Effects of Inspiratory Muscle Training on Blood Pressure Levels in Hypertensive Individuals

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-12-31

Brief Summary

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This research aims to evaluate the effects of inspiratory muscle training (IMT) on blood pressure, in inspiratory muscle mechanoreflex, autonomic cardiovascular control in subjects with hypertension.

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Detailed Description

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Patients with hypertension will be selected through the Outpatient Hypertension of the Hospital of Clinics de Porto Alegre, for convenience. Subsequently, patients will be subjected to test respiratory muscle strength (manometer), respiratory muscle resistance, cardiopulmonary exercise testing (maximum), evaluation of cardiac reflex sensitivity and autonomic control test and induction of inspiratory muscle mechanoreflex with occlusion plethysmography at baseline before the start of the training protocol. Patients will randomize inspiratory muscle training for 30 minutes a day, 7 days a week, for 8 weeks with muscle training device (PowerBreathe). There will be a weekly monitoring in the Clinical Research Center of the institution where the maximal inspiratory pressure (MIP) and respiratory training techniques will be reassessed and readjusted (40% of MIP). The control group will be submitted to respiratory training techniques with muscle training device (PowerBreathe) without load. After this period, all initial tests will be reassessed. A healthy control group study with 10 normotensive individuals will be included.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Inspiratory muscle training (IMT)

Participants will be submitted to a linear pressure resistance (PowerBreathe) with an inspiratory load of 40% of maximal inspiratory pressure (adjusted weekly), seven days a week, session duration of 30 minutes for 8 weeks.

Group Type EXPERIMENTAL

Inspiratory muscle training (IMT)

Intervention Type OTHER

Participants will receive IMT for 30 min, 7 times per week for 8 weeks using Inspiratory muscle trainer device (PowerBreathe). During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min. Inspiratory load will be set at 40% of maximum static inspiratory pressure, and weekly training loads will be adjusted to maintain 40% of MIP. Each week, six training sessions will be held at home and a training session will be supervised in the research center.

Sham IMT

Participants will be submitted to inspiratory muscle training with the same equipment as the intervention group, but without a load generating resistance.

Group Type PLACEBO_COMPARATOR

Sham IMT

Intervention Type OTHER

Participants will receive IMT for 30 min, 7 times per week for 8 weeks using Inspiratory muscle trainer device (PowerBreathe). During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min, but without a load generating resistance. Each week, six training sessions will be held at home and a training session will be supervised in the research center.

Normotensive

The normotensive control group (healthy) will go through the same initial evaluation without performing inspiratory muscle training.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Inspiratory muscle training (IMT)

Participants will receive IMT for 30 min, 7 times per week for 8 weeks using Inspiratory muscle trainer device (PowerBreathe). During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min. Inspiratory load will be set at 40% of maximum static inspiratory pressure, and weekly training loads will be adjusted to maintain 40% of MIP. Each week, six training sessions will be held at home and a training session will be supervised in the research center.

Intervention Type OTHER

Sham IMT

Participants will receive IMT for 30 min, 7 times per week for 8 weeks using Inspiratory muscle trainer device (PowerBreathe). During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min, but without a load generating resistance. Each week, six training sessions will be held at home and a training session will be supervised in the research center.

Intervention Type OTHER

Other Intervention Names

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Inspiratory muscle training Sham Inspiratory muscle training

Eligibility Criteria

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Inclusion Criteria

Participants will be selected from the medical records in search of Basic Health Unit and Hypertension Clinic - Hospital of Clinics of Porto Alegre (HCPA), Porto Alegre - RS:

* Diagnosis of essential hypertension with systolic blood pressure ≥140 mmHg and / or diastolic blood pressure ≥ 90 mmHg without treatment or use of antihypertensive;
* Only taking diuretics (monotherapy) or none;
* Body mass index ≤ 29.9 kg / m²;
* Not engaged in physical activity;
* Inspiratory muscle strength ≥ 70% of predicted.

* Inclusion of normotensive individuals with systolic blood pressure \<130 mmHg and/or diastolic blood pressure \<85 mmHg by ambulatory blood pressure monitoring (ABPM).

Exclusion Criteria

* Blood pressure ≥ 160/100 mmHg
* Pregnant and lactating women;
* Deep vein thrombosis; current or previous.
* Diabetes mellitus;
* Orthopedic impairments, musculoskeletal, neurological and / or cognitive impairment, or even other diseases that compromise participation in the proposed protocol;
* Acute myocardial infarction within the last 6 months;
* Hearth failure;
* Angina pectoris;
* Pulmonary impairment from any source;
* Current smoking.

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes