Inspiratory Muscle Training, Autonomic Dysfunction and Blood Pressure

NCT05517915 | Completed

• 1 other identifier: 16/9/139/JMI/IEC/2017
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Interval Inspiratory Muscle Training; Hypertension; Autonomic Dysfunction; Blood Pressure

Outcome Measures

Primary Outcomes (3)

• Resting heart rate

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

  6 weeks

• Autonomic functions

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

  6 weeks

• Blood pressure

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

  6 weeks

Study Arms (2)

IMT group

EXPERIMENTAL

IMT training with 70% threshold was given.

Other: Inspiratory muscle training.

Sham group

SHAM COMPARATOR

unloaded IMT training was given.

Other: Sham inspiratory muscle training.

Interventions

Inspiratory muscle training. OTHER

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

IMT group

Sham inspiratory muscle training. OTHER

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

Sham group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stage 1 hypertension
• essential hypertension
• mild hypertension

You may not qualify if:

• 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

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

King Saud University

Riyadh, 11433, Saudi Arabia

Location

MeSH Terms

Conditions

Hypertension; Primary Dysautonomias

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Autonomic Nervous System Diseases; Nervous System Diseases

Study Officials

• Masood Khan, M.P.Th

  King Saud University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor was kept blind to the allocation of participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two group pretest-posttest parallel design.

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: January 8, 2018
• Primary Completion: June 18, 2018
• Study Completion: August 27, 2018
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)