"Outwalk MS" - Benefits of Outdoor Walking Exercise Therapy on Walking Capacity and Well-being in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 6-minutes walk test (6MWT)
研究概览
简要总结
Deterioration of walking capacity is a common symptom in persons with multiple sclerosis (pwMS), furthermore having a negative influence on well-being. Studies have nevertheless shown that walking exercise therapy can improve walking capacity in pwMS. This may be particularly potent if occurring outdoors due to the varying stimuli it can provide (different surfaces and terrain etc.), and if the intensity and duration is adequate. Furthermore, outdoor walking is (1) suitable as a group intervention facilitating interaction between pwMS and (2) advantageous due to the health benefits offered through the interaction with nature itself. Both these aspects are also relevant for well-being.
Few studies have nevertheless examined the effects of outdoor walking exercise therapy in pwMS. The purpose of the present study is therefore to examine the effects of 7 weeks of moderate-to-high intensity outdoor walking exercise therapy on walking capacity (primary outcome: 6-minute walk test) and well-being in pwMS.
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
- Single (Outcomes Assessor)
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
- •≥ 18 years
- •self-reported clinical MS diagnosis
- •PDDS ≤ 4 (corresponding to preserved walking capacity without assistive devices of at least 10 m)
- •able to independently attend the testing
排除标准
- •self-reported comorbidities excluding participation in the intervention
- •recent (6 months retrospective) fractures, amputation or other critical physical impairments that eliminates participation in the described training study
- •participation in structured exercise therapy (including walking) for the past 3 months (≥ 2 session per week of moderate-to-high intensity)
结局指标
主要结局
6-minutes walk test (6MWT)
时间窗: Change from baseline (Pre) to after 7 weeks intervention (Post)
Maximal distance covered in 6 minutes using a 30 meter walkway. Assesses walking endurance.
次要结局
- 6-minutes walk test (6MWT)(Change from baseline (Pre) to 24 weeks follow-up (Follow-up))
- Timed 25-foot walk test (T25FWT)(Change from baseline (Pre) to 24 weeks follow-up (Follow-up))
- Six spot step test (SSST)(Change from baseline (Pre) to 24 weeks follow-up (Follow-up))
- 12-item multiple sclerosis walking scale (MSWS-12)(Change from baseline (Pre) to 24 weeks follow-up (Follow-up))
- WHO five well-being index (WHO5)(Change from baseline (Pre) to 24 weeks follow-up (Follow-up))
- EuroQoL 5 dimensions 3 levels (EQ5D)(Change from baseline (Pre) to 24 weeks follow-up (Follow-up))
- Modified fatigue impact scale (MFIS)(Change from baseline (Pre) to 24 weeks follow-up (Follow-up))
- Falls-efficacy scale (FES-I)(Change from baseline (Pre) to 24 weeks follow-up (Follow-up))
- Patient-determined disease steps (PDDS)(Change from baseline (Pre) to 24 weeks follow-up (Follow-up))
- Baecke physical activity questionnaire(Change from baseline (Pre) to 24 weeks follow-up (Follow-up))