Clinical trial NCT02275377: Effects of Inspiratory Muscle Training on Blood Pressure Levels in Hypertensive Individuals
Official title: Effects of Inspiratory Muscle Training on Blood Pressure Levels in Hypertensive Individuals: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: Breathing Exercises; Autonomic Control; Blood Pressure.
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2014-10-27
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Levels of blood pressure (mmHg)
timeFrame: 8 weeks
Secondary outcomes:
measure: Inspiratory muscle mechanoreflex
timeFrame: 8 weeks
measure: Cardiopulmonary Capacity
timeFrame: 8 weeks
measure: Autonomic cardiovascular control
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Leila Moreira
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Leila B Moreira, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Posser SR, Callegaro CC, Beltrami-Moreira M, Moreira LB. Effect of inspiratory muscle training with load compared with sham training on blood pressure in individuals with hypertension: study protocol of a double-blind randomized clinical trial. Trials. 2016 Aug 2;17:382. doi: 10.1186/s13063-016-1514-y.