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Staying active with physiotherapy in patients with osteoarthritis

STaying Active with Physiotherapy in patients with Lower-limb Osteoarthritis (STAPLO): Feasibility Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12002764
Enrollment
45
Registered
2022-02-15
Start date
2022-03-14
Completion date
Unknown
Last updated
2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis Musculoskeletal Diseases Arthrosis, unspecified

Interventions

The study uses a single group of up to 35 patients with lower-limb OA. They will complete written and some functional outcome measures before treatment and 3 and 6 months later. The researchers are ai

Sponsors

University of Birmingham
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of unilateral or bilateral lower-limb osteoarthritis (OA) based on the NICE guidelines 2. Males or females =45 years of age 3. Morning joint-related stiffness lasting =30 minutes or no morning joint-related stiffness 4. Activity-related joint pain

Exclusion criteria

Exclusion criteria: 1. A further joint-related pathology that could affect the biomechanics of the hip or knee e.g. rheumatoid arthritis or lumbar nerve root lesion 2. Previously had or awaiting knee or hip joint replacement 3. Wheelchair dependent 4. Unwilling/unable to give informed consent for treatment 5. Unable to communicate fluently in English 6. Diagnosed with a psychiatric illness (e.g. schizophrenia) 7. Diagnosed with an upper motor neurone lesion e.g. multiple sclerosis 8. Unwilling/unable to attend physiotherapy sessions

Design outcomes

Primary

MeasureTime frame
The feasibility of conducting an RCT using the behaviour change intervention, established through descriptive statistics and qualitative analysis of participants' and physiotherapists' perceptions of the intervention and trial-related queries. Descriptive statistics will be inputted iteratively and analysed at the end of the trial. Interviews with people with lower-limb osteoarthritis will occur after they have been discharged from care (approximately 4 months post-baseline). Focus groups of physiotherapist and research staff will take place at the end of the trial (approximately 15 months from the trial commencing).

Secondary

MeasureTime frame
As part of the trial, outcomes that are intended for use in the RCT will be collected (to test the feasibility of outcome assessment): 1. Physical activity measured using an actigraph 9 accelerometer at baseline, 3 and 6 months 2. Physical activity measured using the Short-Form (7-questions) International Physical Activity Questionnaire at baseline, 3 and 6 months 3. Adherence to physical activity/exercise recommendations measured using Section B of The Exercise Adherence Rating Scale (6 Items) at baseline, 3 and 6 months 4. Pain measured using the 11-point Numerical Pain Rating Scale at baseline, 3 and 6 months 5. Function measured using the self-report Short form Hip Disability and Osteoarthritis Outcome Score (SF-HOOS)/Short-From Knee Injury and Osteoarthritis Outcome Score (SF-KOOS) at baseline, 3 and 6 months 6. Function measured using the 5 times sit-stand test and the figure of 8 walking test at baseline, 3 and 6 months 7. Bothersomeness measured using the Bothersomeness Index: 5-point Likert scale at baseline, 3 and 6 months 8. Quality of life measured using the EuroQol 5-domain instrument (EQ-5D) at baseline, 3 and 6 months 9. Self-efficacy for physical activity/exercise measured using the Self-Efficacy for Exercise Scale 9-items at baseline, 3 and 6 months 10. Motivation regulations to participate in physical activity/exercise measured using the Behavioural Regulation in Exercise Questionnaire-3 24-Items at baseline, 3 and 6 months 11. Psychological needs satisfaction measured using a modified version of the Psychological Need Satisfaction in Exercise Scale at baseline, 3 and 6 months 12. Social psychological environment/ perceptions of autonomy support measured using the Health Care Climate Questionnaire 15-items at 3 months post baseline

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026