Aix Marseille Univ, AP-HM, Hopitaux sud, Physical Rehabilitation Medicine Department, Marseille, France.
Aix-Marseille Univ, APHM, INT, P3M, Hopitaux Sud, Physical and Rehabilitation Medicine Department, Marseille, France.
BMJ Open. 2024 Jul 20;14(7):e084688. doi: 10.1136/bmjopen-2024-084688.
Physical activity (PA) protects the cardiovascular system and reduces the risk of stroke recurrence. However, most stroke survivors have significantly lower daily PA levels than those recommended. Adapted PA programmes provide a useful means of increasing the daily PA levels of this population. PA programmes designed to encourage people walking have been found to be more effective than no intervention. Some programmes have been applied in institutional settings while others are done on an independent basis. The aim of this study will be to compare the two methods in terms of their impact on the daily walking rates of subjects with spastic hemiparesis following a chronic stroke. Secondary outcomes will include effects on walking ability, endurance, balance, quality of life and motivation for exercise.
This French single-centre randomised (1:1), controlled, two-arm, parallel, single-blind study will include 40 adults with chronic stroke spastic hemiparesis who are able to walk for 6 min. The primary outcome will be the participants' daily activity measured via the number of steps performed per day using a Stepwatch device. We expect to establish that the institution-based programme will be more effective than a self-managed programme as a means of increasing the PA of chronic stroke subjects.
The protocol was approved by an independent National Ethics Committee (Comité de Protection des personnes Est IV). Participants will be asked to provide their signed informed consent prior to the study. The results will be disseminated via publications in the scientific literature, oral and poster presentations by partners at international scientific meetings and associations of patients.
NCT06061770.
身体活动(PA)可保护心血管系统并降低中风复发的风险。然而,大多数中风幸存者的日常 PA 水平明显低于推荐水平。适应性 PA 方案为提高该人群的日常 PA 水平提供了一种有用的方法。鼓励人们散步的 PA 方案已被证明比不干预更有效。一些方案已在机构环境中实施,而另一些则是独立进行的。本研究的目的将是比较这两种方法对慢性中风后痉挛性偏瘫患者日常步行率的影响。次要结局将包括对步行能力、耐力、平衡、生活质量和运动动机的影响。
这是一项法国单中心随机(1:1)、对照、双臂、平行、单盲研究,将纳入 40 名能够行走 6 分钟的慢性中风痉挛性偏瘫成年人。主要结局将是使用 Stepwatch 设备测量参与者每天的活动量,即每天完成的步数。我们预计,机构基础方案将比自我管理方案更有效地增加慢性中风患者的 PA。
该方案已获得独立的国家伦理委员会(Comité de Protection des personnes Est IV)的批准。在研究开始前,将要求参与者签署知情同意书。结果将通过在科学文献中发表、合作伙伴在国际科学会议和患者协会上进行口头和海报展示来传播。
NCT06061770。