跳至主要内容
临床试验/NCT03114293
NCT03114293Unknown不适用

Evidence Based Patient Information and Smartphone Accelerometry to Enhance Physical Activity in MS

Universitätsklinikum Hamburg-Eppendorf0 个研究点目标入组 40 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
Rate of responders

研究概览

简要总结

Due to their ubiquitary distribution, smartphones might serve as an easy way/ possibility to use feedback mechanism in an app-based intervention program to increase physical activity in Multiple Sclerosis (MS) patients. Internet based cognitive-behavioral interventions have been explored as effective in the last years. In addition, smartphone-based mobility assessment and intervention might be a promising approach in other MS types and for real-life mobility assessment in observational and interventional trials. The aim is to investigate the impact of a smartphone based information and feedback program on physical activity in a 3 months, randomised waiting-group controlled trial of 40 progressive MS patients.

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
Double (Investigator, Outcomes Assessor)

盲法说明

Rater blinded.

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

入选标准

  • progressive MS

排除标准

  • other major health disorder
  • EDSS above 6

结局指标

主要结局

Rate of responders

时间窗: 3 Months

Rate of responders as defined by a 20% increase of steps or 20% increase in physical activity as measured with the actigraph

次要结局

  • Physical activity: distance per day(3 Months)
  • Physical activity: total activity(3 Months)
  • Questionnaires on physical activity(3 Months)
  • Physical activity: number of steps per day(3 Months)
  • Questionnaires on quality of life (QoL, HAQUAMS)(3 Months)
  • Questionnaires on activities of daily living (ADL)(3 Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jan-Patrick Stellmann

MD

Universitätsklinikum Hamburg-Eppendorf

相似试验