Effects of Exercise and Rivastigmine on Quality of Life of Alzheimer's Disease Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Patients' Quality of life
研究概览
简要总结
The purpose of this study is to determine whether a exercise program when combined with rivastigmine (Exelon patch) drug treatment compared with rivastigmine drug treatment alone would improve quality of life, ability to perform activities of daily living (ADL) and cognition in patients with Alzheimer's disease.
Hypothesis:
Ho: Rivastigmine drug treatment combined with exercise is not superior to rivastigmine drug treatment to improve quality of life of Alzheimer's disease patients.
H1: Rivastigmine drug treatment combined with exercise is superior to rivastigmine drug treatment to improve quality of life of Alzheimer's disease patients, with an expectative of 15% of improvement in the quality of life scale measurement
详细描述
After screening and informed consent, that will be collected demographical data from patient. Another researcher will evaluate the cognition, through MMSE; the activities of daily living, through Activities of Daily Living Questionnaire of Alzheimer disease; patient and caregiver's quality of life through Quality of life scale in Alzheimer's disease (QOL-AD); functional mobility, through Time Up and Go test.
Afterwards, the pharmacist will give the medicine, orientations about its administration and clarify possible doubts. Therapy will begin with the small patch of 5 mg/24 h and, if well tolerated, the dose will be increased to the 10 mg/24 h patch.
The patients will be randomly assigned, through a computer program list, to exercise or control group. The patient and caregiver exercise group will receive information about the two-day/week exercise program at physiotherapy ambulatory. Monthly, all patients and caregiver will be clinically reevaluated during six months.
The forty minutes exercise program will include aerobic, strength, flexibility and balance training, organize in the follow sequence:
- Ten minutes of global stretching (shoulder girdle, upper limbs, lower limbs and trunk) along the beginning and final of the session. Each stretch posture will last 30 seconds.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous diagnosis of probable Alzheimer's disease
- •At least 55 years of age
- •Same caregiver (familiar or paid one) for at least 3 months before, who is able to follow the patient in a two-day/week exercise program
- •Do not be taking other prescribed medication for Alzheimer disease
- •Treated stable hypertension
排除标准
- •Mini-Mental State Examination (MMSE) score of less than 12
- •Can't follow simple commands;
- •Can't answer two or more items of Quality of life questionnaire
- •Practiced regular exercise or physiotherapy/ occupational therapy in the last two months.
- •Diagnosed psychiatric condition (including depression).
- •Use of neuroleptic drugs
- •Orthopedic, neurologic, or behavioral limitations that may preclude exercise training
- •Visual or hearing impairment that may preclude exercise training or comprehension
研究组 & 干预措施
Rivastigmine and exercise program
Experimental group: Rivastigmine and exercise program: All patients will monthly receive Rivastigmine (Exelon patch). The exercise training program consists of two 40-minute sessions per week for six months and includes aerobic, strength, flexibility and balance training
干预措施: Rivastigmine (Drug)
Rivastigmine and exercise program
Experimental group: Rivastigmine and exercise program: All patients will monthly receive Rivastigmine (Exelon patch). The exercise training program consists of two 40-minute sessions per week for six months and includes aerobic, strength, flexibility and balance training
干预措施: Exercise training program (Other)
Rivastigmine
Control group : Rivastigmine All patients will monthly receive Rivastigmine (Exelon patch)
干预措施: Rivastigmine (Drug)
结局指标
主要结局
Patients' Quality of life
时间窗: Monthly for six months
Patients' Quality of life of assessed by Quality of life scale in Alzheimer's disease (QOL-AD)- Portuguese version
次要结局
- Cognition(Monthly for six months)
- Caregivers' Quality of life(Monthly for six months)
- Activities of daily living(Monthly for six months)
- Functional mobility(Monthly for six months)
研究者
Ailton de Souza Melo
Ailton de Souza Melo,PhD
Federal University of Bahia