Knee OsteoarthritisNCT02734342
Mixed Methods Assessment of Exercises for Knee OA
A study testing exercise in people with Knee Osteoarthritis, run by University of Salford at 1 site in United Kingdom.
Trial summary
Osteoarthritis (OA) is a condition that causes cartilage loss, bony remodeling, joint stiffness and generalized muscle weakness. 90% of OA presentation has been reported within the leg; with 44% affecting the knee joint. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2016to Apr 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must elicit 3 of the 6 symptoms to be included:
- forty five years of age and over.
- stiffness for less than thirty minutes;
- crepitus;
- bony tenderness;
- bony enlargement;
- no palpable joint warmth.
Who cannot join
- previous lower limb joint injection within three months;
- previous hip or knee joint replacement;
- any severe cognitive, cardio- respiratory, musculoskeletal or neurological - diagnosis that prevents participants from exercising;
- insoles or braces;
- ligament instability;
- participants with a body mass index (BMI) over 40 will be issued with a choice of completing in the study or being managed by the National Health Service weight management service;
- other minor health related issues will be assessed prior to the commencement of the study to ensure safe practice.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Bridgewater Community Healthcare Foundation Trust
Leigh, wn7 1hs
Jimmy Molyneux, MSc, 01942 483413, j.molyneux1@edu.salford.ac.uk
Richard Jones, Professor, 0161 295 2295, r.k.jones@salford.ac.uk
About this study
Official title: Mixed Methods Study to Evaluate Pain, Function, Postural Stabilisation, and Fear of Movement Following a Lower Limb Exercise Programme for Knee Osteoarthritis
Osteoarthritis (OA) is a condition that causes cartilage loss, bony remodeling, joint stiffness and generalized muscle weakness. 90% of OA presentation has been reported within the leg; with 44% affecting the knee joint. Knee OA is expected to increase by 50% over the next twenty years due to an ageing population, obesity, and societal trends such as lack of activity. Only 13% of knee OA sufferers reach the recommended levels of exercise therefore an understanding of how psychological and functional relationships effect exercise engagement, which in turn would provide a more comprehensive rehabilitation programme for patients with knee OA. The aim of this study is to investigate exercise in knee OA and it it's correlation with fear of movement, using a mixed methods approach. Quantitative methodology will investigate lower limb exercises for pain and function and fear of movement. The desired outcome of the study will show that a reduction in pain with patient specific exercise will also reduce the fear of movement and allow patients to self-manage their symptoms without fear. Other quantitative factors such as intensity of exercise and postural stabilization using the Y balance test will also be utilized to review the functional relationship of muscle strength and balance to kinesiophobia. A semi-structured interview will be completed at the end of the course of treatment to highlight what patients think about exercise as an intervention. Participants aged forty-five and above with specific clinical symptoms will be invited into the study and will be asked to attend eight exercise sessions within a class environment, which will last for 1 hour within the Physiotherapy Department.
Read the detailed description
Exercise is recommended for the treatment for knee osteoarthritis (OA) with muscle strength and aerobic exercise improving physical function. There is evidence supporting quadriceps strength for patients with painful knee OA; positive effects on pain; and general fitness.
Research reviews by suggest exercise as an important aspect of rehabilitation in knee OA. However, there is very limited evidence to what type of exercises actually decrease pain and improve activity.
Despite positive evidence regarding exercise, highlighted major issues within the United Kingdom with only 5% of people with knee OA achieving the recommended level of activity and 57% of the population not completing regular exercise. 1% to 4% of total healthcare costs account for physical inactivity which cost 8.3 billion in 2009.
An essential factor of physical inactivity is exercise behaviour. Fear of movement is an important aspect of knee OA. Disability is present due to the individual's fear of physical movements that would cause pain. Evidence links fear of movement with knee OA and the role of exercise in the management of knee OA. Patients with OA experience pain during activity, which leads to an expectation that further activity, will cause greater pain therefore increasing muscle weakness. It has been indicated that individuals could have negative attitudes and beliefs about their knee problems, which could cause a barrier to treatment, with socioeconomic, personality and environmental factors being as important as the physical characteristics. Other factors such as balance issues and laxity of the knee have been associated with activity limitations. However, in a systematic review found weak evidence to support pain, distress, and avoidance of activity in participants with knee OA. Understanding individual exercise behaviours and habits is essential to improve exercise adherence. Non-compliance is common within physiotherapy with patients unwilling to accommodate exercises within everyday life. Reasons for this may include type of exercises, dosage, and underlying beliefs from the clinicians towards exercise as well as external factors. Incorrect prescription of exercises can lead to increased pain, decreased function and decreased exercise adherence. This could cause fear of movement whilst completing exercise. It has been concluded that in OA there is limited evidence that interventions can improve exercise adherence. Therefore, an understanding of non-adherence and the effects of kinesiophobia is essential to further develop exercise programmes for patients with OA.
- Conditions
- Knee Osteoarthritis
- Being tested
- exercise
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
Participants will be asked to attend eight exercise sessions within a group class environment that will last for 1 hour. The exercise programme has been developed through clinical and research evidence. During the hour, a 5 minute warm up followed by 14 exercises specific to strengthening the lower limb and improving aerobic capacity. Each exercise will be timed for two minutes with the participant reporting number of repetitions counted. A cool down will be completed at the end of the class. After each exercise class, the participant will be advised to have a recovery day to prevent overloading (De Carlo \& Armstrong, 2010). Progression of exercises will be patient led. Participants will attend twice per week for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise, Kinesiophobia and Knee Osteoarthritis | Experimental | Participants will be asked to attend eight exercise sessions within a group class environment that will last for 1 hour. During the hour, participants will complete a 5 minute warm up followed by 14 exercises specific to strengthening the lower limb and improve aerobic capacity. Each exercise will be timed for two minutes with the participant reporting number of repetitions counted. Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the level of kinesiophobia with exercise assessed using the Tampa Kinesiophobia Scale during an exercise programme and 6 weeks after the programme.
Patients will be asked to complete the Tampa Kinesiophobia Scale at the beginning of the study, before exercise session 4, before session 8 and 6 weeks after the exercise programme. This will measure the level of kinesiophobia associated with exercise. If an individual scores highly, this indicates a high level of kinesiophobia.
Measured: At the beginning, through study completion, an average 10 weeks.
Secondary outcomes (2)
Change in the level of psychological and functional relationships using the Y balance test during an exercises programme and 6 weeks after the programme.
The Y balance test is a quick, efficient, objective, portable, and consistent tool and will be used to evaluate dynamic and asymmetrical balance whilst utilising muscle strength and flexibility at the hip, knee and ankle joints. It consists of a stance platform to which three pieces of plastic pipe are attached in the three reach directions; anterior (ANT), posteromedial (PM), and posterolateral (PL). The PM and PL pipes are positioned 135 degrees from the ANT pipe with 45 degrees between the posterior pipes. The pipes are marked at 5 mm intervals for measurement. To perform the test the subject pushes the reach indicator along each of the pipes and a score is calculated. Each leg will be tested.
Measured: At the beginning, through study completion, an average 10 weeks.
Change in the understanding of key factors that patients think about exercise as an intervention using a semistructured interview.
A semi-structured interview will be completed at the end of course of treatment to highlight what patients think about exercise as an intervention.
Measured: 6 weeks post exercise class
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (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 Knee OsteoarthritisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jimmy Molyneux, University of Salford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734342
- Sponsor's protocol ID
- IRAS ID 154227
- Status last verified
- May 2016
- First submitted
- 15 Feb 2016
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The results of the study will form part of the researcher's doctoral thesis and may be published anonymously in professional journals and/or as conference presentations.
Publications
Molyneux J, Herrrington L, Riley B, Jones R. A single-arm, non-randomized investigation into the short-term effects and follow-up of a 4-week lower limb exercise programme on kinesiophobia in individuals with knee osteoarthritis. Physiother Res Int. 2020 Jul;25(3):e1831. doi: 10.1002/pri.1831. Epub 2020 Jan 24.
PubMed 31975503
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mixed Methods Study to Evaluate Pain, Function, Postural Stabilisation, and Fear of Movement Following a Lower Limb Exercise Programme for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02734342
- Acronym / sponsor ID
- IRAS ID 154227
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of SalfordUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 12 Apr 2016 (estimated)
- 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 condition that causes cartilage loss, bony remodeling, joint stiffness and generalized muscle weakness. 90% of OA presentation has been reported within the leg; with 44% affecting the knee joint. Knee OA is expected to increase by 50% over the next twenty years due to an ageing population, obesity, and societal trends such as lack of activity. Only 13% of knee OA sufferers reach the recommended levels of exercise therefore an understanding of how psychological and functional relationships effect exercise engagement, which in turn would provide a more comprehensive rehabilitation programme for patients with knee OA. The aim of this study is to investigate exercise in knee OA and it it's correlation with fear of movement, using a mixed methods approach. Quantitative methodology will investigate lower limb exercises for pain and function and fear of movement. The desired outcome of the study will show that a reduction in pain with patient specific exercise will also reduce the fear of movement and allow patients to self-manage their symptoms without fear. Other quantitative factors such as intensity of exercise and postural stabilization using the Y balance test will also be utilized to review the functional relationship of muscle strength and balance to kinesiophobia. A semi-structured interview will be completed at the end of the course of treatment to highlight what patients think about exercise as an intervention. Participants aged forty-five and above with specific clinical symptoms will be invited into the study and will be asked to attend eight exercise sessions within a class environment, which will last for 1 hour within the Physiotherapy Department.
Detailed description
Exercise is recommended for the treatment for knee osteoarthritis (OA) with muscle strength and aerobic exercise improving physical function. There is evidence supporting quadriceps strength for patients with painful knee OA; positive effects on pain; and general fitness.
Research reviews by suggest exercise as an important aspect of rehabilitation in knee OA. However, there is very limited evidence to what type of exercises actually decrease pain and improve activity.
Despite positive evidence regarding exercise, highlighted major issues within the United Kingdom with only 5% of people with knee OA achieving the recommended level of activity and 57% of the population not completing regular exercise. 1% to 4% of total healthcare costs account for physical inactivity which cost 8.3 billion in 2009.
An essential factor of physical inactivity is exercise behaviour. Fear of movement is an important aspect of knee OA. Disability is present due to the individual's fear of physical movements that would cause pain. Evidence links fear of movement with knee OA and the role of exercise in the management of knee OA. Patients with OA experience pain during activity, which leads to an expectation that further activity, will cause greater pain therefore increasing muscle weakness. It has been indicated that individuals could have negative attitudes and beliefs about their knee problems, which could cause a barrier to treatment, with socioeconomic, personality and environmental factors being as important as the physical characteristics. Other factors such as balance issues and laxity of the knee have been associated with activity limitations. However, in a systematic review found weak evidence to support pain, distress, and avoidance of activity in participants with knee OA. Understanding individual exercise behaviours and habits is essential to improve exercise adherence. Non-compliance is common within physiotherapy with patients unwilling to accommodate exercises within everyday life. Reasons for this may include type of exercises, dosage, and underlying beliefs from the clinicians towards exercise as well as external factors. Incorrect prescription of exercises can lead to increased pain, decreased function and decreased exercise adherence. This could cause fear of movement whilst completing exercise. It has been concluded that in OA there is limited evidence that interventions can improve exercise adherence. Therefore, an understanding of non-adherence and the effects of kinesiophobia is essential to further develop exercise programmes for patients with OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise, Kinesiophobia and Knee Osteoarthritis | Experimental | Other: exerciseParticipants will be asked to attend eight exercise sessions within a group class environment that will last for 1 hour. During the hour, participants will complete a 5 minute warm up followed by 14 exercises specific to strengthening the lower limb and improve aerobic capacity. Each exercise will be timed for two minutes with the participant reporting number of repetitions counted. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- forty five years of age and over.
