Internet-based Physical Activity Promotion and Exercise Prescription for People With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 18
- 主要终点
- Changes in objectively measures physical activity
研究概览
简要总结
The aim of the study is to evaluate the effects of a 12-week internet-based exercise and physical activity promotion intervention on physical activity. Furthermore, effects on symptoms of Multiple Sclerosis, Physical Activity-related Health Competence (PAHCO), self-concordance and basic needs satisfaction as well as usability and acceptability of the intervention will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
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
- •diagnosed Multiple Sclerosis (McDonald criteria)
- •Expanded Disability Status Scale between 0 - 6.5
- •neurologically stable (no exacerbation within 30 days prior to enrollment)
- •internet access (WiFi)
- •basic knowledge on handling personal computer and the internet
- •owning a smartphone with the operating system Android or IOS and with access to Google Play Store or Apple App score
- •basic computer and internet skills (e. g. using web browser and webcams)
- •ability to operate a smartphone (especially to install mobile applications)
- •ability to read, write and comprehend as well as communicate electronically
排除标准
- •regularly physically active (more than 30 minutes twice a week with at least moderate intensity; includes aerobic training, resistance training and other sports e.g. Tennis; excludes physiotherapy, physical activity during work or household, grocery shopping, gardening, walking the dog etc.)
- •clinically relevant cardiovascular diseases
- •cortisone therapy in the last 30 days
- •cognitive impairment that hampers study implementation
- •severe impairment of hand function (ataxia or paresis impeding the use of a smartphone app or smartwatch)
- •severe internal, orthopaedic and metabolic diseases that restrict mobility
结局指标
主要结局
Changes in objectively measures physical activity
时间窗: Baseline, after 3 months, after 6 months
The physical activity level of participants is measured over a 7 day period with the accelerometer Actigraph GT3X+. The Actigraph GT3X+ measures acceleration on three axes. Steps per day, physical activity per day (activity counts) and time in moderate and vigorous physical activity per day will be calculated.
次要结局
- Changes in subjectively measured physical activity: BSA-Questionnaire(Baseline, after 3 months, after 6 months)
- Timed 25-Foot Walk Test (T25FW)(Baseline, after 3 months, after 6 months)
- Würzburger Fatigue Inventory for MS (WEIMuS)(Baseline, after 3 months, after 6 months)
- Multiple Sclerosis Walking Scale-12(Baseline, after 3 months, after 6 months)
- Physical activity-related health competence questionnaire(Baseline, after 3 months, after 6 months)
- Allgemeine Depressionsskala (ADS-L)(Baseline, after 3 months, after 6 months)
- Multiple Sclerosis Impact Scale (MSIS-29)(Baseline, after 3 months, after 6 months)
- Two-minute Walk Test (2MWT)(Baseline, after 3 months, after 6 months)
- German psychological need satisfaction in exercise scale(Baseline, after 3 months, after 6 months)
- Selbstkonkordanz-Skala (SSK-Scale)(Baseline, after 3 months, after 6 months)
- Usability and usefulness of the mobile application (meCue 2.0 questionnaire)(after 3 months, after 6 months)
- Usability and usefulness of the intervention(after 3 months, after 6 months)
研究者
Prof. Dr. Klaus Pfeifer
Head of the Department of Sport Science and Sport
University of Erlangen-Nürnberg