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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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)

Eligibility Criteria

• 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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Contacts and Locations

Contacts

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

Locations

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

• Study Director: Armele Dornelas, PhD; Federal University of Pernambuco Physiotherapy Department

More Information

• 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
• 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:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases