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

Hypertension Clinical Trial

Official title:

Effects of Inspiratory Muscle Training on Blood Pressure Levels in Hypertensive Individuals: a Randomized Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02275377
• Other study ID #: 14-0405
• Status: Recruiting
• Phase: N/A
• First received: September 30, 2014
• Last updated: May 18, 2015
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2015
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Leila B Moreira, PhD
• Phone: +55 51 33597695
• Email: lbmoreira[@]hcpa.ufrgs.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Leila Moreira	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of blood pressure (mmHg)	Ambulatory blood pressure monitoring (ABPM).	8 weeks	No
Secondary	Inspiratory muscle mechanoreflex	Venous occlusion plethysmography measure during inspiratory muscle training exercise at 60% and 2% of maximal inspiratory muscle strength.	8 weeks	No
Secondary	Cardiopulmonary Capacity	High-intensity exercise test (maximum) assessed by ergometry with noninvasive hemodynamic monitoring (electrocardiogram, exhaled gas analyzer, heart rate, respiratory rate and blood pressure).	8 weeks	No
Secondary	Autonomic cardiovascular control	Heart rate and blood pressure monitoring in the time domain (spectral analysis).	8 weeks	No