Inspiratory Muscle Training, Autonomic Dysfunction and Blood Pressure

August 24, 2022 updated by: Masood Khan, King Saud University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11433
        • King Saud University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMT group
IMT training with 70% threshold was given.
Other: Inspiratory muscle training.
Interval inspiratory muscle training was performed using the inspiratory muscle trainer.
Sham Comparator: Sham group
unloaded IMT training was given.
Other: Sham inspiratory muscle training.
Interval inspiratory muscle training was performed using the unloaded inspiratory muscle trainer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting heart rate
Time Frame: 6 weeks
Resting heart rate was measured at baseline and after completion of intervention.
6 weeks
Autonomic functions
Time Frame: 6 weeks
Autonomic functions were assessed by measuring the heart rate variability parameters at baseline and after completion of intervention.
6 weeks
Blood pressure
Time Frame: 6 weeks
Systolic and diastolic blood pressures were measured at baseline and after completion of intervention.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Saud University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2018

Primary Completion (Actual)

June 18, 2018

Study Completion (Actual)

August 27, 2018

Study Registration Dates

First Submitted

August 24, 2022

First Submitted That Met QC Criteria

August 24, 2022

First Posted (Actual)

August 26, 2022

Study Record Updates

Last Update Posted (Actual)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/9/139/JMI/IEC/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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