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Completed

NCT Number: NCT05517915

Inspiratory Muscle Training, Autonomic Dysfunction and Blood Pressure

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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Saud University

Riyadh, 11433, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • stage 1 hypertension
  • essential hypertension
  • mild hypertension

Exclusion criteria

  • Subjects participating in exercise training for more than the last six months
  • severe musculoskeletal limitations
  • severe neurological limitations
  • cognitive impairments
  • uncontrolled diabetes
  • uncontrolled hypertension
  • 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

Treatment and study plan

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.

Primary outcomes

  1. Resting heart rate

    Time frame: 6 weeks

    Resting heart rate was measured at baseline and after completion of intervention.

  2. Autonomic functions

    Time frame: 6 weeks

    Autonomic functions were assessed by measuring the heart rate variability parameters at baseline and after completion of intervention.

  3. Blood pressure

    Time frame: 6 weeks

    Systolic and diastolic blood pressures were measured at baseline and after completion of intervention.

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Official study title

Effect of Interval Inspiratory Muscle Training on Autonomic Dysfunction and Blood Pressure in Hypertensive Adults: A Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 26, 2022
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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