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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02088125
• Other study ID #: Stroke
• Status: Recruiting
• Phase: N/A
• First received: February 24, 2014
• Last updated: March 12, 2014
• Start date: September 2013
• Est. completion date: August 2014

Study information

• Verified date: March 2014
• Source: Universidade Federal de Pernambuco
• Contact: Catarina Rattes
• Phone: +55 81 21268496
• Email: catarina_rattes[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ministry of HealthBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: August 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Department of Physical Therapy, Federal University of Pernambuco, Recife, Pernambuco, Brazil	Recife	Pernambuco

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of the chest wall and Thoraco-abdominal compartments (pulmonary rib cage, abdominal rib cage and abdomen)	Total chest wall and in the Differents thoraco-abdominal compartments measured by Opto-electronic plethysmography (OEP)	During assessment and intervention, on average for an hour	No
Secondary	Ventilatory Pattern (minute ventilation, breathing frequency, inspiratory time (TI), expiratory time (TE), duty cycle (TI/TTOT), tidal volume, mean inspiratory flow, mean expiratory flow)	From variations of Volume of the chest wall during breathing measured by Opto-electronic plethysmography (OEP)	During assessment and intervention, on average for an hour	No