- stiffness for less than thirty minutes;
- crepitus;
- bony tenderness;
- bony enlargement;
Key exclusion criteria (7 listed)
- previous lower limb joint injection within three months;
- previous hip or knee joint replacement;
- any severe cognitive, cardio- respiratory, musculoskeletal or neurological - diagnosis that prevents participants from exercising;
- insoles or braces;
- ligament instability;
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 |
|---|---|---|
| exerciseParticipants will be asked to attend eight exercise sessions within a group class environment that will last for 1 hour. The exercise programme has been developed through clinical and research evidence. During the hour, a 5 minute warm up followed by 14 exercises specific to strengthening the lower limb and improving aerobic capacity. Each exercise will be timed for two minutes with the participant reporting number of repetitions counted. A cool down will be completed at the end of the class. After each exercise class, the participant will be advised to have a recovery day to prevent overloading (De Carlo \& Armstrong, 2010). Progression of exercises will be patient led. Participants will attend twice per week for four weeks. | Other | Exercise, Kinesiophobia and Knee Osteoarthritis |
Primary outcome
Change in the level of kinesiophobia with exercise assessed using the Tampa Kinesiophobia Scale during an exercise programme and 6 weeks after the programme.
Time frame: At the beginning, through study completion, an average 10 weeks.
Patients will be asked to complete the Tampa Kinesiophobia Scale at the beginning of the study, before exercise session 4, before session 8 and 6 weeks after the exercise programme. This will measure the level of kinesiophobia associated with exercise. If an individual scores highly, this indicates a high level of kinesiophobia.
2 secondary outcomes
Change in the level of psychological and functional relationships using the Y balance test during an exercises programme and 6 weeks after the programme.
Time frame: At the beginning, through study completion, an average 10 weeks.
Change in the understanding of key factors that patients think about exercise as an intervention using a semistructured interview.
Time frame: 6 weeks post exercise class
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
- Derived from this study: PubMed 31975503Molyneux J, Herrrington L, Riley B, Jones R. A single-arm, non-randomized investigation into the short-term effects and follow-up of a 4-week lower limb exercise programme on kinesiophobia in individuals with knee osteoarthritis. Physiother Res Int. 2020 Jul;25(3):e1831. doi: 10.1002/pri.1831. Epub 2020 Jan 24.
- Individual participant dataSharing planned: Yes. The results of the study will form part of the researcher's doctoral thesis and may be published anonymously in professional journals and/or as conference presentations.
Related trials for Knee Osteoarthritis
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain
Osteoarthritis, Knee, Chronic Pain
Not yet recruiting
EFFECT OF ADDING BLOOD FLOW RESTRICTION TRAINING TO CLOSED CHAIN EXERCISE IN KNEE OSTEOARTHRITIS
Knee Osteoarthritis
Not yet recruiting
Platelet-Rich Plasma, Hyaluronic Acid, or Their Combination for Knee Osteoarthritis in Athletes
Knee Osteoarthritis
Recruiting
Study NRPT Feasibility in Knee Osteoarthritis
Knee Osteoarthristis
Recruiting
Unipolar Versus Bipolar Radiofrequency Ablation in Knee Osteoarthritis Pain
Bipolar Radiofrequency Ablation, Unipolar Radiofrequency Ablation
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.
Bridgewater Community Healthcare Foundation Trust
Leigh, United Kingdom
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 Knee Osteoarthritis, run by University of Salford at 1 site in United Kingdom.
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 7 inclusion and 7 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 24 May 2016. 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 United Kingdom. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the level of kinesiophobia with exercise assessed using the Tampa Kinesiophobia Scale during an exercise programme and 6 weeks after the programme. (time frame: At the beginning, through study completion, an average 10 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 NCT02734342, 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 24 May 2016.