A Pilot Study for Continuous Monitoring of Physical Activity Using Activity Armbands for 6 Months: Assessment of Feasibility and Comparison to Self-reported Questionnaires
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Feasibility of activity monitoring armband to assess physical activity in ME/CFS patients
研究概览
简要总结
The investigators will assess the feasibility of activity monitoring armbands for continuous measurement of physical activity level in ME/CFS patients, during 6 months follow-up. The main purpose is to assess if continuous measurement of activity level may be incorporated in outcome measures in future clinical interventional trials.
详细描述
The purpose is to assess feasibility of activity monitoring armbands for continuous measurement of physical activity level in patents with Myalgic Encephalopathy/ Chronic Fatigue Syndrome (ME/CFS), during 6 months follow-up.
The investigators will assess which physical activity parameters that best seem to reflect the participant's own perception of activity level, such as mean number of steps per 24 hours.
The investigators will assess the agreement between continuous activity measurements by activity armbands, and self-reported questionnaires for health-related quality of life (SF-36 ver.2) and for ME/CFS symptoms (DSQ-SF).
The investigators will assess the agreement between activity monitoring by armbands, and previously validated activity monitoring bracelets for 5-7 consecutive days, at baseline, at 3 months and at 6 months follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients wit ME/CFS according to Canadian Consensus Criteria (2003)
- •ME/CFS disease duration at least 2 years
- •Mild, Mild/moderate, Moderate, Moderate/Severe and Severe ME/CFS may be included
- •Signed informed consent
排除标准
- •Patients with fatigue, who do not meet the diagnostic "Canadian" criteria (2003) for ME/CFS
- •ME/CFS disease duration < 24 months
- •Patients where the diagnostic workup uncovers other pathology as possible cause of symptoms
- •Serious endogenous depression
- •Lack of ability to complete the study including follow-up
结局指标
主要结局
Feasibility of activity monitoring armband to assess physical activity in ME/CFS patients
时间窗: 6 months
Feasibility of activity monitoring armbands to assess level of physical activity in ME/CFS patients, with comparison of activity data to self-reported questionnaires for quality of life (SF-36 ver.2) and for ME/CFS symptoms (DSQ-SF)
次要结局
未报告次要终点