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

April 9, 2015 updated by: Catarina Souza Ferreira Rattes Lima, Universidade Federal de Pernambuco

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50740 - 560
        • Universidade Federal de Pernambuco - Laboratório de Fisiologia e Fisioterapia Cardiopulmonar - Recife - Brasil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Respiratory Muscles Stretching
Respiratory Muscles Stretching Neck stretching, upper chest stretching, pectoralis major stretching and lateral chest stretching.
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
Placebo Comparator: Control Group
All volunteers will be positioned at rest in a comfortable in a chair during 20 minutes.
Other: Control Group
Control Group - all volunteers will be positioned at rest in a comfortable in a chair during 20 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chest Wall Volume
Time Frame: During assessment and intervention, on average for an hour
Vcw -Total chest wall volume by Optoelectronic Plethysmography.
During assessment and intervention, on average for an hour
Compartmental chest wall volumes (composite)
Time Frame: During assessment and intervention, on average for an hour
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilatory Pattern (Composite)
Time Frame: During assessment and intervention, on average for an hour
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
Lung Capacity (Composite)
Time Frame: During assessment and intervention, on average for an hour
VC - Vital capacity; Inspiratory Capacity by Optoelectronic Plethysmography.
During assessment and intervention, on average for an hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Pernambuco

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Study Director: Armele Andrade, PhD, Federal University of Pernambuco - Department of Physical Therapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

March 14, 2014

First Submitted That Met QC Criteria

April 9, 2015

First Posted (Estimate)

April 15, 2015

Study Record Updates

Last Update Posted (Estimate)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STRETCHING RESPIRATORY MUSCLES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Respiratory Muscles Stretching

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe