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Influence of Respiratory Muscle Training in Elderly Hypertensive Women With Respiratory Muscle Weakness

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Threshold
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring hypertension

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of hypertension controlled by antihypertensive;
  • aged between 60 and 80 years;
  • absence of dementia or cognitive impairments that limit tests;
  • absence of recent myocardial infarction;
  • absence of musculoskeletal limitations that limit tests;
  • availability of time on training days.

Exclusion Criteria:

  • clinical instability;
  • inability to perform any test.

Sites / Locations

  • Universidade Federal do Rio Grande do Norte

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

threshold

Arm Description

Held inspiratory muscle strengthening for 5 weeks with Threshold, charging 30% of maximal inspiratory pressure, 7 days a week, one supervised and unsupervised 6.

Outcomes

Primary Outcome Measures

manovacuometry
Evaluates indirectly respiratory muscle strength.

Secondary Outcome Measures

spirometry
Assesses lung function

Full Information

First Posted
November 12, 2012
Last Updated
December 4, 2012
Sponsor
Universidade Federal do Rio Grande do Norte
Collaborators
Foundation for research support from the state of Rio Grande do Norte (FAPERN)
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1. Study Identification

Unique Protocol Identification Number
NCT01743183
Brief Title
Influence of Respiratory Muscle Training in Elderly Hypertensive Women With Respiratory Muscle Weakness
Official Title
Influence of Respiratory Muscle Training in Elderly Hypertensive Women With Respiratory Muscle Weakness
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte
Collaborators
Foundation for research support from the state of Rio Grande do Norte (FAPERN)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to evaluate pulmonary function and respiratory muscle strength in a group of elderly women with hypertension before and after a respiratory muscle training.
Detailed Description
It is a respiratory muscle training using the Threshold for 5 weeks, with a load of 30% of maximal inspiratory pressure obtained in manometer for 30 minutes daily. Furthermore, the assessment includes: test 6-minute walk, the quality of life questionnaire, MINICHAL, the IPAQ short version, manometer and spirometry.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
threshold
Arm Type
Experimental
Arm Description
Held inspiratory muscle strengthening for 5 weeks with Threshold, charging 30% of maximal inspiratory pressure, 7 days a week, one supervised and unsupervised 6.
Intervention Type
Device
Intervention Name(s)
Threshold
Intervention Description
The load adjustment was done weekly by a single examiner.
Primary Outcome Measure Information:
Title
manovacuometry
Description
Evaluates indirectly respiratory muscle strength.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
spirometry
Description
Assesses lung function
Other Pre-specified Outcome Measures:
Title
quality of life
Description
Assesses the influence of hypertension on the quality of life of target
Title
functional capacity
Description
assesses the cardiopulmonary capacity at sub-maximal
Title
IPAQ
Description
assesses the level of physical activity

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of hypertension controlled by antihypertensive; aged between 60 and 80 years; absence of dementia or cognitive impairments that limit tests; absence of recent myocardial infarction; absence of musculoskeletal limitations that limit tests; availability of time on training days. Exclusion Criteria: clinical instability; inability to perform any test.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrícia Nogueira
Organizational Affiliation
Universidade Federal do Rio Grande do Norte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal do Rio Grande do Norte
City
Natal
State/Province
Rio Grande do Norte
Country
Brazil

12. IPD Sharing Statement

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Influence of Respiratory Muscle Training in Elderly Hypertensive Women With Respiratory Muscle Weakness

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