Can a Brief Behavioural Assessment Improve Exercise Adherence in Older People With Musculoskeletal Conditions: A Feasibility Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Self-reported Adherence
研究概览
简要总结
Exercise is an effective treatment modality for many chronic conditions. The effectiveness of prescribed exercise can be limited by adherence to exercise programmes. Older people are more likely to have a long term, or multiple long term conditions, for which exercise is a treatment option. The investigators know that exercise engagement after discharge from hospital or physiotherapy is poor in older people. In addition to this there may be specific factors that affect exercise adherence in older people. Exercise adherence interventions can be viewed as behaviour change interventions, as their aim is to change the behaviour of the patient. However many interventions lack theoretical underpinning. This study will test the feasibility of a brief behavioural assessment underpinned by the COM-B behaviour change model, in addition to targeted adherence approaches based on that assessment. Participants will be randomised between usual care, and the behavioural assessment intervention arm. Adherence to the exercise programme given in physiotherapy will be recorded in both groups at 6 and 12 weeks. Feasibility of recruitment, retention and acceptability of the intervention will also be assessed. A subsection of participants will also take part in a qualitative interview, this will explore participants experience of the trial intervention, in addition to the participants experience of attempting to adhere to an exercise programme.
详细描述
The design of this study, is a a two arm feasibility randomised controlled trial. Participants will be randomised between usual care, or the intervention arm which will consist of a brief behavioural assessment and recommended adherence strategies based on the outcome of the assessment. A sub sample of the population will undergo a qualitative interview to assess acceptability of the intervention
Potential research participants will be invited to take part in the study with an invitation letter, along with the PIS and a reply slip. These will be sent out with information about their physiotherapy appointment, which they would normally receive.
After time to consider the study and ask any questions, if participants are happy to take part, an appointment will be made to take consent and collect baseline measures. This will take place at the Nuffield Orthopaedic Centre, if possible just prior to their physiotherapy appointment in order to limit disturbance to the participant. If this is not possible the appointment to collect consent and baseline data will be at a time convenient to the patient. At this appointment, signed consent will be recorded and baseline data collected. This will involve the participants completing some questionnaires.
Treatment allocation will be decided on the basis of the physiotherapist the participant is seeing. (Before the start of the study all physiotherapist taking part in the study will be randomly assigned to deliver either usual care or the intervention arm). Those participants in usual care will undergo physiotherapy as normal, the only additional thing they will be asked to do, is to complete an exercise diary for up to 12 weeks.
Those in the intervention arm will be asked to complete 4 short questions related to exercise and treatment expectations. These will be completed in the waiting room prior to the physiotherapy appointment. The participant will be assessed and given treatment as normal in physiotherapy. After they have been given an exercise programme as part of their treatment, they will be asked to complete a further 7 short questions related to the exercise programme, and their motivation and intention to undertake it. On the basis of the answers to these questions and also in addition to any discussion with the physiotherapists, one or more adherence approaches may be suggested. The approaches are 'review of exercise programme', 'review of method of delivery', 'cues', 'reminders', 'discussion of barriers and problem solving', 'motivational interviewing', 'decision balance sheets', 'behavioural contract' and 'goal setting review'. The participants in the intervention group will also be asked to complete an exercise diary for up to 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the study
- •Male or Female, aged 65 years or above
- •Referred to physiotherapy with a musculoskeletal problem
- •Able to converse in and read English
排除标准
- •Any comorbidity that precludes exercising such as unstable angina, or acute illness
- •Dementia or cognitive impairment precluding the ability to follow an exercise programme
- •Patients referred to physiotherapy for post-surgery rehabilitation
研究组 & 干预措施
Usual care
The usual care arm will consist of routine physiotherapy treatment, without the intervention.
干预措施: Usual Care (Behavioral)
Exercise adherence intervention
The intervention arm will consist of a brief behavioural assessment and recommended adherence strategies based on the outcome of the assessment.
干预措施: Exercise adherence intervention (Behavioral)
结局指标
主要结局
Self-reported Adherence
时间窗: 12 weeks
This is a self-report scale ranging from 0-10, where patient will be asked to rate their adherence over the previous twelve weeks, ranging from 0 = 'no exercises performed' to 10 = 'all exercise performed as instructed'
次要结局
- Exercise Adherence Rating Scale (EARS)(6 weeks and 12 weeks)
- Exercise Diary(12 weeks)
- Global Rating of Change(6 weeks and 12 weeks)
- Physical Activity Scale for the Elderly (PASE)(6 weeks and 12 weeks)
- EQ 5D 5L(6 weeks and 12 weeks)
- Self-Efficacy for Exercise Scale(6 weeks and 12 weeks)
- Exercise Regulations Questionnaire (BREQ-3)(6 weeks and 12 weeks)
- VAS Self-rated Capacity to Exercise, Confidence to Exercise and Motivation to Exercise(6 weeks and 12 weeks)
研究者
Jonathan Room
Senior Research Physiontherapist
Oxford University Hospitals NHS Trust