NCT01250444

Brief Summary

The purpose of this study is to determine inspiratory muscle training effects on blood pressure, functional capacity and quality of life in hypertensive patients.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2010

Completed
Last Updated

November 30, 2010

Status Verified

October 1, 2010

Enrollment Period

1.3 years

First QC Date

November 29, 2010

Last Update Submit

November 29, 2010

Conditions

Reduction of Blood Pressure in Hypertensive Patients.Improvement of Cardiovascular Autonomic Control.Improvement of Functional Capacity.Improvement of Quality of Life.

Keywords

Inspiratory Muscle TrainingHypertensionBreathing ExercisesCardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Differences on blood pressure levels

    Blood pressure behavior is accessed by Ambulatory Blood Pressure Monitorying.

    eight weeks

Secondary Outcomes (3)

  • improvement of Heart rate variability

    eight weeks

  • improvement of quality of life

    eigth weeks

  • Improvement of Functional Capacity

    eight weeks

Study Arms (1)

Inspiratory Muscle Training

EXPERIMENTAL

It will me performed a loaded training of ventilatory muscles in patients with Hypertension. Its is done with the practice of breathing exercises associated to an training device, specific for this kind of intervention.

Other: Inspiratory Muscle Training

Interventions

Inspiratory Muscle TrainingOTHER

Breathing exercises associated to the use of a training device with predetermined pressure load, daily, 30 minutes per day, during eight weeks.

Inspiratory Muscle Training

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 25 and 70
  • Hypertension in all stages:
  • Prehypertension - Systolic blood pressure (SBP) of 120 to 139 and/or diastolic blood pressure (DBP) of 80 to 89 mmHg 2.2.Stage 1 Hypertension - SBP of 140 to 159 mmHg and/or DBP of 90 to 99 mmHg 2.3.Stage 2 Hypertension - SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg

You may not qualify if:

  • Disagreement with consent form
  • Thoracic pain (angina)
  • Hypertension instability
  • Antihypertensive drugs alterations within 30 days before or during the study
  • Diabetes
  • Chronic pulmonary obstructive disease
  • Incapability of executing the functional tests
  • Asthma
  • Chronic Heart Failure
  • Obesity
  • Cardiovascular diseases complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pedro Dal Lago

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 29, 2010

First Posted

November 30, 2010

Study Start

March 1, 2009

Primary Completion

July 1, 2010

Last Updated

November 30, 2010

Record last verified: 2010-10

Locations

BR(1)