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

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ClinicalTrials.gov Identifier: NCT02088125
Recruitment Status : Unknown
Verified March 2014 by Catarina Souza Ferreira Rattes Lima, Universidade Federal de Pernambuco.
Recruitment status was:  Recruiting
First Posted : March 14, 2014
Last Update Posted : March 14, 2014
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Catarina Souza Ferreira Rattes Lima, Universidade Federal de Pernambuco

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 .

Condition or disease Intervention/treatment Phase
Stroke Other: Breath Stacking Other: Incentive Spirometry Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Dynamic Ventilatory and Asymmetry of the Chest Wall During Breath Stacking and Volume-oriented Incentive Spirometer in Patients After Stroke: Crossover Clinical Trial
Study Start Date : September 2013
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : August 2014

Arm Intervention/treatment
Active Comparator: 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.
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.

Active Comparator: 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.
Other: 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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Ventilatory Pattern (minute ventilation, breathing frequency, inspiratory time (TI), expiratory time (TE), duty cycle (TI/TTOT), tidal volume, mean inspiratory flow, mean expiratory flow) [ Time Frame: During assessment and intervention, on average for an hour ]
    From variations of Volume of the chest wall during breathing measured by Opto-electronic plethysmography (OEP)



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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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.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088125


Contacts
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Contact: Catarina Rattes +55 81 21268496 catarina_rattes@hotmail.com

Locations
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Brazil
Department of Physical Therapy, Federal University of Pernambuco, Recife, Pernambuco, Brazil Recruiting
Recife, Pernambuco, Brazil, 50670-901
Contact: Armele Andrade, PhD    +55 81 21268496    armeledornelas@hotmail.com   
Principal Investigator: Catarina Rattes         
Sponsors and Collaborators
Universidade Federal de Pernambuco
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Study Director: Armele Dornelas, PhD Federal University of Pernambuco Physiotherapy Department
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Responsible Party: 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
ClinicalTrials.gov Identifier: NCT02088125    
Other Study ID Numbers: Stroke
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: March 14, 2014
Last Verified: March 2014
Keywords provided by Catarina Souza Ferreira Rattes Lima, Universidade Federal de Pernambuco:
Stroke
Incentive Spirometry
Breath Stacking
Optoelectronic Plethysmography
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases