Dynamic Ventilatory and Asymmetry of the Chest Wall During Breath Stacking and Volume-oriented Incentive Spirometer
1 other identifier
interventional
12
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Sep 2013
Shorter than P25 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 24, 2014
CompletedFirst Posted
Study publicly available on registry
March 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedMarch 14, 2014
March 1, 2014
10 months
February 24, 2014
March 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (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)
During assessment and intervention, on average for an hour
Study Arms (2)
Incentive Spirometry
ACTIVE COMPARATORThe 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
ACTIVE COMPARATORBreath 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
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.
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Physical Therapy, Federal University of Pernambuco, Recife, Pernambuco, Brazil
Recife, Pernambuco, 50670-901, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Armele Dornelas, PhD
Federal University of Pernambuco Physiotherapy Department
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI 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 Record Dates
First Submitted
February 24, 2014
First Posted
March 14, 2014
Study Start
September 1, 2013
Primary Completion
July 1, 2014
Study Completion
August 1, 2014
Last Updated
March 14, 2014
Record last verified: 2014-03