Inspiratory Muscle Training in Patients With Stroke in Subacute Phase.

January 8, 2019 updated by: Alicia Tovar Alcaraz, Hospital Universitario Virgen de la Arrixaca

Effects of Inspiratory Muscle Training on Lung Function, Inspiratory Muscle Strength and Trunk Balance in Patients With Stroke in Subacute Phase.

Assess the effect of inspiratory muscle training on lung function, muscle strength and trunk balance in survivors of stroke in the subacute phase of the disease

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Assess the effect of inspiratory muscle training on lung function, muscle strength and trunk balance in survivors of stroke in the subacute phase of the disease. The intervention will be done in a group of patients who will be treated in the rehabilitation service at the Virgen de la Arrixaca Hospital. They will train using a threshold IMT device or a Powerbreathe device, to increase their inspiratory muscle strength in addition to a physical therapy treatment. The intervention will last eigtht weeks and the patients will be evaluated at the beginning and at the end of the intervention.

Study Type

Interventional

Enrollment (Anticipated)

20

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 Contact

Study Contact Backup

  • Name: SILVANA L DE OLIVEIRA SOUSA, PhD
  • Phone Number: +34687184400
  • Email: soliveira@umh.es

Study Locations

  • Spain
      • Murcia, Spain, 30009
        • Recruiting
        • Alicia Tovar Alcaraz
        • Contact:
          • SILVANA L DE OLIVEIRA SOUSA, PhD
          • Phone Number: +34687184400
          • Email: soliveira@umh.es
        • Contact:
        • Principal Investigator:
          • ALICIA TOVAR ALCARAZ, Pt
        • Sub-Investigator:
          • SILVANA L DE OLIVEIRA SOUSA, PhD
        • Sub-Investigator:
          • MARTHA C LEON GARZON, PhD
        • Sub-Investigator:
          • MARIA J GONZALEZ CARRILLO, Pt

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

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Sroke 6 months before of the beginning of the study
  • Be able to understand simple commands
  • Hemiparesis or hemiplegia
  • Not have serious cardiopulmonary diseases(COPD,asthma,bronchiectasis)

Exclusion Criteria:

  • Associated neurological pathology leading to muscle weakness
  • Severe respiratory pathology, pulmonary embolism, presence of tracheostomy cannula,
  • intracranial hypertension
  • Acute retinal datachment, recent eye surgery
  • Impossibility of labial occlusion
  • Unstable heart disease, unstable angina, aortic aneurysm
  • Recent thoracic or abdominal surgery(6 months)
  • Uncontrolled arterial hypertension

