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Clinical Trials/NCT02088125
NCT02088125UnknownNot Applicable

Dynamic Ventilatory and Asymmetry of the Chest Wall During Breath Stacking and Volume-oriented Incentive Spirometer in Patients After Stroke: Crossover Clinical Trial

Universidade Federal de Pernambuco1 site in 1 country12 target enrollmentStarted: September 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
12
Locations
1
Primary Endpoint
Volume of the chest wall and Thoraco-abdominal compartments (pulmonary rib cage, abdominal rib cage and abdomen)

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Subjects with right hemiparesis due to stroke for more than three months, of both genders, most than 20 years, with scores between 1 and 3 for Ashworth Scale for upper limb, up to 85 for Index score Barthel and minimum score of 18 on the Mini Mental State Examination.

Exclusion Criteria

  • •Facial paralysis, rheumatic or orthopedic diseases or deformities / abnormalities in the spine that could compromise the respiratory mechanics; reported respiratory conditions (asthma, chronic obstructive pulmonary disease, cystic fibrosis) or presenting spirometry with forced expiratory volume in one second (FEV1) below 80% predicted and compared VEF1/Capacitate Forced vital ≤ .7; history of recent abdominal or thoracic surgery and hemodynamic instability or pregnancy.

Arms & Interventions

Incentive Spirometry

Active Comparator

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: Incentive Spirometry (Other)

Breath Stacking

Active Comparator

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: Breath Stacking (Other)

Outcomes

Primary Outcomes

Volume of the chest wall and Thoraco-abdominal compartments (pulmonary rib cage, abdominal rib cage and abdomen)

Time Frame: During assessment and intervention, on average for an hour

Total chest wall and in the Differents thoraco-abdominal compartments measured by Opto-electronic plethysmography (OEP)

Secondary Outcomes

  • Ventilatory Pattern (minute ventilation, breathing frequency, inspiratory time (TI), expiratory time (TE), duty cycle (TI/TTOT), tidal volume, mean inspiratory flow, mean expiratory flow)(During assessment and intervention, on average for an hour)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

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

Universidade Federal de Pernambuco

Study Sites (1)

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