Acceptability, Fidelity, Safety and Preliminary Efficacy of a Sedentary Behaviour Intervention in Individuals With Spinal Cord Injury: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Intervention acceptability
研究概览
简要总结
Individuals with spinal cord injury have a greater risk of heart disease and stroke than non-disabled individuals. This might be partly because wheelchair users engage in high amounts of sedentary behaviour. A review found a lack of programmes aimed at reducing sedentary behaviour in individuals with paraplegia. This means we do not know how good these programmes are for reducing heart disease risk markers.
A programme to support reductions in sedentary behaviour has been co-designed with individuals with paraplegia, healthcare professionals, and people who support individuals with paraplegia in the community.
This study aims to evaluate the new programme to determine its acceptability, fidelity, safety and preliminary efficacy.
The Reducing sedEntary Activities to improve Cardiovascular Health in individuals with Spinal Cord Injury (REACH -SCI) intervention will last eight weeks and involve (1) a wearable activity tracker to give reminders to break up sedentary behaviour, (2) education around what sedentary behaviour is, how to reduce and break up sedentary behaviour, and the benefits of doing so, (3) a goal setting worksheet related to sedentary behaviour, (4) one-to-one motivational support sessions to help set goals, review progress and give motivation, (5) peer support using a group chat with other participants in a smartphone messaging app , and (6) activity tools (exercise bands and a handcycle) to support breaking up sedentary behaviour throughout the day.
Measurements of fatigue, pain, physical activity, sedentary behaviour, heart disease risk markers, wellbeing, anxiety, depression and quality of life will be taken at baseline before the programme starts and then again after the programme ends. Acceptability of the intervention and data collection procedures will be explored using semi-structured interviews and questionnaires.
详细描述
Background:
Individuals with a spinal cord injury are at a greater risk of heart disease and stroke than the general population. Many individuals with spinal cord injury sit for long periods due to being wheelchair users. Therefore, the increased risk of heart disease in this population may be partly linked to high levels of sedentary behaviour. However, the effects of sedentary behaviour interventions for individuals with paraplegia are not well understood. Also, interventions designed for non-disabled people are unlikely to be appropriate for individuals with paraplegia due to unique barriers linked to reliance on a manual wheelchair for mobility and other symptoms and limitations due to their injury.
A sedentary behaviour intervention tailored to the needs of individuals with paraplegia was co-designed with end users, healthcare professionals and key stakeholders . The primary aim of the study is to assess the acceptability, fidelity and safety of this co-designed intervention to reduce and break up sedentary behaviour in individuals with paraplegia. The main objectives are to:
- Explore participant acceptability of the intervention
- Explore fidelity of the intervention in the context of intervention components being delivered as planned, participant adherence and dosage
- Assess the safety of the intervention.
The secondary objectives are to:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Individuals with self-reported paraplegia i.e. complete or incomplete SCI at T1 or below. Traumatic, non-traumatic, complete and incomplete SCI will all be eligible.
- •At least 18 years of age.
- •Self-report using a manual wheelchair as their primary mode of mobility inside and outside of the home.
- •Able to travel to Brunel University of London to undertake study measurements.
- •Access to use of a smartphone or tablet with internet access.
- •Able to communicate in English at a level sufficient to understand the study, complete study measurements and engage fully with the intervention.
- •Able to provide informed consent.
- •Willing and able to provide fingertip blood samples and fast prior to measurement sessions.
- •Able to independently transfer to a treatment couch and lay supine to undertake anthropometric measurements.
排除标准
- •Self-reported heart condition, chest pain, dizziness, bone or joint problem, or any other condition that may be exacerbated by doing physical activity, as indicated via responses to the PAR-Q+.
- •Self-reported history of uncontrolled autonomic dysreflexia in the past 12 months.
- •Self-reported pregnancy.
- •Currently participating in another research project that involves an intervention.
结局指标
主要结局
Intervention acceptability
时间窗: At intervention end (8 weeks)
Following completion of the intervention, acceptability will be assessed via an adapted questionnaire with 5-point Likert scales and individual semi-structured interviews to explore constructs from the Theoretical Framework of Acceptability (TFA). The TFA assesses acceptability in the context of seven components (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy), as well as overall intervention acceptability.
Intervention fidelity
时间窗: From baseline to intervention end (8 weeks)
Intervention fidelity will be assessed using a checklist to record each component being delivered as planned. This will include participants being provided with the wearable activity tracker, educational booklet, goal setting worksheet, exercise bands and portable hand cycle. Fidelity to the educational resource will be evaluated verbally in one-to-one motivational support sessions. Attendance at each motivational support session and duration of these sessions will be recorded. This will be in addition to a checklist for all planned aspects of the sessions being covered by the researcher delivering the intervention sessions.
Intervention safety - Adverse events
时间窗: From baseline to intervention end (8 weeks)
Safety of the intervention will be evaluated through adverse events (AE) experienced during the study. These will be self-reported at each data collection point, during contact with a facilitator as part of the intervention, and ad-hoc throughout the study by contacting a member of the research team via phone or email.
Intervention safety - Pain
时间窗: Baseline and at intervention end (8 weeks)
Safety will also be evaluated by measuring pain using the McGill Pain Questionnaire (MPQ), which is validated in individuals with SCI. Pain will be rated across 20 domains of pain using rating scales. Overall pain will be scored from 0 to 78, with a higher score representing worse levels of pain.
Intervention safety - Fatigue
时间窗: Baseline and at intervention end (8 weeks)
Safety will also be evaluated by measuring fatigue using the Modified Fatigue Impact Scale (MFIS), which is validated in individuals with SCI. Fatigue will be rated on a 5-point scale according to 21 domains of fatigue. Overall fatigue will be scored between 0 and 84, with a higher score representing worse levels of fatigue.
次要结局
- Body fat mass(Baseline and at intervention end (8 weeks))
- Body fat percentage(Baseline and at intervention end (8 weeks))
- Fasting HDL cholesterol(Baseline and at intervention end (8 weeks))
- Total cholesterol to HDL cholesterol ratio(Baseline and at intervention end (8 weeks))
- Non-HDL cholesterol(Baseline and at intervention end (8 weeks))
- Subjective wellbeing(Baseline and at intervention end (8 weeks))
- Waist circumference(Baseline and at intervention end (8 weeks))
- Diastolic blood pressure(Baseline and at intervention end (8 weeks))
- Fasting glucose(Baseline and at intervention end (8 weeks))
- Physical activity(Baseline and in the final week of the intervention period)
- Body mass(Baseline and at intervention end (8 weeks))
- Body mass index(Baseline and at intervention end (8 weeks))
- Participant engagement(At intervention end (8 weeks))
- Acceptability of data collection procedures(At intervention end (8 weeks))
- Study feasibility(From recruitment to measurements taken at intervention end (8 weeks))
- Sedentary time(Baseline and in the final week of the intervention period)
- Systolic blood pressure(Baseline and at intervention end (8 weeks))
- Mean arterial pressure(Baseline and at intervention end (8 weeks))
- Fasting total cholesterol(Baseline and at intervention end (8 weeks))
- Anxiety(Baseline and at intervention end (8 weeks))
- Depression(Baseline and at intervention end (8 weeks))
- Health-related quality of life(Baseline and at intervention end (8 weeks))
研究者
Dr Daniel Bailey
Reader in Sedentary Behaviour and Health
Brunel University