Effect of an Internet-based At-home Physical Training Protocol on Quality of Life, Fatigue, Functional Performance, Aerobic Capacity and Muscle Strength in Multiple Sclerosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 主要终点
- Change in Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HAQUAMS)
研究概览
简要总结
In this randomised controlled trial, the feasibility and effectiveness of an internet-based exercise intervention including progressive strength and endurance training (e-training) for PwMS was investigated. Primary outcome was health-related quality of life, secondary outcomes were muscle strength, aerobic capacity and lung function, physical activity and fatigue.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed Multiple Sclerosis (McDonald criteria),
- •an EDSS score of less than or equal to 4.0,
- •not less than 4 weeks of clinical stability prior to inclusion in the study,
- •access to the internet.
- •the taking of immunotherapeutic agents was not relevant and not monitored
排除标准
- •primary progressive multiple sclerosis
- •clinically relevant internal disease, especially cardiovascular or pulmonary disease, metabolic and orthopedic diseases
结局指标
主要结局
Change in Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HAQUAMS)
时间窗: Assessments took place at baseline and at 3 months
38 items generate the subscales of fatigue/thinking, mobility of the lower/upper extremities, communication and mood. The HAQUAMS total score is calculated from a mean of the subscales, providing a total score between 1 and 5. Higher scores in HAQUAMS indicate lower levels in HRQoL. The primary outcome will be the change over time from baseline to month 3.
次要结局
- Aerobic capacity(Assessments took place at baseline and after 3 and 6 months)
- Würzburg Fatigue Scale (WEIMuS)(Assessments took place at baseline, at 3 and 6 months)
- Muscle strength lower extremities(Assessments took place at baseline and after 3 and 6 months)
- Forced vital capacity(Assessments took place at baseline and after 3 and 6 months)
- Physical activity(Assessments took place at baseline and after 3 and 6 months)
- Peak expiratory flow(Assessments took place at baseline and after 3 and 6 months)
研究者
Prof. Dr. Klaus Pfeifer
Prof. Dr.
Friedrich-Alexander-Universität Erlangen-Nürnberg