Acute Effects After Stretching Respiratory Muscles on Ventilatory Pattern and Volume Distribution of Chest Wall

Stroke Clinical Trial

Official title:

Acute Effects After Stretching Respiratory Muscles on Ventilatory Pattern and Volume Distribution of Chest Wall in Patients With Stroke: a Randomized Crossover Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02416349
• Other study ID #: STRETCHING RESPIRATORY MUSCLES
• Status: Completed
• Phase: N/A
• First received: March 14, 2014
• Last updated: April 9, 2015
• Start date: November 2013
• Est. completion date: April 2015

Study information

• Verified date: March 2014
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The purpose of study is to evaluate the acute effects of respiratory muscles stretching on ventilator pattern and volume distribution of chest wall in patients with right hemiparesis post-stroke and our hypothesis is that the use of RMS will be able to improve changes in the respiratory function.

Description:

All study protocol will be performing in three different days. In the first day, the participants will undergo to the initial assessment, which consisted of anamnesis and anthropometric measurements: weight, height and body mass index (BMI). Then, they will be submitting to spirometry and respiratory muscle pressure using a manovacuometer.

All patients will submit underwent two types of intervention: respiratory muscles stretching (RMS) and remain at rest (control group). The stretching will occur throughout the expiratory phase to allow respiratory muscles to reach their maximal length, and two sets with 10 consecutive incursions will use for each stretching pattern with an interval of 30 seconds between series.

For the intervention in the control group, all volunteers will be position at rest in a comfortable in a chair during 20 minutes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients post-stroke with right hemiparesis no more than 3 months, from both sexes, aged above 20 years, score between 1 and 3 according to Ashworth Scale for upper limbs, score above 85 according to Barthel Index and a minimum punctuation of 18 for Mini Mental State Examination.

Exclusion Criteria:

• Volunteers presenting facial paralysis; rheumatic or orthopedic diseases; spinal abnormalities or deformities that compromise the respiratory mechanics; spirometry with forced expired volume in the first second (FEV1) bellow 80% from predicted values and FEV1/forced vital capacity (FVC) = .7; presenting respiratory comorbidities; recent history of thoracic or abdominal surgery; hemodynamic instability or pregnancy.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Respiratory Muscles Stretching
Respiratory Muscles Stretching The stretching will occur throughout the expiratory phase to allow respiratory muscles to reach their maximal length, and two sets with 10 consecutive incursions will be use for each stretching pattern with an interval of 30 seconds between series. Pattern 1: Neck stretching Pattern 2: Upper chest stretching Pattern 3:Pectoralis major stretching Pattern 4:Lateral chest stretching
• Control Group
Control Group - all volunteers will be positioned at rest in a comfortable in a chair during 20 minutes.

Locations

Country	Name	City	State
Brazil	Universidade Federal de Pernambuco - Laboratório de Fisiologia e Fisioterapia Cardiopulmonar - Recife - Brasil	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	Chest Wall Volume	Vcw -Total chest wall volume by Optoelectronic Plethysmography.	During assessment and intervention, on average for an hour	No
Primary	Compartmental chest wall volumes (composite)	Vrcp - rib cage pulmonary volume; Vrca - rib cage abdominal volume; Vab - abdominal volume by Optoelectronic Plethysmography.	During assessment and intervention, on average for an hour	No
Secondary	Ventilatory Pattern (Composite)	Total time (Ttot), inspiratory time (Tinsp), expiratory time (Texp), Tinsp/Ttot index, breathing rate (BR), minute volume (VE), mean inspiratory flow (MIF) and mean expiratory flow (MEF)	During assessment and intervention, on average for an hour	No
Secondary	Lung Capacity (Composite)	VC - Vital capacity; Inspiratory Capacity by Optoelectronic Plethysmography.	During assessment and intervention, on average for an hour	No