- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02275377
Effects of Inspiratory Muscle Training on Blood Pressure Levels in Hypertensive Individuals
May 18, 2015 updated by: Hospital de Clinicas de Porto Alegre
Effects of Inspiratory Muscle Training on Blood Pressure Levels in Hypertensive Individuals: a Randomized Clinical Trial.
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Leila B Moreira, PhD
- Phone Number: +55 51 33597695
- Email: lbmoreira@hcpa.ufrgs.br
Study Contact Backup
- Name: Simone R Posser, Msc
- Phone Number: +55 54 84096027
- Email: sposser@hcpa.ufrgs.br
Study Locations
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
- Recruiting
- Leila Moreira
-
Contact:
- Leila B Moreira, PhD
- Phone Number: +55 51 33597695
- Email: lbmoreira@hcpa.ufrgs.br
-
Contact:
- Simone R Posser, Msc
- Phone Number: +55 54 84096027
- Email: sposser@hcpa.ufrgs.br
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
33 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
Other Names:
|
Placebo Comparator: Sham IMT
Participants will be submitted to inspiratory muscle training with the same equipment as the intervention group, but without a load generating resistance.
|
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.
Other Names:
|
No Intervention: Normotensive
The normotensive control group (healthy) will go through the same initial evaluation without performing inspiratory muscle training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Levels of blood pressure (mmHg)
Time Frame: 8 weeks
|
Ambulatory blood pressure monitoring (ABPM).
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inspiratory muscle mechanoreflex
Time Frame: 8 weeks
|
Venous occlusion plethysmography measure during inspiratory muscle training exercise at 60% and 2% of maximal inspiratory muscle strength.
|
8 weeks
|
Cardiopulmonary Capacity
Time Frame: 8 weeks
|
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
|
Autonomic cardiovascular control
Time Frame: 8 weeks
|
Heart rate and blood pressure monitoring in the time domain (spectral analysis).
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Leila B Moreira, PhD, Hospital de Clinicas de Porto Alegre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Anticipated)
October 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
September 30, 2014
First Submitted That Met QC Criteria
October 23, 2014
First Posted (Estimate)
October 27, 2014
Study Record Updates
Last Update Posted (Estimate)
May 19, 2015
Last Update Submitted That Met QC Criteria
May 18, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-0405
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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