Evaluation of a Personalized Physical Activity Coaching Program in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from baseline of the Unified Parkinson Disease Rating Scale part III score
研究概览
简要总结
There is growing interest for physical activity in Parkinson's disease in order to improve mobility and function of these patients. It seems from previous studies that difficulty, intensity and specificity of physical exercises are important parameters conditioning the effect of physical activity on cerebral plasticity and clinical improvement.
Thus, the aim of this study is to evaluate the benefits of a Personalized Physical Activity coaching program, including scheduled and frequent follow up associated with progressive readaptation of exercise intensity depending on individual performances (during 3 months), versus free practice of physical activity in Parkinson's disease.
详细描述
Type of study: a randomized, single-blind, parallel-group, controlled clinical trial.
Number of centers: 1 (Clermont-Ferrand)
Patients
Patients eligible for inclusion will be randomized to one of the two groups:
- APA + : patients will beneficiate of Personalized Physical Activity coaching program during 3 months (1 hour, twice by week, during 3 months)
- APA- : patients will do free practice of physical activity during 3 months.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical criteria for Parkinson's disease
- •Men or women aged from 18 to 80 years old.
- •Social security coverage.
- •Ability to provide informed consent.
排除标准
- •neurological disease other than Parkinson's disease
- •severe depression (Beck Depression Inventory>37) or psychiatric comorbidities (UPDRS I )
- •significant cognitive impairment (MoCA<24)
- •orthopedic impairment with functional restriction
- •contraindication to physical exercise
结局指标
主要结局
Change from baseline of the Unified Parkinson Disease Rating Scale part III score
时间窗: at +3months
次要结局
- Change from baseline of percentage of sedentarity, mild, moderate and intense activity using the eMOUVE application(at + 6 months)
- Change from baseline of VO2pic(at + 6 months)
- dropout rates(at +6 months)
- Change from baseline of muscular strength measured with isometric test(at +6months)
- Change from baseline of the 6 min Walking Test score(at + 6 months)
- Change from baseline of the Lawton and Brody Activities of Daily Living scale score(at +3months)
- Change from baseline of the percentage of sedentarity, mild, moderate and intense activity using the eMOUVE application(at +3months)
- Change from baseline of balancing abilities measured by stabilometry(at + 6 months)
- Change from baseline of fat and lean body mass measured by DEXA(at +3 months.)
- Change from baseline of Parkinson's Disease Questionnaire 39-item version score(at +3months)
- Change from baseline fat and lean body mass measured by DEXA(at +6 months.)