Clinical trial NCT02734342: Mixed Methods Assessment of Exercises for Knee OA
Official title: Mixed Methods Study to Evaluate Pain, Function, Postural Stabilisation, and Fear of Movement Following a Lower Limb Exercise Programme for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University of Salford
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 44
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

* 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.

Primary outcomes:
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.
timeFrame: At the beginning, through study completion, an average 10 weeks.
Secondary outcomes:
measure: Change in the level of psychological and functional relationships using the Y balance test during an exercises programme and 6 weeks after the programme.
timeFrame: At the beginning, through study completion, an average 10 weeks.
measure: Change in the understanding of key factors that patients think about exercise as an intervention using a semistructured interview.
timeFrame: 6 weeks post exercise class
Other outcomes:
measure: Change in the level of function, pain,quality of life, sport and recreation, activities of daily living and symptoms in patients during an exercise programme and 6 weeks after the programme.
timeFrame: At the beginning, through study completion, an average 10 weeks.
measure: Change in the level of physical activity during an exercise programme and 6 weeks after the programme.
timeFrame: At the beginning, through study completion, an average 10 weeks.
measure: Change in the distance walked within a 6 minute period during an exercise programme and 6 weeks after the programme.
timeFrame: At the beginning, through study completion, an average 10 weeks.
measure: Change in the level of pain intensity during an exercise programme and 6 weeks after the programme.
timeFrame: At the beginning, through study completion, an average 10 weeks.
measure: Change in the level of perceived exertion during an exercise programme .
timeFrame: At the beginning, through study completion, an average 4 weeks.
measure: Change in the level of physical activity during an exercise programme and 6 weeks after the programme.
timeFrame: At the beginning and 6 weeks after the exercise programme.
measure: Change in the level of lower extremity functional strength during an exercise programme and 6 weeks after the programme.
timeFrame: At the beginning, through study completion, an average 10 weeks.
Locations:
city: Leigh
country: United Kingdom
facility: Bridgewater Community Healthcare Foundation Trust
Study officials:
References:
citation: 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.