Physical Activity Program for Patients With Dementia and Their Relative Caregivers. Randomized Clinical Trial in Primary Health Care. APISDEMyF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Physical activity (podometer and 7-Day PAR) in patients and caregivers
研究概览
简要总结
Objective: To assess the effectiveness of an intervention in Primary Health Care to increase the physical activity (PA) and improve cognitive state and cardiovascular risk in patients with dementia and their relative caregivers.
The results can be used to improve the technical characteristics of the devices that record the physical activity of patients with dementia make marketing easier
详细描述
Methodology: Design: Clinical, multicentric and randomized trial. A simple random sampling to select 134 patients diagnosed with dementia will be carried out. After contacting their relatives, his/her participation in the trial will be requested. A basal assessment will be made and the participants will be assigned to control or intervention group (1:1). Variables: The main measure will be the assessment of PA (pedometer and 7-Day PAR) in patients and caregivers. In patients: ADAS-cog, functional degree and cardiovascular risk. In caregivers: cardiovascular risk, general health and quality of life.
INTERVENTION: For 3 months, participants will receive instructions to do PA with an adapted PA program. This program will be designed and applied by Primary Health Care professionals in patients with dementia and caregivers. The control group will receive regular care.
ANALYSIS: An intention-to-treat analysis will be carried out by comparing the observed differences between basal, 6 and 12 months measures. Change in the mean of daily steps assessed with the pedometer and 7-day PAR will If the main hypothesis is confirmed , it could be useful to improve the cardiovascular risk of all of them , as well as the cognitive state of patients with dementia..
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with dementia residing in a home in the area of the health center.
- •identification of family members, or friends (not professional caregiver), who provide most of the care to the PCD.
- •completion of informed consent on the part of the caregiver (and PCD) where appropriate.
- •the PCD does not take drugs that may negatively affect cognitive function during the period of intervention.
排除标准
- •mental disorders due to diseases, medical or related substances (DSM-IV-TR).
- •stages of dementia (6 or 7 GDS),
- •comorbidity that prevents performing the exercise program intervention: unstable heart disease, bedridden, need walkers or wheelchair, diseases significant stroke, bone and muscle disorders, major psychiatric, neurological or metabolic alterations.
- •severe clinical events within the 6 months prior.
- •on waiting list of surgical interventions or treatments that require a hospital stay, or forecast stays out of the capital more than 4 weeks during the intervention.
- •the caregiver dissent to participate in the trial.
- •participants who submit any psychological or general medical condition which in the opinion of the investigator may impede the fulfilment of the questionnaires in the Protocol
- •participants who are participating at the time of the start of the study in a clinical trial or study with medications.
结局指标
主要结局
Physical activity (podometer and 7-Day PAR) in patients and caregivers
时间窗: 12 months
The main measure will be the assessment of PA (podometer and 7-Day PAR) in patients and caregivers.
次要结局
- ADAS-cog, functional degree and cardiovascular risk(12 months)