Functional Inspiratory Muscle Training in Patients Diagnosed With Hypertension

Hypertension,Essential Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06343246
• Other study ID #: MustafaKemalU
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: March 2024
• Source: Mustafa Kemal University
• Contact: Irem Hüzmeli, PhD
• Phone: +903262455516
• Email: fztirem[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg,

2. It will include both male and female subjects aged =18 and <80 years with a previous diagnosis of essential hypertension.

3. Subjects receiving no pharmacological treatment or receiving only thiazide diuretics

4. 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:

1. Blood pressure =160 / 100 mmHg

2. Severe dyspnea; diabetes; orthopedic, musculoskeletal, or fitness limitations;

3. Major physiological crises;

4. A current or past history of deep venous thrombosis; History of myocardial infarction or stroke within the 5th year or 6 months ago;

6. Congestive heart therapy; 7. Unstable angina; 8. or lung disease of any etiology (including asthma and chronic obstructive pulmonary disease); 9. Active smokers 10. Patients under 18 years of age 11. Pregnant women 12. Those with Active Infection 13. Those with Known Malignancy

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension
• Hypertension,Essential
• Respiratory Aspiration

Intervention

Device:
• Inspiratory muscle training with device
: A randomized, controlled three-arm study. Forty-five patients with HT randomized three group: Group 1 will receive IMT (7 days/8 weeks) with function and POWERbreathe® Classic LR device, group 2 will reviece only IMT with 50 % maximal inspiratory pressure (MIP), n: 15) and control group will recieve breathing exercises(7 days/8 weeks).

Locations

Country	Name	City	State
Turkey	Hatay Mustafa Kemal University	Hatay	Antakya

Sponsors (1)

Lead Sponsor	Collaborator
Mustafa Kemal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the exercise capacity 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.	from baseline to 8 week
Primary	Change of the peripheral muscle strenght 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.	from baseline to 8 week
Primary	change of the upper extremity exercise capacity 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.	from baseline to 8 week
Secondary	change of the postural balance from baseline to 8 week	Timed Up and Go test (TUG): It measures the time it takes for the patient to get up from the chair, walk 3 m, turn around and sit down in the same chair again. The TUG test is a simple test used to evaluate postural mobility	from baseline to 8 week
Secondary	change of the physical activity from baseline to 8 week	Physical activity level was measured with the International Physical Activity Questionnaire (IPAQ). In this questionnaire, which provides information about the time spent in sitting, walking, moderately vigorous activities, and vigorous activities, the criterion for evaluating all activities is that each activity is performed for at least 10 minutes at a time.	from baseline to 8 week
Secondary	change of the quality of life from baseline to 8 week	SF-36 survey. In this scale, where health is examined in eight components, higher scores indicate a better level of health. SF-36 scale; physical functionality (limitation in physical activity due to health problems), physical role limitation in daily living activities due to health problems), bodily pain, general health (evaluation of the person's general health), vitality , general mental health, social functionality and emotional role (limitation in daily living activities due to mental health problems). The SF-36 scale is scored out of 100 points, and the scores vary between 0 and 100 points for each component.	from baseline to 8 week
Secondary	change of the Fev1/Fvc	Pulmonary function test will measure with a portable spirometer (SPIROBANK II® Moggiolino, Rome-Italy). The best of 3 technically acceptable maneuvers with 95% agreement will select and record	from baseline to 8 week