Hypertension,EssentialNCT06343246
Functional Inspiratory Muscle Training in Patients Diagnosed With Hypertension
A study testing Inspiratory muscle training with device in people with Hypertension,Essential, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension,Essential
- What is being tested?
- Inspiratory muscle training with device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Inspiratory muscle training with device
- Keywords
- exercise, peripheric muscle strenght, inspiratory muscle training, high blood pressure, functionality
- Medical subject headings
- Essential Hypertension, Motor Activity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle training with deviceDevice
: 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).
| Study group | Role | What they receive |
|---|---|---|
| Functional IMT Group | Experimental | Functional IMT Group (n:15) : will recieve functional inspiratory muscle training (exercise + 50% of MIP) Receives: Device: Inspiratory muscle training with device |
| IMT Group | Active comparator | IMT Group I (n:15): will recieve inspiratory muscle training (50% of MIP ) Receives: Device: Inspiratory muscle training with device |
| Control group | Experimental | Control group (n:15): will recieve breathing exercises training Receives: Device: Inspiratory muscle training with device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: from baseline to 8 week
Secondary outcomes (4)
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: from baseline to 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 May 2023
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Controlled Study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irem Hüzmeli, Mustafa Kemal University
- Investigators
- İrem Hüzmeli, Principal investigator, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343246
- Sponsor's protocol ID
- MustafaKemalU
- Status last verified
- Aug 2024
- First submitted
- 19 Mar 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40022256
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Functional Inspiratory Muscle Training on Exercise Capacity, Peripheral Muscle Strength in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT06343246
- Acronym / sponsor ID
- MustafaKemalU
- Conditions
- Hypertension,Essential
- Keywords
- exercise, peripheric muscle strenght, inspiratory muscle training, high blood pressure, functionality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Functional IMT Group | Experimental | Device: Inspiratory muscle training with deviceFunctional IMT Group (n:15) : will recieve functional inspiratory muscle training (exercise + 50% of MIP) |
| IMT Group | Active comparator | Device: Inspiratory muscle training with deviceIMT Group I (n:15): will recieve inspiratory muscle training (50% of MIP ) |
| Control group | Experimental | Device: Inspiratory muscle training with deviceControl group (n:15): will recieve breathing exercises training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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;
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Control group, Functional IMT Group, IMT Group |
Primary outcome
Change of the exercise capacity from baseline to 8 week
Time frame: 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.
Change of the peripheral muscle strenght from baseline to 8 week
Time frame: 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.
change of the upper extremity exercise capacity from baseline to 8 week
Time frame: 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.
4 secondary outcomes
change of the postural balance from baseline to 8 week
Time frame: from baseline to 8 week
change of the physical activity from baseline to 8 week
Time frame: from baseline to 8 week
change of the quality of life from baseline to 8 week
Time frame: from baseline to 8 week
change of the Fev1/Fvc
Time frame: from baseline to 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Derived from this study: PubMed 40022256Huzmeli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İrem Hüzmeli principal investigator
Mustafa Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training with device in people with Hypertension,Essential, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the exercise capacity from baseline to 8 week (time frame: from baseline to 8 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06343246, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.