Clinical trial NCT06343246: Functional Inspiratory Muscle Training in Patients Diagnosed With Hypertension
Official title: The Effect of Functional Inspiratory Muscle Training on Exercise Capacity, Peripheral Muscle Strength in Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension,Essential
Keywords: exercise
peripheric muscle strenght
inspiratory muscle training
high blood pressure
functionality
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Randomized Controlled Study
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change of the exercise capacity from baseline to 8 week
timeFrame: from baseline to 8 week
measure: Change of the peripheral muscle strenght from baseline to 8 week
timeFrame: from baseline to 8 week
measure: change of the upper extremity exercise capacity from baseline to 8 week
timeFrame: from baseline to 8 week
Secondary outcomes:
measure: change of the postural balance from baseline to 8 week
timeFrame: from baseline to 8 week
measure: change of the physical activity from baseline to 8 week
timeFrame: from baseline to 8 week
measure: change of the quality of life from baseline to 8 week
timeFrame: from baseline to 8 week
measure: change of the Fev1/Fvc
timeFrame: from baseline to 8 week
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: Hatay Mustafa Kemal University
state: Antakya
Study officials:
affiliation: Mustafa Kemal University
name: İrem Hüzmeli
role: PRINCIPAL_INVESTIGATOR
References: