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

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Respiratory Muscles Stretching

Control Group

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Stretching, Respiratory muscle, Ventilatory pattern, Optoelectronic plethysmography

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Universidade Federal de Pernambuco - Laboratório de Fisiologia e Fisioterapia Cardiopulmonar - Recife - Brasil

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Respiratory Muscles Stretching

Control Group

Arm Description

Respiratory Muscles Stretching Neck stretching, upper chest stretching, pectoralis major stretching and lateral chest stretching.

All volunteers will be positioned at rest in a comfortable in a chair during 20 minutes.

Outcomes

Primary Outcome Measures

Chest Wall Volume

Vcw -Total chest wall volume by Optoelectronic Plethysmography.

Compartmental chest wall volumes (composite)

Vrcp - rib cage pulmonary volume; Vrca - rib cage abdominal volume; Vab - abdominal volume by Optoelectronic Plethysmography.

Secondary Outcome Measures

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)

Lung Capacity (Composite)

VC - Vital capacity; Inspiratory Capacity by Optoelectronic Plethysmography.

Full Information

NCT ID

NCT02416349

First Posted

March 14, 2014

Last Updated

April 9, 2015

Sponsor

Universidade Federal de Pernambuco

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

1. Study Identification

Unique Protocol Identification Number

NCT02416349

Brief Title

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

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade Federal de Pernambuco

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Stroke, Stretching, Respiratory muscle, Ventilatory pattern, Optoelectronic plethysmography

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Respiratory Muscles Stretching

Arm Type

Active Comparator

Arm Description

Respiratory Muscles Stretching Neck stretching, upper chest stretching, pectoralis major stretching and lateral chest stretching.

Arm Title

Control Group

Arm Type

Placebo Comparator

Arm Description

All volunteers will be positioned at rest in a comfortable in a chair during 20 minutes.

Intervention Type

Other

Intervention Name(s)

Respiratory Muscles Stretching

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Control Group

Intervention Description

Control Group - all volunteers will be positioned at rest in a comfortable in a chair during 20 minutes.

Primary Outcome Measure Information:

Title

Chest Wall Volume

Description

Vcw -Total chest wall volume by Optoelectronic Plethysmography.

Time Frame

During assessment and intervention, on average for an hour

Title

Compartmental chest wall volumes (composite)

Description

Vrcp - rib cage pulmonary volume; Vrca - rib cage abdominal volume; Vab - abdominal volume by Optoelectronic Plethysmography.

Time Frame

During assessment and intervention, on average for an hour

Secondary Outcome Measure Information:

Title

Ventilatory Pattern (Composite)

Description

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)

Time Frame

During assessment and intervention, on average for an hour

Title

Lung Capacity (Composite)

Description

VC - Vital capacity; Inspiratory Capacity by Optoelectronic Plethysmography.

Time Frame

During assessment and intervention, on average for an hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Armele Andrade, PhD

Organizational Affiliation

Federal University of Pernambuco - Department of Physical Therapy

Official's Role

Study Director

Facility Information:

Facility Name

Universidade Federal de Pernambuco - Laboratório de Fisiologia e Fisioterapia Cardiopulmonar - Recife - Brasil

City

Recife

State/Province

Pernambuco

ZIP/Postal Code

50740 - 560

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

29608976

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.

Results Reference

derived

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

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