跳至主要内容
临床试验/NCT02275377
NCT02275377Unknown不适用

Effects of Inspiratory Muscle Training on Blood Pressure Levels in Hypertensive Individuals: a Randomized Clinical Trial.

Hospital de Clinicas de Porto Alegre2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Levels of blood pressure (mmHg)

研究概览

简要总结

This research aims to evaluate the effects of inspiratory muscle training (IMT) on blood pressure, in inspiratory muscle mechanoreflex, autonomic cardiovascular control in subjects with hypertension.

详细描述

Patients with hypertension will be selected through the Outpatient Hypertension of the Hospital of Clinics de Porto Alegre, for convenience. Subsequently, patients will be subjected to test respiratory muscle strength (manometer), respiratory muscle resistance, cardiopulmonary exercise testing (maximum), evaluation of cardiac reflex sensitivity and autonomic control test and induction of inspiratory muscle mechanoreflex with occlusion plethysmography at baseline before the start of the training protocol. Patients will randomize inspiratory muscle training for 30 minutes a day, 7 days a week, for 8 weeks with muscle training device (PowerBreathe). There will be a weekly monitoring in the Clinical Research Center of the institution where the maximal inspiratory pressure (MIP) and respiratory training techniques will be reassessed and readjusted (40% of MIP). The control group will be submitted to respiratory training techniques with muscle training device (PowerBreathe) without load. After this period, all initial tests will be reassessed. A healthy control group study with 10 normotensive individuals will be included.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants will be selected from the medical records in search of Basic Health Unit and Hypertension Clinic - Hospital of Clinics of Porto Alegre (HCPA), Porto Alegre - RS:
  • Diagnosis of essential hypertension with systolic blood pressure ≥140 mmHg and / or diastolic blood pressure ≥ 90 mmHg without treatment or use of antihypertensive;
  • Only taking diuretics (monotherapy) or none;
  • Body mass index ≤ 29.9 kg / m²;
  • Not engaged in physical activity;
  • Inspiratory muscle strength ≥ 70% of predicted.
  • Inclusion of normotensive individuals with systolic blood pressure <130 mmHg and/or diastolic blood pressure <85 mmHg by ambulatory blood pressure monitoring (ABPM).

排除标准

  • Blood pressure ≥ 160/100 mmHg
  • Pregnant and lactating women;
  • Deep vein thrombosis; current or previous.
  • Diabetes mellitus;
  • Orthopedic impairments, musculoskeletal, neurological and / or cognitive impairment, or even other diseases that compromise participation in the proposed protocol;
  • Acute myocardial infarction within the last 6 months;
  • Hearth failure;
  • Angina pectoris;
  • Pulmonary impairment from any source;
  • Current smoking.

结局指标

主要结局

Levels of blood pressure (mmHg)

时间窗: 8 weeks

Ambulatory blood pressure monitoring (ABPM).

次要结局

  • Inspiratory muscle mechanoreflex(8 weeks)
  • Cardiopulmonary Capacity(8 weeks)
  • Autonomic cardiovascular control(8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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