A Novel, Theory Based Intervention to Promote Engagement in Physical Activity in Early Rheumatoid Arthritis (PEPA-RA): Proof of Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Intervention Attendance
研究概览
简要总结
People with rheumatoid arthritis have indicated that they would like better support to remain physically active following diagnosis and would welcome a physical activity programmes delivered outside of a secondary care setting by a physiotherapist. With patient input, and based upon previous research in other long term conditions, a physical activity intervention was developed by the researchers for delivery by musculoskeletal physiotherapists in a primary care setting.
This proposed proof of concept study will investigate the new intervention and inform a future randomised controlled pilot trial. Four Band 6 musculoskeletal physiotherapists will be trained to deliver the intervention. Subsequently up to 32 patients with a recent diagnosis of rheumatoid arthritis (6 -24 months previously) will be recruited. Each physiotherapist will deliver the 12-week intervention package to a group of 6-8 participants. The participants will be asked to complete some outcome measures at the beginning of the 12-week intervention and again at the end.
Following the 12-week programme some of the patients will be asked what they thought of the programme and the outcome measures and whether they have any suggestions for improvement. Those that did and did not complete the programme will be included to ensure a wide range of views. The treating physiotherapists will also be asked about their experiences of delivering the programme as well as what they thought of the training.
Based upon these findings the programme will be refined and if appropriate further funding sought to carry out a pilot randomised controlled trial.
详细描述
A novel, theory based intervention to promote engagement in physical activity in early rheumatoid arthritis (PEPA-RA): proof of concept study.
People with rheumatoid arthritis (RA) do less physical activity (PA) than the general population and this is associated with work disability and reduced physical function. High intensity training and supervised exercise can improve physical function in RA, while PA decreases chronic inflammation and reduces pain, all without adversely affecting disease activity. Despite the benefits, patients do not maintain exercise beyond the supervised intervention and benefits are not maintained.
People with RA report a range of barriers to PA and are often reluctant to participate for fear of exacerbating their symptoms. It is therefore essential that they are provided with appropriate support to overcome these barriers soon after diagnosis, in order to optimise PA, minimise inappropriate health beliefs and prevent unnecessary reductions in function. Patients have also expressed a desire for more information relating to exercise.
Physiotherapists are best placed to provide this support as their approach is person-centred, taking into account the individual's health and wellbeing needs and supporting self-management through patient education and the facilitation of behaviour change. Whilst the National Institute for Health and Care Excellence (NICE) guidelines indicate that people with RA should have access to specialist physiotherapy to encourage regular PA this rarely occurs in practice with a third of patients waiting over a year for physiotherapy. The British Society of Rheumatology suggests that conversations regarding health promotion, including PA, need to occur early in the patient pathway and are best delivered via primary care.
To explore the opinions of people with RA in relation to support for PA programmes the investigators carried out focus groups. Based upon these findings, in combination with existing evidence and input from patient research partners, the researchers designed an intervention for delivery in a primary care setting for people with recently diagnosed RA. The focus group participants were in agreement that the intervention should be delivered in an accessible location within their local community. The intervention is informed by a theoretical framework for health behaviour change. The overall purpose of this new intervention is to support long term engagement with PA in order to optimise maintenance of physical function. The researchers plan to investigate the effectiveness of the intervention in a future trial, but initially need to carry out a proof of concept study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with RA diagnosed in the previous 6-24 months. Able to undertake a PA programme. Able to understand and speak English. Able to understand the purpose of the research Provides informed consent.
排除标准
- •Diagnosis of RA less than 6 months or more than 2 years previously. Unable to participate for medical reasons.
结局指标
主要结局
Intervention Attendance
时间窗: 12 weeks
minimum 0 maximum 5; higher is better
次要结局
- Bristol Rheumatoid Arthritis Fatigue - Numerical Rating Scales(7 days)
- International Physical Activity Questionnaire - Short Form(7 days)
- Self-efficacy for Exercise(7-days)
- 6-minute walk distance(6 minutes)
- Generic quality of life: EuroQoL - EQ-5D-5L(day of completion)
- Short Form 12(4 weeks)
- modified Health Assessment Questionnaire(7 days)
- Motivation to exercise: Behavioural Regulation In Exercise Questionnaire version 2(7-days)
