Influence of Respiratory Muscle Training in Elderly Hyper... | NCT01743183

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

NCT01743183

Sponsor

Universidade Federal do Rio Grande do Norte

Status

Completed

Last Update Posted

Dec 6, 2012Estimated

Enrollment

4Actual

Phase

Not Applicable

Conditions

Hypertension

Interventions

Threshold

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Oct 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Nov 12, 2012

First Submission Date that Met QC Criteria

Dec 4, 2012

First Posted Date

Dec 6, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2012

Last Update Posted Date

Dec 6, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Patra-cia Angelica de Miranda Silva Nogueira, Patrícia Angélica de Miranda Silva Nogueira, Universidade Federal do Rio Grande do NortePrincipal Investigator

Lead Sponsor

Universidade Federal do Rio Grande do NorteOTHER

Collaborators

Name	Class
Foundation for research support from the state of Rio Grande do Norte (FAPERN)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
threshold	Experimental	Held inspiratory muscle strengthening for 5 weeks with Threshold, charging 30% of maximal inspiratory pressure, 7 days a week, one supervised and unsupervised 6.	Device: Threshold

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Threshold	Device	The load adjustment was done weekly by a single examiner.	threshold

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
manovacuometry	Evaluates indirectly respiratory muscle strength.	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
spirometry	Assesses lung function

Other Outcomes

Measure	Description	Time Frame
quality of life	Assesses the influence of hypertension on the quality of life of target
functional capacity	assesses the cardiopulmonary capacity at sub-maximal

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrícia Nogueira	Universidade Federal do Rio Grande do Norte	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidade Federal do Rio Grande do Norte		Natal	Rio Grande do Norte		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013069	Speech Reception Threshold Test

Ancestor Terms

ID	Term
D001302	Audiometry, Speech
D001299	Audiometry
D006320	Hearing Tests
D003939	Diagnostic Techniques, Otological

Browse Leaves

Not provided

Browse Branches

Not provided