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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01743183
Other study ID # 05135912.8.0000.5537
Secondary ID
Status Completed
Phase N/A
First received November 12, 2012
Last updated December 4, 2012
Start date September 2012
Est. completion date November 2012

Study information

Verified date December 2012
Source Universidade Federal do Rio Grande do Norte
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date November 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Female
Age group 60 Years to 80 Years
Eligibility 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Threshold
The load adjustment was done weekly by a single examiner.

Locations

Country Name City State
Brazil Universidade Federal do Rio Grande do Norte Natal Rio Grande do Norte

Sponsors (2)

Lead Sponsor Collaborator
Universidade Federal do Rio Grande do Norte Foundation for research support from the state of Rio Grande do Norte (FAPERN)

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Other quality of life Assesses the influence of hypertension on the quality of life of target No
Other functional capacity assesses the cardiopulmonary capacity at sub-maximal No
Other IPAQ assesses the level of physical activity No
Primary manovacuometry Evaluates indirectly respiratory muscle strength. 6 weeks No
Secondary spirometry Assesses lung function No
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