NCT01743183

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2012

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
Last Updated

December 6, 2012

Status Verified

December 1, 2012

Enrollment Period

1 month

First QC Date

November 12, 2012

Last Update Submit

December 4, 2012

Conditions

Hypertension

Keywords

hypertension

Outcome Measures

Primary Outcomes (1)

  • manovacuometry

    Evaluates indirectly respiratory muscle strength.

    6 weeks

Secondary Outcomes (1)

  • spirometry

Other Outcomes (3)

  • quality of life

  • functional capacity

  • IPAQ

Study Arms (1)

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

ThresholdDEVICE

The load adjustment was done weekly by a single examiner.

threshold

Eligibility Criteria

Age60 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • clinical instability;
  • inability to perform any test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Rio Grande do Norte

Natal, Rio Grande do Norte, Brazil

Location

MeSH Terms

Conditions

Hypertension

Interventions

Speech Reception Threshold Test

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Audiometry, SpeechAudiometryHearing TestsDiagnostic Techniques, OtologicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Patrícia Nogueira

    Universidade Federal do Rio Grande do Norte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Patrícia Angélica de Miranda Silva Nogueira

Study Record Dates

First Submitted

November 12, 2012

First Posted

December 6, 2012

Study Start

September 1, 2012

Primary Completion

October 1, 2012

Study Completion

November 1, 2012

Last Updated

December 6, 2012

Record last verified: 2012-12

Locations

BR(1)