NCT02416349

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
Last Updated

April 15, 2015

Status Verified

March 1, 2014

Enrollment Period

1.3 years

First QC Date

March 14, 2014

Last Update Submit

April 9, 2015

Conditions

Stroke

Keywords

StrokeStretchingRespiratory muscleVentilatory patternOptoelectronic plethysmography

Outcome Measures

Primary Outcomes (2)

  • Chest Wall Volume

    Vcw -Total chest wall volume by Optoelectronic Plethysmography.

    During assessment and intervention, on average for an hour

  • 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

Secondary Outcomes (2)

  • Ventilatory Pattern (Composite)

    During assessment and intervention, on average for an hour

  • Lung Capacity (Composite)

    During assessment and intervention, on average for an hour

Study Arms (2)

Respiratory Muscles Stretching

ACTIVE COMPARATOR

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

Other: Respiratory Muscles Stretching

Control Group

PLACEBO COMPARATOR

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

Other: Control Group

Interventions

Respiratory Muscles StretchingOTHER

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

Respiratory Muscles Stretching
Control GroupOTHER

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

Control Group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Recife, Pernambuco, 50740 - 560, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 29608976DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Armele Andrade, PhD

    Federal University of Pernambuco - Department of Physical Therapy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc

Study Record Dates

First Submitted

March 14, 2014

First Posted

April 15, 2015

Study Start

November 1, 2013

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

April 15, 2015

Record last verified: 2014-03

Locations

BR(1)