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Clinical Trials/NCT06343246
NCT06343246
Completed
Not Applicable

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

Mustafa Kemal University1 site in 1 country45 target enrollmentMay 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension,Essential
Sponsor
Mustafa Kemal University
Enrollment
45
Locations
1
Primary Endpoint
Change of the peripheral muscle strenght from baseline to 8 week
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
May 1, 2023
End Date
March 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Irem Hüzmeli

Assistant Prof. PhD

Mustafa Kemal University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Change of the peripheral muscle strenght from baseline to 8 week

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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