Functional Inspiratory Muscle Training in Patients Diagnosed With Hypertension

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension,Essential
• Intervention / Treatment: Device: Inspiratory muscle training with device

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

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Antakya
    • Hatay, Antakya, Turkey
      • Hatay Mustafa Kemal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional IMT Group; Functional IMT Group (n:15) : will recieve functional inspiratory muscle training (exercise + 50% of MIP)	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).
Active Comparator: IMT Group; IMT Group I (n:15): will recieve inspiratory muscle training (50% of MIP )	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).
Experimental: Control group; Control group (n:15): will recieve breathing exercises training	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Mustafa Kemal University
• Investigators: Principal Investigator: İrem Hüzmeli, Mustafa Kemal University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): March 30, 2024

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: exercise; functionality; inspiratory muscle training; high blood pressure; peripheric muscle strenght
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Hypertension; Respiratory Aspiration; Essential Hypertension
• Other Study ID Numbers: MustafaKemalU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No