Functional Inspiratory Muscle Training in Patients Diagnosed With Hypertension

NCT ID: NCT06343246

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-03-30

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

Conditions

Hypertension,Essential

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Functional IMT Group

Functional IMT Group (n:15) : will recieve functional inspiratory muscle training (exercise + 50% of MIP)

Group Type: EXPERIMENTAL

Inspiratory muscle training with device

Intervention Type: 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).

IMT Group

IMT Group I (n:15): will recieve inspiratory muscle training (50% of MIP )

Group Type: ACTIVE_COMPARATOR

Inspiratory muscle training with device

Intervention Type: 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).

Control group

Control group (n:15): will recieve breathing exercises training

Group Type: EXPERIMENTAL

Inspiratory muscle training with device

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mustafa Kemal University

OTHER

Sponsor Role: lead

Responsible Party

Irem Hüzmeli

Assistant Prof. PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

İrem Hüzmeli

Role: PRINCIPAL_INVESTIGATOR

Mustafa Kemal University

Locations

Hatay Mustafa Kemal University

Hatay, Antakya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Huzmeli I, Katayifci N, Abay B, Akkus O, Ozer AY. The effectiveness of functional inspiratory muscle training on exercise capacity and peripheral muscle strength in patients with essential hypertension: a three-arm randomized controlled trial. BMC Sports Sci Med Rehabil. 2025 Feb 28;17(1):29. doi: 10.1186/s13102-025-01082-w.

Reference Type: DERIVED

PMID: 40022256 (View on PubMed)

Other Identifiers

MustafaKemalU

Identifier Type: -

Identifier Source: org_study_id