Benefits of Exercise in Alzheimer's Disease
2019年9月24日 更新者：Carmela Tartaglia、University Health Network, Toronto
Assessing the Benefits of an Outpatient Aerobic Activity Program in Patients With Alzheimer's Disease
Exercise has been shown to be beneficial for the brain.
The investigators would like to test this specifically for those diagnosed with Alzheimer's disease.
This study will involve 30 randomized patients to take part in the out-patient exercise program and 30 patients to continue with their regular activities over a 6-month period.
Once that period is over, half of the 30 patients who participated in the outpatient exercise program will continue in the program and the other half will be randomized to independently continue to exercise.
The investigators hypothesize that exercising will benefit the patient by slowing the dementia process, improving behavioral symptoms, and decreasing volume loss of certain brain regions.
Each person will perform personalized exercise regimens, MR imaging and neuropsychological tests will be used to measure the benefits of exercise.
Ultimately, the hope is that the results of this study could be used to facilitate exercise programs for patients.
Enrollment is completely voluntary and all personal data obtained will remain confidential.
研究概览
研究类型
介入性
注册 (预期的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Ontario
-
Toronto、Ontario、加拿大、M5T 2S8
- 招聘中
- Toronto Western Hospital, WW5-449
-
首席研究员：
- Carmela Tartaglia, MD, FRCPC
-
接触：
- Carmela Tartaglia, MD, FRCPC
- 电话号码：416-603-5483
- 邮箱：carmela.tartaglia@uhn.ca
-
接触：
- Cassandra J. Anor, BSc 2015
- 电话号码：416-507-6880
- 邮箱：cassandra.anor@uhn.ca
-
副研究员：
- Mary Pat McAndrews, PhD
-
副研究员：
- Alison Lake, MSc, OT
-
副研究员：
- Mallar Chakravarty, PhD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
60年 至 95年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion criteria for patients will be as follows:
- Diagnosis of probable Alzheimer's disease as per 2011 criteria
- Mild or moderate stage of dementia, a score of 10-25 in the Clinical dementia rating score (CDR) <2 and a score of 10-25 (inclusive) on the Montreal Cognitive Assessment (MoCA)
- Age 60 to 95 inclusive
- Mobility, preserved vision and hearing (eyeglasses and/or hearing aid are permissible) sufficient for compliance with testing procedures
- Ability to tolerate and perform aerobic exercise program (as per The Canadian Society for Exercise Physiology; all patients above the age of 69 embarking on a new exercise routine should have the "Physical Activity Readiness Medical Examination" (PARmed-X) form completed by their family physician. All patients being asked to enroll in the study will have their PCPs fill out this form to ensure the patient is able to withstand the exercise program. If they are being followed by a cardiologist, they fill out the form)
- Presence of a respective caregiver
- Ability to tolerate MRI
- Ability to speak and understand the English language (as questionnaires and tests are only available in English)
Inclusion criteria for the caregivers will be as follows:
- Being the primary caregiver for a given patient
- Ability to speak and understand English (as questionnaires and tests are only available in English)
- MoCA score ≥ 26
Exclusion criteria for Patients and Caregivers:
- History of another neurological disorder
- Psychiatric disorder
- Severe aphasia (semantic word loss)
- Visual deficits requiring correction beyond the use of eyeglasses or contact lenses (intact visual acuity is required for completing both the questionnaires and the emotion evaluation test which consists of video vignettes)
- Hearing problems requiring correction beyond hearing aids (videos have an auditory component)
Exclusion Criteria for Patients:
- Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal pieces or objects in the eyes, skin or body will be excluded as they will be unable to have a MRI scan
- Inability to tolerate or perform aerobic exercise as declared by family physician on PARmed-X form
- Significant vascular disease seen on MRI (Fazekas score>2)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Normal Activity level
|
|
|
有源比较器：Personalized Exercise Regimen
|
All exercise regimens include a stationary bicycle.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Neuropsychological Test Battery
大体时间：Throughout first 6 months of patient participation
|
The test battery selected comprises of standardized, validated tests focusing on domains including: attention & concentration, executive functioning, learning and memory, visuospatial, language and semantic memory, pre-morbid intellectual functioning, and speed of processing.
|
Throughout first 6 months of patient participation
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Carmela Tartaglia, MD, FRCPC、Cognitive Neurologist at the Toronto Western Hospital Memory Clinic
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年8月1日
初级完成 (预期的)
2020年4月1日
研究完成 (预期的)
2020年4月1日
研究注册日期
首次提交
2013年8月23日
首先提交符合 QC 标准的
2013年8月29日
首次发布 (估计)
2013年9月4日
研究记录更新
最后更新发布 (实际的)
2019年9月25日
上次提交的符合 QC 标准的更新
2019年9月24日
最后验证
2019年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.