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Inspiratory Muscle Training, Autonomic Dysfunction and Blood Pressure

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Inspiratory muscle training.
Sham inspiratory muscle training.
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Interval Inspiratory Muscle Training, Hypertension, Autonomic Dysfunction, Blood Pressure

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King Saud University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

IMT group

Sham group

Arm Description

IMT training with 70% threshold was given.

unloaded IMT training was given.

Outcomes

Primary Outcome Measures

Resting heart rate
Resting heart rate was measured at baseline and after completion of intervention.
Autonomic functions
Autonomic functions were assessed by measuring the heart rate variability parameters at baseline and after completion of intervention.
Blood pressure
Systolic and diastolic blood pressures were measured at baseline and after completion of intervention.

Secondary Outcome Measures

Full Information

First Posted
August 24, 2022
Last Updated
August 24, 2022
Sponsor
King Saud University
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1. Study Identification

Unique Protocol Identification Number
NCT05517915
Brief Title
Inspiratory Muscle Training, Autonomic Dysfunction and Blood Pressure
Official Title
Effect of Interval Inspiratory Muscle Training on Autonomic Dysfunction and Blood Pressure in Hypertensive Adults: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
June 18, 2018 (Actual)
Study Completion Date
August 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Interval Inspiratory Muscle Training, Hypertension, Autonomic Dysfunction, Blood Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two group pretest-posttest parallel design.
Masking
Outcomes Assessor
Masking Description
Outcome assessor was kept blind to the allocation of participants.
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMT group
Arm Type
Experimental
Arm Description
IMT training with 70% threshold was given.
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
unloaded IMT training was given.
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training.
Intervention Description
Interval inspiratory muscle training was performed using the inspiratory muscle trainer.
Intervention Type
Other
Intervention Name(s)
Sham inspiratory muscle training.
Intervention Description
Interval inspiratory muscle training was performed using the unloaded inspiratory muscle trainer.
Primary Outcome Measure Information:
Title
Resting heart rate
Description
Resting heart rate was measured at baseline and after completion of intervention.
Time Frame
6 weeks
Title
Autonomic functions
Description
Autonomic functions were assessed by measuring the heart rate variability parameters at baseline and after completion of intervention.
Time Frame
6 weeks
Title
Blood pressure
Description
Systolic and diastolic blood pressures were measured at baseline and after completion of intervention.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masood Khan, M.P.Th
Organizational Affiliation
King Saud University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Saud University
City
Riyadh
ZIP/Postal Code
11433
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

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Inspiratory Muscle Training, Autonomic Dysfunction and Blood Pressure

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