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临床试验/NCT06343246
NCT06343246已完成不适用

The Effect of Functional Inspiratory Muscle Training on Exercise Capacity, Peripheral Muscle Strength in Patients With Hypertension

Mustafa Kemal University2 个研究点 分布在 2 个国家目标入组 45 人开始时间: 2023年5月1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
45
试验地点
2
主要终点
Change of the peripheral muscle strenght from baseline to 8 week

研究概览

简要总结

This study was planned to investigate the effectiveness of combined exercise training, that is, functional inspiratory muscle training, with breathing exercises to be applied with a portable, easy-to-use respiratory muscle strengthening device, on exercise capacity and peripheral muscle strength.

详细描述

Forty-five Individuals will be randomly divided into three groups:

Functional IMT Group (n:15): will receive functional inspiratory muscle training (exercise + 50% of MIP) IMT Group I (n:15): will recieve inspiratory muscle training (50% of MIP ) Control group (n:15): will recieve breathing exercises training

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

入选标准

  • Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg,
  • It will include both male and female subjects aged ≥18 and <80 years with a previous diagnosis of essential hypertension.
  • Subjects receiving no pharmacological treatment or receiving only thiazide diuretics
  • Those with a body mass index <30 kg/m2 Those who engage in <150 minutes of moderate or intense physical activity per week, according to the 5th International Physical Activity Survey

排除标准

  • Blood pressure ≥160 / 100 mmHg
  • Severe dyspnea; diabetes; orthopedic, musculoskeletal, or fitness limitations;
  • Major physiological crises;
  • A current or past history of deep venous thrombosis; History of myocardial infarction or stroke within the 5th year or 6 months ago;
  • Congestive heart therapy;
  • Unstable angina;
  • or lung disease of any etiology (including asthma and chronic obstructive pulmonary disease);
  • Active smokers
  • Patients under 18 years of age
  • Pregnant women
  • Those with Active Infection
  • Those with Known Malignancy

结局指标

主要结局

Change of the peripheral muscle strenght from baseline to 8 week

时间窗: from baseline to 8 week

Peripheral muscle strength and hand grip strength were evaluated with a portable dynamometer and the values obtained were recorded in Newton (N)/kgF/Pascal. Peripheral muscle strength was measured seated, employing a hand-held dynamometer (JTECH Power Track Commander, Baltimore, MD, USA). This device, known for its portability and cost-effectiveness, serves as an alternative to isokinetic machines and offers greater sensitivity in detecting changes in muscle strength compared to manual muscle tests. Respiratory muscle strength 'maximum inspiratory pressure (MIP) and expiratory pressure (MEP)' will calculate with a portable, electronic mouth pressure measuring device.

Change of the exercise capacity from baseline to 8 week

时间窗: from baseline to 8 week

Exercise capacity was evaluated with the 6-Minute Walk Test (6MWT). ATS (American Thoracic Society) criteria were taken into consideration and the subjects rested for at least half an hour before starting the test. Participants walked briskly at their own walking pace for 6 minutes on a 30-meter straight corridor. The distance reached at the end of the test was recorded in meters.

change of the upper extremity exercise capacity from baseline to 8 week

时间窗: from baseline to 8 week

6PBRT is a test used to evaluate unsupported upper extremity exercise capacity. Participants will be asked to sit in an adjustable-height chair. The pegboard will be placed within arm's reach of the person. Participants will be asked to attach a total of 20 rings, 32 rings, 10 on each iron rod, located at both shoulder levels, to the iron rods 20 centimeters above, as quickly as possible, using both arms simultaneously, for six minutes, and then to attach and remove them again to the iron rods below.

次要结局

  • change of the Fev1/Fvc(from baseline to 8 week)
  • change of the postural balance from baseline to 8 week(from baseline to 8 week)
  • change of the physical activity from baseline to 8 week(from baseline to 8 week)
  • change of the quality of life from baseline to 8 week(from baseline to 8 week)

研究者

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

Irem Hüzmeli

Assistant Prof. PhD

Mustafa Kemal University

研究点 (2)

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