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临床试验/NCT03158337
NCT03158337招募中不适用

Effects of Regular Exercise on Cerebrovascular Reserve in Older Adults: Role in the Prevention of Age-Related Cognitive Decline

University of Calgary2 个研究点 分布在 1 个国家目标入组 286 人开始时间: 2010年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
286
试验地点
2
主要终点
Change in Cognition Assessed by Neuropsychological Test Battery

研究概览

简要总结

While it is well established that physical inactivity is a modifiable risk factor for vascular disease and cognitive decline, the mechanism by which exercise exerts its protective effect on the cerebral circulation and cognition is unknown. This knowledge gap was recognized recently in the Centers for Disease Control & Prevention and the Alzheimer's Association document "National Public Health Road Map to Maintaining Cognitive Health". Our rationale for these studies is that the identification of physical exercise as a lifestyle factor able to improve cerebrovascular reserve and cognition would establish a strong scientific framework justifying design of a randomized clinical trial that could evaluate the role of physical activity in cerebrovascular health and function.

This research is based on data we obtained from a cross-sectional study that showed significant relations between physical fitness, vascular regulation and cognition. Cerebrovascular reserve and cognition were better maintained in women who were physically active but reduced in women who were sedentary. Our central hypothesis is that regular aerobic exercise mitigates age-related decreases in cerebrovascular reserve, which in turn imparts benefits in cognition. Further, we believe that these effects will persist after the structured aerobic exercise program is terminated.

Our 18 month study began with a 6-month baseline period, followed by a 6-month exercise intervention, and a 6-month follow-up period. In addition, there are 5-year and 10-year follow-up periods. Volunteers (men and women aged ≥ 55 years) from the community were recruited using a variety of recruitment methods including media and distribution lists. After the baseline (pre-training) measurements, participants underwent a six-month aerobic training program, following guidelines previously used by us and according to the new exercise guidelines for older adults established by American College of Sports Medicine and the American Heart Association. The study involves comprehensive assessments of physical fitness, cerebrovascular responses to carbon dioxide at rest and during sub-maximal exercise, and an extensive battery of cognitive function tests.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • sedentary status (engages in less than 30 minutes of moderate exercise four days per week or 20 continuous minutes of vigorous exercise two days per week), the ability to walk independently outside or on stairs, body mass index (BMI) < 35 kg/m^2, women were at least 12 months postmenopausal on entry into the study

排除标准

  • heart/chest pain upon physical exertion, fainting spells/dizziness, surgery or major trauma in the previous 6 months, known asthma or sleep apnea, history of myocardial infarction, angina, arrhythmia, valve disease, chronic heart failure, history of stroke, cardiovascular or cerebrovascular disease, history of chronic headache or migraines, history of blood clots/thrombosis, smokers (within last 12 months), currently taking medication (beta-blockers, anti-depressants, digitalis/digoxin, blood thinners (warfarin), evista (raloxifene), corticosteroids (e.g., prednisone), adrenaline/epinephrine, anti-arrhythmics (e.g., norpace)).

结局指标

主要结局

Change in Cognition Assessed by Neuropsychological Test Battery

时间窗: Measured at baseline (0 and 6 months), exercise intervention completion (12 months) and follow up (18,72 and 132 months)

次要结局

  • Change in Blood Biomarkers Assessed by Elisa Assays(Measured at baseline (0 and 6 months), during the exercise intervention (9 months), exercise intervention completion (12 months) and follow up (18,72 and 132 months))
  • Change in Risk/protective factors Assessed by Questionnaires(Measured at baseline (0 and 6 months), during the exercise intervention (9 months), exercise intervention completion (12 months) and follow up (18,72 and 132 months))
  • Change in Maximal Oxygen Uptake (VO2max) Assessed by Metabolic Cart(Measured at baseline (0 and 6 months), during the exercise intervention (9 months), exercise intervention completion (12 months) and follow up (18,72 and 132 months))
  • Change in Cerebral Blood Flow Assessed by Transcranial Doppler Ultrasound(Measured at baseline (0 and 6 months), during the exercise intervention (9 months), exercise intervention completion (12 months) and follow up (18,72 and 132 months))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marc Poulin

Professor

University of Calgary

研究点 (2)

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