Effects of Inspiratory Muscle Training on Blood Pressure Levels in Hypertensive Individuals
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hypertension
Started Oct 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
October 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMay 19, 2015
May 1, 2015
1 year
September 30, 2014
May 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Levels of blood pressure (mmHg)
Ambulatory blood pressure monitoring (ABPM).
8 weeks
Secondary Outcomes (3)
Inspiratory muscle mechanoreflex
8 weeks
Cardiopulmonary Capacity
8 weeks
Autonomic cardiovascular control
8 weeks
Study Arms (3)
Inspiratory muscle training (IMT)
EXPERIMENTALParticipants 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.
Sham IMT
PLACEBO COMPARATORParticipants will be submitted to inspiratory muscle training with the same equipment as the intervention group, but without a load generating resistance.
Normotensive
NO INTERVENTIONThe normotensive control group (healthy) will go through the same initial evaluation without performing inspiratory muscle training.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Leila Moreira
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Related Publications (1)
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.
PMID: 27484507DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leila B Moreira, PhD
Hospital de Clinicas de Porto Alegre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2014
First Posted
October 27, 2014
Study Start
October 1, 2014
Primary Completion
October 1, 2015
Study Completion
December 1, 2015
Last Updated
May 19, 2015
Record last verified: 2015-05