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: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IMT-GE
the participants will perform a training protocol of the inspiratory muscles during 8 weeks with a load that will increase from the 15% of the maximal inspiratory preassure until the 60% of the maximal inspiratory preassure.
Device: IMT
A training protocol of the inspiratory muscles that goes from the 15% of the maximal inspiratory muscle preassure until the 60% of the maximal inspiratory muscle preassure during 8 weeks
PLACEBO_COMPARATOR: IMT-GP
The participants will perform a training protocol of the inspiratory muscles during 8 weeks with a load that will be the 10% of the maximal inspiratory preassure during all the 8 weeks
Device: IMT
A training protocol of the inspiratory muscles that goes from the 15% of the maximal inspiratory muscle preassure until the 60% of the maximal inspiratory muscle preassure during 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum inspiratory pressure
Time Frame: From the first day of evaluation and at eight weeks of the beginning of the intervention
The change of the maximum inspiratory pressure from the beginning, at 4 weeks and At 8 weeks
From the first day of evaluation and at eight weeks of the beginning of the intervention
Forzed vital capacity
Time Frame: From the first day of evaluation and at eight weeks of the beginning of the intervention
The change of the forzed vital capacity from the beginning and at the end of the intervention
From the first day of evaluation and at eight weeks of the beginning of the intervention
Forzed espiratory volume in the first second
Time Frame: From the first day of evaluation and at eight weeks of the beginning of the intervention
The change of the forzed espiratory volumen in the first second beginning and in the end of the intervention using a spirometer
From the first day of evaluation and at eight weeks of the beginning of the intervention
Voluntary maximum ventilation
Time Frame: From the first day of evaluation and at eight weeks of the beginning of the intervention
The change of the voluntary maximum ventilation from the beginning and at the end of the intervention using a spirometer
From the first day of evaluation and at eight weeks of the beginning of the intervention
The "Berg balance scale" Test
Time Frame: From the first day of evaluation and at Eight weeks of the beginning of the intervention
The change of the balance at the beginning and in the end of the intervention using the berg balance scale tool. The máximum value of this scale is 56 points, and the mínimum is 0 points. A higher value represents a better outcome.
From the first day of evaluation and at Eight weeks of the beginning of the intervention
The postural assessment scale for stroke patients (PASS )test
Time Frame: From the first day of evaluation and at Eight weeks of the beginning of the intervention
The change of the balance of the trunk at the beginning and in the end of the intervention using the postural assessment scale for stroke patinents tool. The maximum value of tris scale is 36 points. The minimum is 0 points.Higher values represents a better outcome.
From the first day of evaluation and at Eight weeks of the beginning of the intervention
Trunk control test (TCT)
Time Frame: From the first day of evaluation and at Eight weeks of the beginning of the intervention
The change of the trunk control at the beginning and in the end of the intervention. The maximum value is 100 points, and the minimum 0 points. Higher values represents a better outcome
From the first day of evaluation and at Eight weeks of the beginning of the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quadriceps dynamometry
Time Frame: From the first day of evaluation and at eight weeks of the beginning of the intervention
The change of the quadriceps´s strength with a hand held dynamometer at the beginning and in the end of the intervention. Higher values represents a better outcome
From the first day of evaluation and at eight weeks of the beginning of the intervention
"Functional ambulatory classificator" Test
Time Frame: From the first day of evaluation and at Eight weeks of the beginning of the intervention
The change of the walking capacity using the functional ambulatory classificator tool at the beginning and in the end of the intervention. The máximum value is 5 and the mínimum 0. Higher values represents a better outcome
From the first day of evaluation and at Eight weeks of the beginning of the intervention
"Functional ambulatory classificator Hospital de Sagunto" Test
Time Frame: From the first day of evaluation and at Eight weeks of the beginning of the intervention
The change of the walking capacity using the functional ambulatory classificator hospital de sagunto tool at the beginning and ni the end. The máximum value is 5 and the mínimum 0. Higher valúes represents better outcome
From the first day of evaluation and at Eight weeks of the beginning of the intervention
SF-36 health survey
Time Frame: From the first day of evaluation and at eight weeks of the beginning of the intervention
The change of the quality of life related to health with the SF-36 health survey at the beginning and in the end of the intervention
From the first day of evaluation and at eight weeks of the beginning of the intervention

Collaborators and Investigators

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

Sponsor

Hospital Universitario Virgen de la Arrixaca

Collaborators

Universidad Católica San Antonio de Murcia
Universidad Miguel Hernandez de Elche

Investigators

  • Study Director: MARTHA C LEON GARZON, PhD, UNIVERSIDAD SAN ANTONIO DE MURCIA
  • Study Director: SILVANA L DE OLIVEIRA SOUSA, PhD, Universidad Miguel Hernandez, Elche
  • Principal Investigator: ALICIA TOVAR ALCARAZ, Pt, Hospital Universitario Virgen de la Arrixaca

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 (ANTICIPATED)

January 20, 2019

Primary Completion (ANTICIPATED)

November 30, 2019

Study Completion (ANTICIPATED)

December 30, 2019

Study Registration Dates

First Submitted

December 17, 2018

First Submitted That Met QC Criteria

January 8, 2019

First Posted (ACTUAL)

January 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-10-4-HCUVA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The individual participant data includes the spirometry data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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