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临床试验/NCT04275037
NCT04275037已完成不适用

The Hypotensive Effects of Home-Based Isometric Handgrip Training in Older Adults With Pre-Hypertension and Hypertension - The HoldAge Trial

University Institute of Maia19 个研究点 分布在 2 个国家目标入组 84 人开始时间: 2021年4月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
84
试验地点
19
主要终点
24h ambulatory blood pressure

研究概览

简要总结

New data suggests that isometric handgrip training (IHT) might become a novel tool in the treatment of hypertension. The main purpose of this research project is to evaluate the effects of home-based IHT on ambulatory blood pressure in older adults with pre-hypertension and hypertension. Eighty-four older adults with pre-hypertension and hypertension will be randomly distributed to one of three groups: home-based IHT, home-based aerobic exercise training (AET), or attention-control group (CON). Each intervention will have a total duration of 8 weeks. At baseline and after completing the intervention, patients will undergo the following evaluations: 24-hour ambulatory blood pressure, cardiorespiratory fitness, endothelial function, damage and repair, arterial stiffness, inflammatory biomarkers, autonomic function, physical activity levels, dietary intake and quality of life. A qualitative analysis will also be applied to enhance the understanding of the efficacy of this intervention from the patient's perspective.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Secondary Hypertension
  • Target Organ Damage
  • Coronary Artery Disease
  • Heart Failure
  • Any Previous Cardiovascular Event
  • Peripheral Artery Disease
  • Renal Failure
  • Chronic Obstructive Pulmonary Disease
  • Insulin Dependent Diabetes
  • Change of Antihypertensive Medication in the Past 4 Weeks Before Inclusion in the Study
  • Those Participating in Regular Physical Activity

研究组 & 干预措施

Aerobic Exercise Training

Active Comparator

The 8-week exercise program will include three sessions of aerobic exercise per week

干预措施: Aerobic Exercise Training (Other)

Isometric Handgrip Training

Experimental

The 8-week exercise program will include three sessions of isometric handgrip training per week

干预措施: Isometric Handgrip Training (Other)

Control Group

No Intervention

The control group will receive usual medical care

结局指标

主要结局

24h ambulatory blood pressure

时间窗: Change from baseline to 2 months

次要结局

  • Arterial Stiffness(Change from baseline to 2 months)
  • Inflamamtion(Change from baseline to 2 months)
  • Health-related quality of life(Change from baseline to 2 months)
  • Weekly physical activity sleep quality(Change from baseline to 2 months)
  • Endothelial function(Change from baseline to 2 months)
  • Endothelial cell repair/damage(Change from baseline to 2 months)
  • Aerobic fitness(Change from baseline to 2 months)
  • Intervention quality(two weeks after the intervention)
  • Sleep quality(Change from baseline to 2 months)

研究者

发起方
University Institute of Maia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alberto Alves

Assistant Professor

University Institute of Maia

研究点 (19)

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