Armergometry to Improve Mobility in Chronic Progressive Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 6 minute walking test
研究概览
简要总结
Chronic progressive multiple sclerosis patients will be randomised to home-based arm ergometry training for 12 weeks or a waitlist control group which will have access to the treatment after 12 weeks when primary endpoint assessment has been obtained. Assessments include clinical outcomes and questionnaires as well MRI imaging and transcranial magnetic stimulation paradigms. Primary endpoint will be the 6 minute walking test at week 12.
详细描述
Short protocol Design: Patients with progressive MS (PPMS, SPMS) and moderate disability (Expanded Disability Status Scale 4-6.5) will be randomized to home-based arm ergometry or a waitlist control group. Home-based training will be supervised by SD-card documentation, telephone, email and personal contact.
Inclusion criteria: clinically definite MS according to Poser (1983), no progression in the last 6 months before starting, no acute relapse, age 18- 65 years, EDSS 4-6.5, able to perform all arm- and handfunctions in daily life, able to execute a daily Training.
Exclusion criteria: medical contraindications for exercise therapy like cardiovascular or major orthopedic disease, metal parts in body, substantial cognitive deficit, cardiac pacemaker or other electric implants, pregnancy, epilepsy.
Recruitment sample: n=50 Participants for analysis: n= 40 Control group: Intervention available after 3 months Duration: 3 months, data acquisition until 12 months after intervention Hypothesis: Arm ergometry improves walking ability (measured by 6-Minute Walk Test, 6MWT). Secondary endpoints include cognition, fatigue, depression, life quality and blood markers as BDNF.
Primary endpoint: Walking ability is evaluated before and after the training program (12 weeks) using the 6MWT by measuring the total walking distance within six minutes.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •proven multiple sclerosis
- •stable disease
- •EDD 4,0-6,5
- •being able to perform arm ergometry
排除标准
- •relapse situation
- •cognitive deficit unable to understand study
- •cardivascular disease
- •contraindication for MRI
研究组 & 干预措施
arm ergometry
Home-based treatment after education in center, training following interval training plan on chip cards for 12 weeks at least 4-5 times/week
干预措施: arm ergometry (Behavioral)
waiting group
training after 12 weeks.
干预措施: arm ergometry (Behavioral)
结局指标
主要结局
6 minute walking test
时间窗: 6 min.
maximum distance in 6 minutes
次要结局
- verbal learning and memory(30 minutes)
- peak oxygene uptake(20 minutes)
- accelerometry(7 days)
- brain atrophy(3 months)
- Brain derived neurotrophic factor(3 months change)