NCT03244813已完成不适用
Evaluation of the Impact of a Personalized Program of Adapted Physical Activates in Patients With Parkinson Disease
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2018年1月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Evaluate the impact of an adapted physical activity (APA) program versus standard care on the activity of patients with Parkinson Disease
研究概览
简要总结
Our study aims to compare the effects of a standard care plan to one using adapted physical activity in patients with Parkinson Disease. Using actigraphy as an evaluation measure will allow the collection of quantitative and objective data related to activity in contrast to questionnaires which are more subjective and dependent on self-representation. In addition, the evaluation of the caregiver's actigraphy and hardship (Zarit scale) will provide interesting data from this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The medical team assessing patient functional capacities and caregiver burden at 3 and 6 months will not know which treatment the patient received
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient and their carer have given their free and informed consent and signed the consent form
- •The patient must be insured of the beneficiary of an insurance policy
- •The patient is available for the 6 month follow-up
- •The patient is between 40 and 80 years old
- •The patient has experienced symptoms of Parkinson Disease for at least 5 years and is in a stable state (no medical event or change of treatment in at least 1 month)
- •The functional impact and duration of fluctuations is ≥3 (MDS UPDRS)
- •The patient can walk autonomously, including using a technical aid
- •The patient does not have any regular physical activity excluding physiotherapy sessions
- •The patient has daily help from a caregiver
排除标准
- •The subject and/or their caregiver is participating in another study
- •The subject and/or their caregiver is in a period of exclusion determined by a previous study
- •The patients is under judicial protection or state guardianship
- •It proves impossible to give the patient and/or the caregiver clear information
- •The patients and/or the caregiver reuses to sign the consent form
- •The patient is pregnant or breast feeding
- •The patient has anxiety or depression (Score HAD≥ 11/14), cardiac or respiratory failure (stress test), vesico-sphincter problems preventing normal practice of a physical activity, a contraindication to adapted physical activities
- •The patient cannot walk
- •Muscular tremor preventing the actigraphy measurement. Outside normal range values for UPDRS measures of: 3.15) postural tremor of the hands; 3.16) action tremor of the hands; 3.17) amplitude of rest tremor
结局指标
主要结局
Evaluate the impact of an adapted physical activity (APA) program versus standard care on the activity of patients with Parkinson Disease
时间窗: 3 months
previous weeks' activity measured by actigraphy
次要结局
- Activity of the care giver(6 months)
- Quality of life of patients undertaking APA verses standard care(6 months)
- Endurance and speed of walking of patients undertaking APA verses standard care(6 months)
- Patient dependence(6 months)
- Evaluation of the care burden of care giver(6 months)
- Grip strength(6 months)
- Level of dementia at Day(6 months)
- Activity of patients in both groups(6 months)
- Risk of fall of patients undertaking APA verses standard care(6 months)
研究者
研究点 (2)
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