Changing physical activity behaviour for people with multiple sclerosis: protocol of a randomised controlled feasibility trial (iStep-MS).

Changing physical activity behaviour for people with multiple sclerosis: protocol of a randomised controlled feasibility trial (iStep-MS).
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DOI:
10.1136/bmjopen-2017-018875
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发表时间:
2017-11-15
期刊:
影响因子:
2.9
通讯作者:
Norris M
Norris M
中科院分区:
医学3区
文献类型:
--
作者:
Ryan JM;Fortune J;Stennett A;Kilbride C;Anokye N;Victor C;Hendrie W;Abdul M;DeSouza L;Lavelle G;Brewin D;David L;Norris M

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尽管身体活动可以减轻多发性硬化症 (MS) 患者的疾病负担、疲劳和残疾,并提高生活质量,但许多多发性硬化症患者缺乏身体活动,并且花费大量时间久坐。行为改变干预措施可以帮助多发性硬化症患者增加体力活动并减少久坐行为。然而,很少有研究使用客观的体力活动指标来调查其有效性,特别是从长期来看。此外,由于提供了大量支持,短期内被证明有效的干预措施在临床实践中可能并不可行。 iStep-MS 试验旨在确定行为改变干预措施的安全性、可行性和可接受性,以增加多发性硬化症患者的体力活动并减少久坐行为。 60 名多发性硬化症患者将被随机(1:1 比例)接受为期 12 周的干预或仅接受常规护理。该干预措施包括与物理治疗师进行四次体育活动咨询,并配有手册和计步器。基线、12 周和 9 个月时评估的结果包括体力活动(ActiGraph wGT3X-BT 加速计)、久坐行为 (activPAL3µ)、自我报告的活动和静坐时间、步行能力、疲劳、自我效能、参与度、生活质量和健康服务使用。干预措施的安全性将通过评估随访期间疼痛和疲劳的变化以及不良事件的发生率来确定。并行过程评估将通过评估对计划的忠诚度以及探索参与者和治疗师的干预经历的半结构化访谈来评估干预的可行性和可接受性。进行经济评估的可行性将通过收集生活质量和资源利用的数据来确定。研究伦理委员会已获得伦敦布鲁内尔大学的批准。试验结果将提交在期刊上发表,并分发给多发性硬化症患者和物理治疗师。 ISRCTN15343862(doi 10.1186/ISRCTN15343862)。协议版本:1.0;预结果。
Although physical activity may reduce disease burden, fatigue and disability, and improve quality of life among people with multiple sclerosis (MS), many people with MS are physically inactive and spend significant time in sedentary behaviour. Behaviour change interventions may assist people with MS to increase physical activity and reduce sedentary behaviour. However, few studies have investigated their effectiveness using objective measures of physical activity, particularly in the long term. Further, interventions that have proven effective in the short term may not be feasible in clinical practice because of the large amount of support provided. The iStep-MS trial aims to determine the safety, feasibility and acceptability of a behaviour change intervention to increase physical activity and reduce sedentary behaviour among people with MS. Sixty people with MS will be randomised (1:1 ratio) to receive a 12-week intervention or usual care only. The intervention consists of four physical activity consultations with a physiotherapist supported by a handbook and pedometer. Outcomes assessed at baseline, 12 weeks and 9 months are physical activity (ActiGraph wGT3X-BT accelerometer), sedentary behaviour (activPAL3µ), self-reported activity and sitting time, walking capability, fatigue, self-efficacy, participation, quality of life and health service use. The safety of the intervention will be determined by assessing change in pain and fatigue and the incidence of adverse events during the follow-up period. A parallel process evaluation will assess the feasibility and acceptability of the intervention through assessment of fidelity to the programme and semistructured interviews exploring participants’ and therapists’ experiences of the intervention. The feasibility of conducting an economic evaluation will be determined by collecting data on quality of life and resource use. Research ethics committee approval has been granted from Brunel University London. Results of the trial will be submitted for publication in journals and distributed to people with MS and physiotherapists. ISRCTN15343862 (doi 10.1186/ISRCTN15343862). Protocol version: 1.0; Pre-results.
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发表时间: 2015-10
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