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临床试验/NCT06243224
NCT06243224已完成不适用

The Effect Of High Intensity Interval Training And Moderate Intensity Continuous Training On Cardiopulmonary Parameters And Clinical Findings In Patients With Hypertension:A Randomized Comparative Study

Ankara City Hospital Bilkent2 个研究点 分布在 2 个国家目标入组 38 人开始时间: 2023年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
Aerobic capasity

研究概览

简要总结

Comparison of high intensity interval training (HIIT) and moderate intensity continuous training (MICT) in patients with hypertension patient in terms of aerobic capacity, blood pressure level, anxiety and depression scores, quality of life, kinesiophobia levels and sleep quality measurement.

详细描述

After being informed about study and potential risks, all patients giving written informed consent will undergo screening period determine eligibility for study entry. The patients who met the eligibility recruitments will get into the assessment. The study will include 38 participants (19 HIIT and 19 MICT). Stratified randomization method will be preferred in this study.A total of 38 patients with primary hypertension will be included in the study to evaluate the effect of different intensities of aerobic exercise on cardiopulmonary parameters, aerobic capacity, blood pressure level, anxiety and depression scores, quality of life, kinesiophobia levels and sleep quality.The researcher will record demographic and clinical data of the patients.All patients will be randomly divided into two groups as MICT (n=19) and HIIT (n=19) group. All patients will be evaluated with BDI (Beck Depression Inventory), BAI (Beck Anxiety Inventory), SF-36 (Short Form-36), KCS (Kinesiophobia Causes Scalae), PSQI (Pittsburgh Sleep Quality Index) before starting the rehabilitation program. Cardiopulmonary exercise test (CPET) will be performed to analyze the cardiopulmonary parameters and determine exercise capacity of the patients.The exercise prescription will be tailored in two different intensities according to the VO2 max (maximum oxygen uptake) values of the patients (HIIT and MICT).For determination of exercise intensity, KPET will be applied to all patients using the Sentry Suite Version 2.19 program with the device (CareFusion Type Master Screen PFT, Serial no: 672819, Germany) at Ankara Bilkent City Hospital. Moderate intensity will be calculated based on load (watt) at % 50-60 of VO2 max, high intensity will be calculated based on load (watt) at % 75-85 of VO2 max analyzed during the CPET. The aerobic exercise program will be performed with a horizontal ergometric bicycle for 3 sessions per week, each session being 30 minutes, for a total of 12 sessions for 4 weeks in the cardiopulmonary rehabilitation laboratory. At the end of the rehabilitation program, all these parameters will be re-evaluated and analyzed in the two groups and the two groups will be compared in terms of these parameters.

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 (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Being diagnosed with Isolated Hypertension
  • Being cognitively competent
  • Being between the ages of 35-55
  • Having given informed consent to participate in the study.

排除标准

  • Clinical heart failure
  • Uncontrolled hypertension
  • Secondary hypertension
  • Moderate or severe pulmoner disease
  • Symptomatic peripheral arterial disease
  • Unstable arrhythmia
  • Unstable or severe angina
  • Moderate or severe valvular heart disease
  • Cognitive limitation unable to understand the research protocol
  • Pace maker presence
  • Language problem
  • Autonomic neuropathy
  • Cardiomyopathy
  • Congenital heart disease
  • Recent history of stroke
  • Diabetes mellitus
  • Severe musculoskeletal disease causing exercise limitation
  • Being unable to continue treatment (3 days a week for 4 weeks)

结局指标

主要结局

Aerobic capasity

时间窗: baseline and at 4rd weeks

The aim of this study was to demonstrate the effects of aerobic exercise on aerobic capacity in patients with hypertension.The primary outcome is the change in maksimum oxygen consumption (VO2 max: mL.kg-1.min-1) between baseline and week 4 measured during CPET. Aerobic capacity is a measure of the functional capacity of the cardiorespiratory system and can be expressed as VO2 max (ml O2/kg/min). VO2 max is the amount of oxygen consumed in milliliters per kilogram per minute. The most accurate and reliable measure of aerobic capacity is the measurement of maximum oxygen consumption (VO2 max), which is the maximum volume of oxygen the body can take up and use during exercise. An increase in VO2 max is the most reliable method of demonstrating the effect of exercise.

次要结局

未报告次要终点

研究者

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

Nurdan Metin

Medical Doctor (Physical Medicine and Rehabilitation Resident Doctor)

Ankara City Hospital Bilkent

研究点 (2)

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