Effect of Nordic Walking Training Compared With Conventional Endurance Training in Walking Capacity in People With Multiple Sclerosis: a Simple Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- 6 Minute Walk Test (6MWT)
研究概览
简要总结
Walking capacity is one of the most valuable body functions among persons with multiple sclerosis (MS) and it is one of the most frequently affected, even in early stages of the disease. Inactivity and deconditioning can accelerate gait impairment and promote other pathologies related with sedentary lifestyle.
Nordic walking (NW) is a fun and effective fitness and rehabilitation activity. The benefits of NW have been extensively described in healthy and elderly population (Tschentscher, 2013; Kappor, 2013) and it is proving to be highly recommended to different neurological conditions, specially to Parkinson Disease (Reuter 2006; van Eijkeren 2008; Fritz 2011; Ebersbach 2014).
There is no evidence on NW and MS, although it's supposed to be an ideal physical activity for many reasons: it tones the upper and lower body at the same time, uses 90% of the skeletal muscles, burns up to 46% more calories than ordinary walking, reduces the pressure on knees and joints, poles propel the walker along easier and faster and it is one of the most effective cross training techniques for people who require improve cardiovascular and endurance conditioning.
详细描述
A simple blinded randomized controlled trial as designed to assess if an endurance training (20 sessions of 45 minutes x 2 times/week x 10 weeks) using NW improves: walking capacity, balance, fatigue, mood and health-related quality of life of people with MS.
66 people with MS will be randomly allocated in NW group or conventional endurance training group (treadmill and cycloergometer). Assessments will take place before starting the training, after the training and 3 months after.
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
- •People over 18 diagnosed of MS following the Mc Donald criteria, clinically stable who:
- •show mild to moderate balance disorder (BBS>45). Mild risk of falls.
- •refer fatigue during walking and restriction on their usual walking distance during the last 6 months.
- •Accept to participate in the study and signed the informed consent.
排除标准
- •Other neurological disorders.
- •Moderate to severe spasticity (Ashworth>2)
- •Non stable heart diseases, diabetes mellitus, arthritis in lower limbs, acute pain in lower limbs, peripheral neuropathies, severe orthopedics problems, psychiatric problems, pregnancy.
- •Incapacity to maintain a minimum walking rhythm at least during 15 minutes.
- •Cognitive disability or body schema disorder that limits to fill in the assessment questionaires or understanding and applying the technique.
- •To be training in other physical activities that can modify the level of fatigue or walking ability.
结局指标
主要结局
6 Minute Walk Test (6MWT)
时间窗: Assessment will take place at baseline and after 10 weeks
Maximal distance (in meters) walked during 6 minutes
Change from baseline 6 Minute Walk Test (6MWT) to 6 months
时间窗: Assessment will take place up to 6 months, through the study completion
Maximal distance (in meters) walked during 6 minutes
次要结局
- Change from baseline Timed 25 Foot Walk Test to 6 months(Assessment will take place up to 6 months, through the study completion)
- Change from baseline Multiple Sclerosis Walking Scale 12 to 6 months(Assessment will take place up to 6 months, through the study completion)
- Berg Balance Scale(Assessment will take place at baseline and after 10 weeks)
- Change from baseline Modified Fatigue Impact Scale to 6 months(Assessment will take place up to 6 months, through the study completion)
- Change from baseline Multiple Sclerosis Quality of Life 54 to 6 months(Assessment will take place up to 6 months, through the study completion)
- Multiple Sclerosis Walking Scale 12(Assessment will take place at baseline and after 10 weeks)
- Timed 25 Foot Walk Test(Assessment will take place at baseline and after 10 weeks)
- Timed Up and Go Test(Assessment will take place at baseline and after 10 weeks)
- Change from baseline Timed Up and Go Test to 6 months(Assessment will take place up to 6 months, through the study completion)
- Change from baseline Berg Balance Scale to 6 months(Assessment will take place up to 6 months, through the study completion)
- Activities Specific Balance Confidence Scale(Assessment will take place at baseline and after 10 weeks)
- Multiple Sclerosis Quality of Life 54(Assessment will take place at baseline and after 10 weeks)
- Change from baseline Activities Specific Balance Confidence Scale to 6 months(Assessment will take place up to 6 months, through the study completion)
- Modified Fatigue Impact Scale(Assessment will take place at baseline and after 10 weeks)