Inspiratory Muscle Training, Autonomic Dysfunction and Blood Pressure

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05517915
• Other study ID #: 16/9/139/JMI/IEC/2017
• Status: Completed
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: August 27, 2018

Study information

• Verified date: August 2022
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 27, 2018
• Est. primary completion date: June 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Hypertension
• Primary Dysautonomias
• Respiratory Aspiration

Intervention

Other:
• Inspiratory muscle training.
Interval inspiratory muscle training was performed using the inspiratory muscle trainer.
• Sham inspiratory muscle training.
Interval inspiratory muscle training was performed using the unloaded inspiratory muscle trainer.

Locations

Country	Name	City	State
Saudi Arabia	King Saud University	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

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