HypertensionNCT05517915
Inspiratory Muscle Training, Autonomic Dysfunction and Blood Pressure
A study testing Inspiratory muscle training. in people with Hypertension, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
This study finds the effectiveness of inspiratory muscle threshold loading training among adults with hypertension. A sample of hypertensive subjects was divided into two groups - inspiratory muscle training (IMT) - group (inspiratory muscle training was prescribed) and sham-group (no load was prescribed during IMT). Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Inspiratory muscle training.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 8 Jan 2018to 27 Aug 2018
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stage 1 hypertension
- essential hypertension
- mild hypertension
Who cannot join
- Subjects participating in exercise training for more than the last six months
- severe musculoskeletal limitations
- severe neurological limitations
- cognitive impairments
- uncontrolled diabetes
- uncontrolled hypertension
Show all 11Show fewer
- a history of myocardial infarction (MI)
- a history of stroke in the last six months
- unstable angina
- chronic heart failure
- pulmonary disease of any etiology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Interval Inspiratory Muscle Training on Autonomic Dysfunction and Blood Pressure in Hypertensive Adults: A Randomized Controlled Trial
This study finds the effectiveness of inspiratory muscle threshold loading training among adults with hypertension. A sample of hypertensive subjects was divided into two groups - inspiratory muscle training (IMT) - group (inspiratory muscle training was prescribed) and sham-group (no load was prescribed during IMT). Both groups had training sessions comprising seven cycles of two minutes bouts of breathing counter to an inspiratory load, each bout parted by one minute of unloaded recovery. Treatment session was performed for three times per week for a total of six weeks. Measurement of each of the variables (blood pressure, resting heart rate (RHR), heart rate variability (HRV)) was taken at baseline and after the six-week intervention.
Read the detailed description
The present study aimed to examine the outcome of interval inspiratory muscle training at 70% load on blood pressure, resting heart rate and autonomic dysfunction in the hypertensive adults.
Participants were divided into two groups: IMT and sham. In IMT group, the threshold loading inspiratory muscle trainer from POWERbreathe was used with 70% IMT threshold. In Sham group, IMT was unloaded.
- Conditions
- Hypertension
- Being tested
- Inspiratory muscle training., Sham inspiratory muscle training.
- Keywords
- Interval Inspiratory Muscle Training, Hypertension, Autonomic Dysfunction, Blood Pressure
- Medical subject headings
- Hypertension, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle training.Other
Interval inspiratory muscle training was performed using the inspiratory muscle trainer.
Sham inspiratory muscle training.Other
Interval inspiratory muscle training was performed using the unloaded inspiratory muscle trainer.
| Study group | Role | What they receive |
|---|---|---|
| IMT group | Experimental | IMT training with 70% threshold was given. Receives: Other: Inspiratory muscle training. |
| Sham group | Sham comparator | unloaded IMT training was given. Receives: Other: Sham inspiratory muscle training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting heart rate
Resting heart rate was measured at baseline and after completion of intervention.
Measured: 6 weeks
Autonomic functions
Autonomic functions were assessed by measuring the heart rate variability parameters at baseline and after completion of intervention.
Measured: 6 weeks
Blood pressure
Systolic and diastolic blood pressures were measured at baseline and after completion of intervention.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start8 Jan 2018
- Primary completion18 Jun 2018
- Study completion27 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Two group pretest-posttest parallel design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masood Khan, King Saud University
- Investigators
- Masood Khan, M.P.Th, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517915
- Sponsor's protocol ID
- 16/9/139/JMI/IEC/2017
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Interval Inspiratory Muscle Training on Autonomic Dysfunction and Blood Pressure in Hypertensive Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05517915
- Acronym / sponsor ID
- 16/9/139/JMI/IEC/2017
- Conditions
- Hypertension
- Keywords
- Interval Inspiratory Muscle Training, Hypertension, Autonomic Dysfunction, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 18 Jun 2018 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 26 Aug 2022 (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 finds the effectiveness of inspiratory muscle threshold loading training among adults with hypertension. A sample of hypertensive subjects was divided into two groups - inspiratory muscle training (IMT) - group (inspiratory muscle training was prescribed) and sham-group (no load was prescribed during IMT). Both groups had training sessions comprising seven cycles of two minutes bouts of breathing counter to an inspiratory load, each bout parted by one minute of unloaded recovery. Treatment session was performed for three times per week for a total of six weeks. Measurement of each of the variables (blood pressure, resting heart rate (RHR), heart rate variability (HRV)) was taken at baseline and after the six-week intervention.
Detailed description
The present study aimed to examine the outcome of interval inspiratory muscle training at 70% load on blood pressure, resting heart rate and autonomic dysfunction in the hypertensive adults.
Participants were divided into two groups: IMT and sham. In IMT group, the threshold loading inspiratory muscle trainer from POWERbreathe was used with 70% IMT threshold. In Sham group, IMT was unloaded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two group pretest-posttest parallel design.
| Arm | Type | Receives |
|---|---|---|
| IMT group | Experimental | Other: Inspiratory muscle training.IMT training with 70% threshold was given. |
| Sham group | Sham comparator | Other: Sham inspiratory muscle training.unloaded IMT training was given. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- stage 1 hypertension
- essential hypertension
- mild hypertension
Key exclusion criteria (11 listed)
- Subjects participating in exercise training for more than the last six months
- severe musculoskeletal limitations
- severe neurological limitations
- cognitive impairments
- uncontrolled diabetes
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.Interval inspiratory muscle training was performed using the inspiratory muscle trainer. | Other | IMT group |
| Sham inspiratory muscle training.Interval inspiratory muscle training was performed using the unloaded inspiratory muscle trainer. | Other | Sham group |
Primary outcome
Resting heart rate
Time frame: 6 weeks
Resting heart rate was measured at baseline and after completion of intervention.
Autonomic functions
Time frame: 6 weeks
Autonomic functions were assessed by measuring the heart rate variability parameters at baseline and after completion of intervention.
Blood pressure
Time frame: 6 weeks
Systolic and diastolic blood pressures were measured at baseline and after completion of intervention.
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 26 Aug 2022.
- 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.
Masood Khan, M.P.Th principal investigator
King Saud 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. in people with Hypertension, run by King Saud University at 1 site in Saudi Arabia.
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 3 inclusion and 11 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 26 Aug 2022. 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 Saudi Arabia. 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. Some participants in this study may receive a placebo. 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?
Resting heart rate (time frame: 6 weeks). 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?
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 26 Aug 2022.