Dynamic Ventilatory and Asymmetry of the Chest Wall During Breath Stacking and Volume-oriented Incentive Spirometer

NCT ID: NCT02088125

Last Updated: 2014-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-08-31

Brief Summary

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The purpose of the study was to analyze the effect of IS and BS on dynamics ventilatory and asymmetry of the chest wall in patients after stroke .

Detailed Description

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All volunteers were undergone to two types of pulmonary expansion therapy (PET) techniques: volume incentive spirometry (VIS) and BS.

Procedures involved two distinct phases: assessment and intervention. In the first day was performed assessment of the participants to obtain the following data: anamnesis, initial evaluation using the Ashwouth Scale, Barthel Index and Mini Mental State Examination, anthropometric data and pulmonary function using spirometry and respiratory muscle pressures.

Intervention phase was performed in two different days, each day for only one PET techniques (VIS or BS), with a minimal wash-out period of one day according to the randomization sequence. Optoelectronic Pletysmography (OEP) was recorded during quite breathing at rest and during the execution of five maneuvers form each PET technique tested.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Incentive Spirometry

The Incentive Spirometry was characterized by the use of the incentive spirometer volume, in which volunteer used a nasal clip and was instructed to inhale slowly and deeply through the mouthpiece of the equipment from functional residual capacity to total lung capacity.

Group Type ACTIVE_COMPARATOR

Incentive Spirometry

Intervention Type OTHER

The Incentive Spirometry was characterized by the use of the incentive spirometer volume, in which volunteer used a nasal clip and was instructed to inhale slowly and deeply through the mouthpiece of the equipment from functional residual capacity to total lung capacity.

Breath Stacking

Breath Stacking A mask was used with two one-way valves (inspiratory limb and expiratory limb), which was coupled to the patient's face allowing only inspiration, while the expiratory branch remained occluded for the individual only perform successive inspiratory efforts.

Group Type ACTIVE_COMPARATOR

Breath Stacking

Intervention Type OTHER

Breath Stacking A mask was used with two one-way valves (inspiratory limb and expiratory limb), which was coupled to the patient's face allowing only inspiration, while the expiratory branch remained occluded for the individual only perform successive inspiratory efforts.

Interventions

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Breath Stacking

Breath Stacking A mask was used with two one-way valves (inspiratory limb and expiratory limb), which was coupled to the patient's face allowing only inspiration, while the expiratory branch remained occluded for the individual only perform successive inspiratory efforts.

Intervention Type OTHER

Incentive Spirometry

The Incentive Spirometry was characterized by the use of the incentive spirometer volume, in which volunteer used a nasal clip and was instructed to inhale slowly and deeply through the mouthpiece of the equipment from functional residual capacity to total lung capacity.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Universidade Federal de Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Catarina Souza Ferreira Rattes Lima

Dynamic ventilatory and asymmetry of the chest wall during breath stacking and volume-oriented incentive spirometer in patients after stroke: crossover clinical trial

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Armele Dornelas, PhD

Role: STUDY_DIRECTOR

Federal University of Pernambuco Physiotherapy Department

Locations

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Department of Physical Therapy, Federal University of Pernambuco, Recife, Pernambuco, Brazil

Recife, Pernambuco, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Catarina Rattes

Role: CONTACT

+55 81 21268496

Facility Contacts

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Armele Andrade, PhD

Role: primary

+55 81 21268496

Other Identifiers

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Stroke

Identifier Type: -

Identifier Source: org_study_id

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