Osteoarthritis, KneeNCT04678609
OKV Versus CKC for Biomechanics and Function in Mild Knee OA Patients
A study testing Exercise in people with Osteoarthritis, Knee and Aging Problems, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
Background: Clinical recommendations suggest exercises as the core treatment for knee osteoarthritis (OA) patients. However, the biomechanical modification following exercise therapy and its influence on pain remains unclear. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Osteoarthritis, Knee, Aging Problems
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Aug 2020to 31 Dec 2022
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients
- aged above 50
- body mass index (BMI) <30 kg / m2
- diagnosed with grade I and II knee OA using Kellgren-Lawrence
- have knee pain ≥ 2 on a VAS in the past week
Who cannot join
- have neurological disorders
- have implanted electrical devices
- have non-ambulatory status
- have significant cognitive impairment
- presence of systemic inflammatory arthritis
- have history of hip or knee arthroplasty
Show all 12Show fewer
- have history of trauma or surgical arthroscopy of either knee in the last 6 months
- involved in a previous study that includes an exercise program within the last 6 months
- received a knee intra-articular injection within the last 3 months
- receives anticoagulant therapy
- have recent or imminent surgery within the last 3 months
- have any medical co-morbidities that excluding them from participation in exercises
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Universiti Sains Malaysia
Kota Bharu, Kelantan, 16150
Amran Ahmed Shokri, MBBS, 09-767 6373, amrankb@usm.my
About this study
Official title: Effects of Open and Closed Kinetic Chain Exercise on Functional Outcomes and Lower Limb Biomechanics in Mild Knee Osteoarthritis Patients
Background: Clinical recommendations suggest exercises as the core treatment for knee osteoarthritis (OA) patients. However, the biomechanical modification following exercise therapy and its influence on pain remains unclear. The purpose of the study to compare the effectiveness of two different exercise programs, open kinetic chain (CKC) and closed kinetic chain (CKC) strengthening exercises, on pain and lower limb biomechanics for people more than 50 years old with painful mild grade knee OA.
Method: 66 individuals with mild knee OA, with knee pain in the previous one week, aged 50 years and above, and who have body mass index (BMI) between 18.9kg/m2 - 29.9 kg/m2 in Kelantan, Malaysia will be recruited in this study. Participants will be randomly allocated into three different groups, either OKC, CKC, or control groups. Participants in OKC and CKC groups will perform the exercises at their home three times per week for eight weeks. The control group will receive only the patient's clinical education about clinical manifestations, risk factors, diagnosis, treatment, and nursing care for knee OA and printed materials will be given. The outcome will be measured before and after the intervention. Primary outcomes are self-reported pain, disability, and quality of life scores. Secondary outcomes include lower limb biomechanics during gait and sit-to-stand, and knee isokinetic strength.
Discussion: This study will compare the efficacy of two different home-based exercise intervention programs for people with mild grade knee OA. Findings will provide valuable information for creating an effective exercise program that could slow down the progression of OA.
Read the detailed description
The primary aim of this randomized controlled trial (RCT) is to compare the effects of two different home-based exercise programs namely OKC and CKC strengthening exercise intervention, on pain, disability, and quality of life on individuals with mild grade knee OA. Our secondary aim is to compare the effectiveness of OKC and CKC strengthening exercises on lower limb biomechanics during walking gait and sit to stand task. We hypothesize that after eight weeks of intervention OKC and CKC groups will show more improvements in pain, disability, and quality of life scores (what about the secondary outcomes) than the control group.
For the CKC and OKC exercise group, participants will perform an 8-week individualized home exercise, a minimum of three sessions in a week. Each session lasts about 30 minutes, including 5 minutes of walking as warming up session and quadriceps and hamstring stretching as the cooldown session. Daily Paracetamol 3000mg will be provided to all three groups. However, the consumption depends on each participant's needs, and the participants need to record it in the diary given. The exercise diary will be given to each participant to ensure patients' adherence to home exercise. During the intervention phase, a designated research team member will contact the participants personally to encourage them to continue their exercises.
The untreated control group received the patient's clinical education about clinical manifestations, risk factors, diagnosis, treatment, and nursing care for knee OA except the information related to exercise. The control group will not receive any home exercise guidance. Upon completing the trial, participants in the control group will receive either CKC or OKC exercises depending on their preference.
- Conditions
- Osteoarthritis, Knee, Aging Problems
- Being tested
- Exercise
- Keywords
- biomechanics, exercise
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
CKC: exercise with joints fixed on the ground OKC: exercise with joints not fixed on the ground
| Study group | Role | What they receive |
|---|---|---|
| Open kinetic chain exercise | Experimental | In the OKC exercise group, participants will be taught by a physiotherapist about open kinetic chain exercises. Then, they will do the exercises at their home for eight weeks, with three session per week. The physiotherapist will contact the participants to monitor their adherence to the intervention. A diary is also provided to monitor their progress, pain level and any adverse events related to the intervention. Receives: Other: Exercise |
| Closed kinetic chain exercise | Experimental | In the OKC exercise group, participants will be taught by a physiotherapist about open kinetic chain exercises. Then, they will do the exercises at their home for eight weeks, with three session per week. The physiotherapist will contact the participants to monitor their adherence to the intervention. A diary is also provided to monitor their progress, pain level and any adverse events related to the intervention. Receives: Other: Exercise |
| Control | No intervention | The untreated control group will receive patient's usual care of local government hospital which includes information about clinical manifestations, risk factors, diagnosis, treatment and nursing care for knee OA. Control group did not receive any home exercises guidance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of pain intensity score at post-intervention
pain intensity will be assessed using a visual analogue scale. It consists of a bidirectional 10-cm straight line, where 0 cm is "no pain" and 10 cm is "worst imaginable pain," located at either end of the line. Patients will be instructed to draw a vertical mark on the line indicating their pain level.
Measured: 8 weeks
Change from baseline of disability score at post-intervention
Western Ontario and McMaster Universities Arthritis Index consists of a number of questions designed to assess the clinical severity of the disease (5 questions for pain, 2 questions for stiffness and 17 questions for physical function). It includes 24 questions, each question scored using a five-point scale (0-4) with higher scores representing greater levels of pain, stiffness and severity of the disease. The overall score (index) is determined by summing the scores across the three dimensions and the score ranges between 0-96 (derived from a 0-4 Likert scale).
Measured: 8 weeks
Change from baseline of quality of life score at post-intervention
The Osteoarthritis Knee and Hip Quality of Life in Malay Version consists of 43 items divided into five dimensions: physical activity, mental health, pain, social support, and social functioning Each item in the five dimensions is measured on a numerical rating scale from 0 to 10. Each item is scored on a scale from 0 to 10, and the normalized scores were obtained by computing the sum of item scores for each domain and calculated to a scale from 0 (worst) to 100 (best) possible quality of life.
Measured: 8 weeks
Secondary outcomes (2)
Change from baseline of speed during gait at post-intervention
The time taken to complete a 6 metre platform will be determined before and after intervention. Faster speed indicates improve function.
Measured: 8 weeks
Change from baseline of knee adduction moment during gait at post-intervention
The knee adduction moment calculated from the vertical ground reaction force will be collected during mid-stance phase of gait. The value is in Newton metre and will be compared pre- and post-intervention. Reduced knee adduction moment indicates improved biomechanics.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Aug 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shazlin Shaharudin, Universiti Sains Malaysia
- Investigators
- Shazlin Shaharudin, PhD, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678609
- Sponsor's protocol ID
- USM/JEPeM/19100645
- Status last verified
- Apr 2021
- First submitted
- 11 Nov 2020
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All forms are anonymous and will be entered into SPSS software. Only research team members can access the data. Data will be presented as grouped data and will not identify the responders individually.
Publications
Ng WH, Jamaludin NI, Sahabuddin FNA, Ab Rahman S, Ahmed Shokri A, Shaharudin S. Comparison of the open kinetic chain and closed kinetic chain strengthening exercises on pain perception and lower limb biomechanics of patients with mild knee osteoarthritis: a randomized controlled trial protocol. Trials. 2022 Apr 15;23(1):315. doi: 10.1186/s13063-022-06153-8.
PubMed 35428274
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Open and Closed Kinetic Chain Exercise on Functional Outcomes and Lower Limb Biomechanics in Mild Knee Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT04678609
- Acronym / sponsor ID
- USM/JEPeM/19100645
- Conditions
- Osteoarthritis, Knee, Aging Problems
- Keywords
- biomechanics, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Dec 2020 (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.
Background: Clinical recommendations suggest exercises as the core treatment for knee osteoarthritis (OA) patients. However, the biomechanical modification following exercise therapy and its influence on pain remains unclear. The purpose of the study to compare the effectiveness of two different exercise programs, open kinetic chain (CKC) and closed kinetic chain (CKC) strengthening exercises, on pain and lower limb biomechanics for people more than 50 years old with painful mild grade knee OA.
Method: 66 individuals with mild knee OA, with knee pain in the previous one week, aged 50 years and above, and who have body mass index (BMI) between 18.9kg/m2 - 29.9 kg/m2 in Kelantan, Malaysia will be recruited in this study. Participants will be randomly allocated into three different groups, either OKC, CKC, or control groups. Participants in OKC and CKC groups will perform the exercises at their home three times per week for eight weeks. The control group will receive only the patient's clinical education about clinical manifestations, risk factors, diagnosis, treatment, and nursing care for knee OA and printed materials will be given. The outcome will be measured before and after the intervention. Primary outcomes are self-reported pain, disability, and quality of life scores. Secondary outcomes include lower limb biomechanics during gait and sit-to-stand, and knee isokinetic strength.
Discussion: This study will compare the efficacy of two different home-based exercise intervention programs for people with mild grade knee OA. Findings will provide valuable information for creating an effective exercise program that could slow down the progression of OA.
Detailed description
The primary aim of this randomized controlled trial (RCT) is to compare the effects of two different home-based exercise programs namely OKC and CKC strengthening exercise intervention, on pain, disability, and quality of life on individuals with mild grade knee OA. Our secondary aim is to compare the effectiveness of OKC and CKC strengthening exercises on lower limb biomechanics during walking gait and sit to stand task. We hypothesize that after eight weeks of intervention OKC and CKC groups will show more improvements in pain, disability, and quality of life scores (what about the secondary outcomes) than the control group.
For the CKC and OKC exercise group, participants will perform an 8-week individualized home exercise, a minimum of three sessions in a week. Each session lasts about 30 minutes, including 5 minutes of walking as warming up session and quadriceps and hamstring stretching as the cooldown session. Daily Paracetamol 3000mg will be provided to all three groups. However, the consumption depends on each participant's needs, and the participants need to record it in the diary given. The exercise diary will be given to each participant to ensure patients' adherence to home exercise. During the intervention phase, a designated research team member will contact the participants personally to encourage them to continue their exercises.
The untreated control group received the patient's clinical education about clinical manifestations, risk factors, diagnosis, treatment, and nursing care for knee OA except the information related to exercise. The control group will not receive any home exercise guidance. Upon completing the trial, participants in the control group will receive either CKC or OKC exercises depending on their preference.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open kinetic chain exercise | Experimental | Other: ExerciseIn the OKC exercise group, participants will be taught by a physiotherapist about open kinetic chain exercises. Then, they will do the exercises at their home for eight weeks, with three session per week. The physiotherapist will contact the participants to monitor their adherence to the intervention. A diary is also provided to monitor their progress, pain level and any adverse events related to the intervention. |
| Closed kinetic chain exercise | Experimental | Other: ExerciseIn the OKC exercise group, participants will be taught by a physiotherapist about open kinetic chain exercises. Then, they will do the exercises at their home for eight weeks, with three session per week. The physiotherapist will contact the participants to monitor their adherence to the intervention. A diary is also provided to monitor their progress, pain level and any adverse events related to the intervention. |
| Control | No intervention | –The untreated control group will receive patient's usual care of local government hospital which includes information about clinical manifestations, risk factors, diagnosis, treatment and nursing care for knee OA. Control group did not receive any home exercises guidance. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- female patients
- aged above 50
- body mass index (BMI) <30 kg / m2
- diagnosed with grade I and II knee OA using Kellgren-Lawrence
- have knee pain ≥ 2 on a VAS in the past week
Key exclusion criteria (12 listed)
- have neurological disorders
- have implanted electrical devices
- have non-ambulatory status
- have significant cognitive impairment
- presence of systemic inflammatory arthritis
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 |
|---|---|---|
| ExerciseCKC: exercise with joints fixed on the ground OKC: exercise with joints not fixed on the ground | Other | Closed kinetic chain exercise, Open kinetic chain exercise |
Primary outcome
Change from baseline of pain intensity score at post-intervention
Time frame: 8 weeks
pain intensity will be assessed using a visual analogue scale. It consists of a bidirectional 10-cm straight line, where 0 cm is "no pain" and 10 cm is "worst imaginable pain," located at either end of the line. Patients will be instructed to draw a vertical mark on the line indicating their pain level.
Change from baseline of disability score at post-intervention
Time frame: 8 weeks
Western Ontario and McMaster Universities Arthritis Index consists of a number of questions designed to assess the clinical severity of the disease (5 questions for pain, 2 questions for stiffness and 17 questions for physical function). It includes 24 questions, each question scored using a five-point scale (0-4) with higher scores representing greater levels of pain, stiffness and severity of the disease. The overall score (index) is determined by summing the scores across the three dimensions and the score ranges between 0-96 (derived from a 0-4 Likert scale).
Change from baseline of quality of life score at post-intervention
Time frame: 8 weeks
The Osteoarthritis Knee and Hip Quality of Life in Malay Version consists of 43 items divided into five dimensions: physical activity, mental health, pain, social support, and social functioning Each item in the five dimensions is measured on a numerical rating scale from 0 to 10. Each item is scored on a scale from 0 to 10, and the normalized scores were obtained by computing the sum of item scores for each domain and calculated to a scale from 0 (worst) to 100 (best) possible quality of life.
2 secondary outcomes
Change from baseline of speed during gait at post-intervention
Time frame: 8 weeks
Change from baseline of knee adduction moment during gait at post-intervention
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Derived from this study: PubMed 35428274Ng WH, Jamaludin NI, Sahabuddin FNA, Ab Rahman S, Ahmed Shokri A, Shaharudin S. Comparison of the open kinetic chain and closed kinetic chain strengthening exercises on pain perception and lower limb biomechanics of patients with mild knee osteoarthritis: a randomized controlled trial protocol. Trials. 2022 Apr 15;23(1):315. doi: 10.1186/s13063-022-06153-8.
- Individual participant dataSharing planned: No. All forms are anonymous and will be entered into SPSS software. Only research team members can access the data. Data will be presented as grouped data and will not identify the responders individually.
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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.
Shazlin Shaharudin, PhD principal investigator
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Osteoarthritis, Knee and Aging Problems, run by Universiti Sains Malaysia at 1 site in Malaysia.
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 12 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: status not confirmed, as of the sponsor's last update on 20 Apr 2021. 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 Malaysia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohd Bazlan Hafidz Mukrim, BSc (+609-767 2364, jepem@usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of pain intensity score at post-intervention (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 NCT04678609, which also lists 1 linked publication.
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 20 Apr 2021.