim of this study was to compare the effects of open and closed kinetic chain exercises on pain, functional level, quality of life and muscle strength in patients with knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Experimental-Study Group | Experimental | Other: Closed Cinetic Chain ExercisesIn addition to the conservative treatment of the control group, closed cinetic chain exercises were applied for 12 weeks. |
| Active Comparator | Active comparator | Other: Open Kinetic Chain ExercisesIn addition to the conservative treatment of the control group, opened cinetic chain exercises were applied for 12 weeks. |
| Control Group | Other | Other: Control GroupConservative treatment was applied for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- the presence of knee osteoarthritis Grade 2 and Grade 3 based on Kellgren Lawrence Classification,
- volunteering to participate in the study.
Key exclusion criteria (5 listed)
- the presence of active synovitis,
- participation physiotherapy program in the last 6 months,
- systemic and cardiovascular diseases,
- neurological and orthopedic problems affecting walking and standing,
- lower extremity surgery
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 |
|---|---|---|
| Closed Cinetic Chain ExercisesSit to stand, mini squat, anterior lunge, step up exercises are performed as Closed Cinetic Chain Exercises. | Other | Experimental-Study Group |
| Open Kinetic Chain ExercisesIsometric quadriceps, isotonic quadriceps, hip extension and hip adduction exercises are performed as Open Kinetic Chain Exercises. | Other | Active Comparator |
| Control GroupControl Group was followed up by conservative treatment and home program for 12 weeks and they were asked to apply the home program three days in a week. Exercise brochure was handed out for home program. Quadriceps strength and harmstring stretch exercises were applied. | Other | Control Group |
Primary outcome
Visual analogue scale (Pain)
Time frame: 12 weeks
The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. The 11-point numeric scale ranges from '0' representing no pain to '10' representing pain as bad as you can imagine or worst pain imaginable.
5 secondary outcomes
The WOMAC Index (Functional Level)
Time frame: 12 weeks
Biodex System Pro 4 Isokinetic Strength Dynamometer (Muscle Strength)
Time frame: 12 weeks
Biodex System Pro 4 Isokinetic Strength Dynamometer (Muscle Strength)
Time frame: 12 weeks
Biodex System Pro 4 Isokinetic Strength Dynamometer (Muscle Strength)
Time frame: 12 weeks
36-Item Short Form Survey (SF-36) (Quality of Life)
Time frame: 12 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 29 Jun 2020.
- Results publication: PubMed 30611642Heywood S, McClelland J, Geigle P, Rahmann A, Villalta E, Mentiplay B, Clark R. Force during functional exercises on land and in water in older adults with and without knee osteoarthritis: Implications for rehabilitation. Knee. 2019 Jan;26(1):61-72. doi: 10.1016/j.knee.2018.11.003. Epub 2019 Jan 2.
- Results publication: PubMed 29340203Olagbegi OM, Adegoke BO, Odole AC. Effectiveness of three modes of kinetic-chain exercises on quadriceps muscle strength and thigh girth among individuals with knee osteoarthritis. Arch Physiother. 2017 Jul 19;7:9. doi: 10.1186/s40945-017-0036-6. eCollection 2017.
- Results publication: PubMed 27509479Resende RA, Kirkwood RN, Deluzio KJ, Morton AM, Fonseca ST. Mild leg length discrepancy affects lower limbs, pelvis and trunk biomechanics of individuals with knee osteoarthritis during gait. Clin Biomech (Bristol). 2016 Oct;38:1-7. doi: 10.1016/j.clinbiomech.2016.08.001. Epub 2016 Aug 3.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed Cinetic Chain Exercises and Open Kinetic Chain Exercises in people with Osteo Arthritis Knee, 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 2 inclusion and 5 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 29 Jun 2020. 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?
Visual analogue scale (Pain) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04186143, which also lists 3 linked publications.
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 29 Jun 2020.