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Status unknownNCT02275377Updated May 19, 2015

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

An interventional study of Inspiratory muscle training (IMT) and Sham IMT in Hypertension, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 1 site in Brazil. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-19.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable and Interventional

The sponsor has not verified this record recently (last verified May 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
35 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Hypertension

Keywords

  • Breathing Exercises; Autonomic Control; Blood Pressure.
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In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's planned enrollment of 60 is above the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • 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.

    Other: Inspiratory muscle training (IMT)

  • 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.

    Other: Sham IMT

  • No intervention
    Normotensive

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

Interventions

  • OtherInspiratory 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.

    Also known as: Inspiratory muscle training

  • OtherSham 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.

    Also known as: Sham Inspiratory muscle training

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What researchers measure

Primary outcomes

  1. Levels of blood pressure (mmHg)

    Ambulatory blood pressure monitoring (ABPM).

    Time frame: 8 weeks

Secondary outcomes

  1. Inspiratory muscle mechanoreflex

    Venous occlusion plethysmography measure during inspiratory muscle training exercise at 60% and 2% of maximal inspiratory muscle strength.

    Time frame: 8 weeks

  2. 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).

    Time frame: 8 weeks

  3. Autonomic cardiovascular control

    Heart rate and blood pressure monitoring in the time domain (spectral analysis).

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
  • Leila Moreira
    Porto Alegre, Rio Grande do Sul 90035-903, Brazil
    Recruiting
08

References and documents

Publications

  • 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. PubMed 27484507 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02275377
Lead sponsor
Hospital de Clinicas de Porto Alegre
Responsible party
Sponsor
First posted
Oct 27, 2014
Start date
Oct 2014
Primary completion
Oct 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
May 19, 2015

Study contacts

Leila B Moreira, PhD
Contact
lbmoreira@hcpa.ufrgs.br
+55 51 33597695
Simone R Posser, MsC
Contact
sposser@hcpa.ufrgs.br
+55 54 84096027
Leila B Moreira, PhD
principal investigator · Hospital de Clinicas de Porto Alegre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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