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临床试验/NCT02198872
NCT02198872Unknown早期 1 期

Effects of Aquatic and Land Aerobic Training on Body Composition and Cardiorespiratory and Metabolic Variables in Patients With Cardiorespiratory Diseases

Universidade Metodista de Piracicaba2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
早期 1 期
入组人数
40
试验地点
2
主要终点
Change in autonomic system modulation

研究概览

简要总结

In the pathophysiological process of coronary artery disease (CAD), are present, autonomic dysfunction and reduced functional capacity. Studies showed that physical training (PT) is critical in the treatment of CAD by promoting beneficial effects. Although water based exercises program have been documented in patients with various cardiovascular diseases, the most of studies among patients with CAD used land based exercises programs. OBJECTIVE: To evaluate and compare the effects of aerobic water (WPT) and land (LPT) based PT on autonomic modulation of heart rate (HR), body composition and cardiorespiratory and metabolic variables in patients with CAD. METHODS : 40 men between 50 and 70 years old with CAD diagnosed by coronary angiography showing obstruction greater than 50% and underwent angioplasty will be evaluated in 4 stages; 1) immediately after angioplasty, clinical assessment, body composition analysis and recording of HR and NN intervals during rest. 2) The components of step 1) will be repeated after three month, adding the record of HR and NN before, during and after the Valsalva maneuver, spirometry and cardiopulmonary exercise testing. 3) Volunteers will be randomly divided into two groups, WPT and LPT for 48 sessions. 4) The components of step 2) are repeated after each period of 12 sessions. Thus, it is expected that WPT promote beneficial physiological adaptations in CAD patients with obstruction greater than 50%.

详细描述

  1. Immediately after angioplasty, the volunteers will be subject to an assessment (Assessment 0), which will consist of:
  • History: personal data, lifestyle and food, family history, current and previous history of disease.
  • Physical examination: cardiac and lung auscultation,measurement of heart rate (HR), blood pressure (BP), body weight and height.
  • Analysis of body composition by bioelectrical impedance analysis.
  • Registration of HR and NN intervals (NN) during rest, in the supine and sitting positions.
  • biochemical blood tests: complete blood count, blood glucose, total cholesterol, LDL and HDL cholesterol, triglycerides, and C-reactive protein ultrasensitive.
  • Recording of HR and NN during rest in the supine position, sitting, standing and during respiratory sinus arrhythmia maneuver.
  1. Three months after the "Assessment 0", the volunteers will be subject to an assessment (initial Assessment) prior to physical training program. Will be repeated all assessments performed in the "Assessment 0" plus the record of HR and R-Ri before, during and after the Valsalva maneuver, spirometry and cardiopulmonary exercise test (CPET). This is a submaximal CPET performed on a treadmill, in order to verify and identify possible changes in hemodynamic, electrocardiographic induced to physical exertion, their aerobic functional capacity as well as to prescribe physical training protocol.
  2. After this assessment, the volunteers will be randomly assigned to one of two groups, aerobic water (WPT) or land (LPT) based physical training.
  3. Components of "Initial Assessment" will be repeated at the end of each month of physical training (Revaluation 1, 2 and 3) and the end (Final Assessment).

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • diagnosis by angiography
  • sedentaries
  • family story of cardiac disease

排除标准

  • frequent arrhythmias at rest
  • triggered by physical effort
  • unstable angina
  • chronic obstructive pulmonary disease
  • insulin-dependent diabet
  • renal failure
  • sequel of stroke
  • uncontrolled hypothyroidism
  • water phobia
  • skin infections, allergic reactions to chlorine,
  • urinary incontinence and
  • musculoskeletal and neuromuscular disorders precluding physical tests and training sessions

结局指标

主要结局

Change in autonomic system modulation

时间窗: baseline and 16 weeks

Change in autonomic system modulation in assess by comparing the heart rate variability at baseline and after a 16 weeks of aerobic water and land based physical training.

次要结局

  • Change in body composition(16 weeks)

研究者

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

Elie Fiogbé

Professor

Universidade Metodista de Piracicaba

研究点 (2)

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