A Remote Physical Activity Program Via the PACE Tool to Counter the Physical Impairments, Accentuated by the Pandemic, in the Population Suffering from Type 1 Myotonic Dystrophy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Change in Functional capacity from baseline to week 12
研究概览
简要总结
The COVID-19 pandemic exacerbates health problems by reducing access to adapted and advanced physical rehabilitation for several people who need rehabilitation services, including the population with myotonic dystrophy type 1 (DM1). The PACE tool, an innovative web tool integrating pragmatic physical activity programs, seems to be an interesting and innovative intervention to counter physical deficiencies of people with DM1, which are unfortunately accentuated by the pandemic, while reducing the risk of COVID-19 exposure. Objectives: 1) Evaluate the feasibility, usability and acceptability of the PACE tool in the DM1 population; 2) Evaluate the effects of the intervention on their physical and cognitive health; and 3) Estimate the cost-effectiveness ratio of this intervention. Method: Sixty people (experimental group = 40 and control group = 20) will participate in this randomized intervention study. Participants in the experimental group will be assigned to one of the 35 physical activity programs adapted to their condition of the PACE tool. The program must be performed on a daily basis for a period of 12 weeks. Physical and cognitive health will be assessed before and after the remote intervention via ZOOM, for all participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DM1 diagnosis must be confirmed by genetic analysis (juvenile, adults or late-onset phenotypes);
- •Aged between 18 and 60 years old;
- •Be able to do exercise;
- •Subjects must be able to give their consent freely and voluntarily.
排除标准
- •Patients who already train (>3 times per week or >150min/week);
- •Don't speak french or english;
- •Are not able to do exercise (even in sitting position);
结局指标
主要结局
Change in Functional capacity from baseline to week 12
时间窗: Week 12
Short physical performance battery Functional reach test
Change in the Level of physical activity from baseline to week 12
时间窗: Week 12
Rapid Assessment of physical Activity \& International Physical Activity Questionnaires
Feasability/acceptability of the program and Satisfaction
时间窗: Week 12
Number of sessions completed/planned Likert System Usability Scale.
次要结局
- Changes in the score of the Fatigue and Daytime Sleepiness Scale from baseline to week 12(Week 12)
- Changes in the Marin apathy scale from baseline to week 12(Week 12)