Mixed Methods Assessment of Exercises for Knee OA

NCT02734342 | Unknown DMC

• 1 other identifier: IRAS ID 154227
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  6 weeks post exercise class

Other Outcomes (7)

• 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.

  At the beginning, through study completion, an average 10 weeks.

• Change in the level of physical activity during an exercise programme and 6 weeks after the programme.

  At the beginning, through study completion, an average 10 weeks.

• Change in the distance walked within a 6 minute period during an exercise programme and 6 weeks after the programme.

  At the beginning, through study completion, an average 10 weeks.

Study Arms (1)

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.

Other: exercise

Interventions

exercise OTHER

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.

Exercise, Kinesiophobia and Knee Osteoarthritis

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salford: lead

Study Sites (1)

Bridgewater Community Healthcare Foundation Trust

Leigh, wn7 1hs, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 31975503 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: April 12, 2016
• Study Start: February 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 24, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)