Clinical trial NCT02416349: Acute Effects After Stretching Respiratory Muscles on Ventilatory Pattern and Volume Distribution of Chest Wall
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Stretching
Respiratory muscle
Ventilatory pattern
Optoelectronic plethysmography
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2015-04-15
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Chest Wall Volume
timeFrame: During assessment and intervention, on average for an hour
measure: Compartmental chest wall volumes (composite)
timeFrame: During assessment and intervention, on average for an hour
Secondary outcomes:
measure: Ventilatory Pattern (Composite)
timeFrame: During assessment and intervention, on average for an hour
measure: Lung Capacity (Composite)
timeFrame: During assessment and intervention, on average for an hour
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Universidade Federal de Pernambuco - Laboratório de Fisiologia e Fisioterapia Cardiopulmonar - Recife - Brasil
state: Pernambuco
Study officials:
affiliation: Federal University of Pernambuco - Department of Physical Therapy
name: Armele Andrade, PhD
role: STUDY_DIRECTOR
References:
citation: Rattes C, Campos SL, Morais C, Goncalves T, Sayao LB, Galindo-Filho VC, Parreira V, Aliverti A, Dornelas de Andrade A. Respiratory muscles stretching acutely increases expansion in hemiparetic chest wall. Respir Physiol Neurobiol. 2018 Aug;254:16-22. doi: 10.1016/j.resp.2018.03.015. Epub 2018 Mar 30.