Inspiratory Muscle Training, Autonomic Dysfunction and Blood Pressure

NCT ID: NCT05517915

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-08
• Study Completion Date: 2018-08-27

Brief 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). 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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

IMT group

IMT training with 70% threshold was given.

Group Type: EXPERIMENTAL

Inspiratory muscle training.

Intervention Type: OTHER

Interval inspiratory muscle training was performed using the inspiratory muscle trainer.

Sham group

unloaded IMT training was given.

Group Type: SHAM_COMPARATOR

Sham inspiratory muscle training.

Intervention Type: OTHER

Interval inspiratory muscle training was performed using the unloaded inspiratory muscle trainer.

Interventions

Inspiratory muscle training.

Interval inspiratory muscle training was performed using the inspiratory muscle trainer.

Intervention Type: OTHER

Sham inspiratory muscle training.

Interval inspiratory muscle training was performed using the unloaded inspiratory muscle trainer.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Saud University

OTHER

Sponsor Role: lead

Responsible Party

Masood Khan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Masood Khan, M.P.Th

Role: PRINCIPAL_INVESTIGATOR

King Saud University

Locations

King Saud University

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

16/9/139/JMI/IEC/2017

Identifier Type: -

Identifier Source: org_study_id