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临床试验/NCT04103411
NCT04103411Unknown不适用

Effect of High-Intensity Interval Training Compared to Hydrochlorothiazide on Ambulatory Blood Pressure, Cardiovascular Health, Cognition and Mobility in Pre-Hypertensive Older Adults.

Anil Nigam2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年4月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
24h-Ambulatory Blood Pressure

研究概览

简要总结

The number of persons with hypertension is increasing and with it the number of related cardiovascular events and related functional or cognitive declines. While studies have suggested that physical activity, in particular, high-intensity interval training (HIIT), could be as efficient as the commonly used antihypertensive medications, no studies have actually compared their effects in the same population. This protocol will determine if HIIT is at least as efficient as hydrochlorothiazide in order to lower 24h-ambulatory blood pressure (BP) in prehypertensive older adults.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Age at consent ≥ 60 years;
  • Systolic Blood pressure measured through BPtru™ between SBP ≥ 120 mmHg and < 140 and or DBP ≥ 80 mmHg
  • Being able to sign the informed consent form

排除标准

  • Considered "highly active" according to the International Physical Activity Questionnaire
  • Practicing more than 20 min per week of High-Intensity Interval Training
  • Use of antihypertensive medication
  • Contraindication for the practice of intense physical activity
  • Functional limitations related to the exercise test and to intensive training
  • Cardiovascular pathology
  • Atrial fibrillation
  • Psychiatric or neurological disorder
  • Renal failure
  • MMSE score < 26
  • Persons benefiting of enhanced protection: persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection and patients in emergency situations.

研究组 & 干预措施

High Intensity Interval Training (HIIT)

Experimental

For the twelve weeks of intervention, participants will have three training sessions per week. Each session will be done on a cycle ergometer and will last approximately 40 minutes. Participants will be supervised by certified kinesiologists and their training programs will be revised every four weeks.

干预措施: 24h-Ambulatory Blood Pressure (Other)

HydroChloroThiazide

Active Comparator

For this group, participants have to take a diuretic (12,5 mg of Hydrochlorothiazide) daily prescribed by the doctor of this study, for twelve weeks. Participants should also maintain the same lifestyle habits that they had before the study.

干预措施: 24h-Ambulatory Blood Pressure (Other)

结局指标

主要结局

24h-Ambulatory Blood Pressure

时间窗: At baseline and after twelve weeks of intervention

The 24-hour ambulatory measure of the blood pressure (AMBP)

次要结局

  • Cardiovascular evaluation(Before and after twelve weeks of intervention)
  • Cognitive functions(Before and after twelve weeks of intervention)
  • Flow Mediated Dilatation (FMD)(Before and after twelve weeks of intervention)

研究者

发起方
Anil Nigam
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anil Nigam

MD, cardiologist

Montreal Heart Institute

研究点 (2)

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