Functional Inspiratory Muscle Training in Patients Diagnosed With Hypertension

NCT06343246 | Completed

• 1 other identifier: MustafaKemalU
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension,Essential

Keywords

exercise; peripheric muscle strenght; inspiratory muscle training; high blood pressure; functionality

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

• change of the Fev1/Fvc

  from baseline to 8 week

Study Arms (3)

Functional IMT Group

EXPERIMENTAL

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

Device: Inspiratory muscle training with device

IMT Group

ACTIVE COMPARATOR

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

Device: Inspiratory muscle training with device

Control group

EXPERIMENTAL

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

Device: Inspiratory muscle training with device

Interventions

Inspiratory muscle training with device 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; Functional IMT Group; IMT Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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; 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

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (1)

Hatay Mustafa Kemal University

Hatay, Antakya, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40022256 DERIVED

MeSH Terms

Conditions

Essential Hypertension; Motor Activity; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• İrem Hüzmeli

  Mustafa Kemal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof. PhD

Model Details: Prospective Randomized Controlled Study

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 2, 2024
• Study Start: May 1, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)