Controlled Trial Testing the Effectiveness of Motivational Support on Physical Activity and Fatigue of Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Change in physical activity
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of an 8-week intervention based on implementation intention (motivation) in patients with multiple sclerosis on objectively measured physical activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Adult aged between 18 and 65 years
- •Multiple sclerosis
- •Recruited from CHU Poissy saint germain or Hôpital Raymond-Poincaré
- •Informed consent provided during inclusion interview
排除标准
- •Already participating in a clinical trial
- •Cognitive dysfunctions in understanding simple guidelines
- •Treatment reducing fatigue since less than 3 months
- •Psychiatric disorders
- •Unability to exercise
- •Previous cardiovascular diseases
- •Regular physical activity practice
研究组 & 干预措施
Motivation
Using implementation intention techniques such as action planning. Every week, participants state when, where, and what kind of prescribed exercises they will do.
干预措施: Motivation (Behavioral)
Mindfulness
10 minutes of audio recordings daily. Recordings contain: awareness of the breath, acceptation of thoughts and emotions, awareness of postures, awareness during stretching, awareness of a single movement (moving legs up while standing).
干预措施: Motivation (Behavioral)
Treatment as usual
Physical activity prescribe 120 minutes per week.
结局指标
主要结局
Change in physical activity
时间窗: From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
Accelerometer on a daily basis for 7 days
次要结局
- Change in self-reported anxiety and depression (HADS)(From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.)
- Change in self-reported mindfulness skills (FFMQ)(From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.)
- Change in self-reported motivational regulation toward exercise (BREQ)(From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.)
- Change in self-reported beliefs toward physical activity (TPB).(From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.)
研究者
Ruffault Alexis
PhD
University of Paris 5 - Rene Descartes