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Inspiratory Muscle Training in Patients With Stroke in Subacute Phase.

Primary Purpose

Stroke Rehabilitation

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
IMT
Sponsored by
Hospital Universitario Virgen de la Arrixaca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Rehabilitation focused on measuring stroke, respiratory muscles, lung, stroke rehabilitation

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alicia Tovar AlcarazRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IMT-GE

IMT-GP

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Maximum inspiratory pressure
The change of the maximum inspiratory pressure from the beginning, at 4 weeks and At 8 weeks
Forzed vital capacity
The change of the forzed vital capacity from the beginning and at the end of the intervention
Forzed espiratory volume in the first second
The change of the forzed espiratory volumen in the first second beginning and in the end of the intervention using a spirometer
Voluntary maximum ventilation
The change of the voluntary maximum ventilation from the beginning and at the end of the intervention using a spirometer
The "Berg balance scale" Test
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.
The postural assessment scale for stroke patients (PASS )test
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.
Trunk control test (TCT)
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

Secondary Outcome Measures

Quadriceps dynamometry
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
"Functional ambulatory classificator" Test
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
"Functional ambulatory classificator Hospital de Sagunto" Test
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
SF-36 health survey
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

Full Information

First Posted
December 17, 2018
Last Updated
January 8, 2019
Sponsor
Hospital Universitario Virgen de la Arrixaca
Collaborators
Universidad Católica San Antonio de Murcia, Universidad Miguel Hernandez de Elche
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1. Study Identification

Unique Protocol Identification Number
NCT03800485
Brief Title
Inspiratory Muscle Training in Patients With Stroke in Subacute Phase.
Official Title
Effects of Inspiratory Muscle Training on Lung Function, Inspiratory Muscle Strength and Trunk Balance in Patients With Stroke in Subacute Phase.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2019 (Anticipated)
Primary Completion Date
November 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Virgen de la Arrixaca
Collaborators
Universidad Católica San Antonio de Murcia, Universidad Miguel Hernandez de Elche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Rehabilitation
Keywords
stroke, respiratory muscles, lung, stroke rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are two groups, the intervention group and the placebo group.
Masking
ParticipantCare ProviderInvestigator
Masking Description
The study is blinded so neither the patient, neither the psysical therapist nor the investigator knows in which group the patient is
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IMT-GE
Arm Type
Experimental
Arm Description
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.
Arm Title
IMT-GP
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
IMT
Intervention Description
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
Primary Outcome Measure Information:
Title
Maximum inspiratory pressure
Description
The change of the maximum inspiratory pressure from the beginning, at 4 weeks and At 8 weeks
Time Frame
From the first day of evaluation and at eight weeks of the beginning of the intervention
Title
Forzed vital capacity
Description
The change of the forzed vital capacity from the beginning and at the end of the intervention
Time Frame
From the first day of evaluation and at eight weeks of the beginning of the intervention
Title
Forzed espiratory volume in the first second
Description
The change of the forzed espiratory volumen in the first second beginning and in the end of the intervention using a spirometer
Time Frame
From the first day of evaluation and at eight weeks of the beginning of the intervention
Title
Voluntary maximum ventilation
Description
The change of the voluntary maximum ventilation from the beginning and at the end of the intervention using a spirometer
Time Frame
From the first day of evaluation and at eight weeks of the beginning of the intervention
Title
The "Berg balance scale" Test
Description
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.
Time Frame
From the first day of evaluation and at Eight weeks of the beginning of the intervention
Title
The postural assessment scale for stroke patients (PASS )test
Description
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.
Time Frame
From the first day of evaluation and at Eight weeks of the beginning of the intervention
Title
Trunk control test (TCT)
Description
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
Time Frame
From the first day of evaluation and at Eight weeks of the beginning of the intervention
Secondary Outcome Measure Information:
Title
Quadriceps dynamometry
Description
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
Time Frame
From the first day of evaluation and at eight weeks of the beginning of the intervention
Title
"Functional ambulatory classificator" Test
Description
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
Time Frame
From the first day of evaluation and at Eight weeks of the beginning of the intervention
Title
"Functional ambulatory classificator Hospital de Sagunto" Test
Description
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
Time Frame
From the first day of evaluation and at Eight weeks of the beginning of the intervention
Title
SF-36 health survey
Description
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
Time Frame
From the first day of evaluation and at eight weeks of the beginning of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ALICIA TOVAR ALCARAZ, MS
Phone
+34606160702
Email
aliciatovar78@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
SILVANA L DE OLIVEIRA SOUSA, PhD
Phone
+34687184400
Email
soliveira@umh.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARTHA C LEON GARZON, PhD
Organizational Affiliation
UNIVERSIDAD SAN ANTONIO DE MURCIA
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
SILVANA L DE OLIVEIRA SOUSA, PhD
Organizational Affiliation
Universidad Miguel Hernandez, Elche
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
ALICIA TOVAR ALCARAZ, Pt
Organizational Affiliation
Hospital Universitario Virgen de la Arrixaca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alicia Tovar Alcaraz
City
Murcia
ZIP/Postal Code
30009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ALICIA TOVAR ALCARAZ, Pt
Phone
+34606160702
Email
aliciatovar78@hotmail.com
First Name & Middle Initial & Last Name & Degree
SILVANA L DE OLIVEIRA SOUSA, PhD
Phone
+34687184400
Email
soliveira@umh.es
First Name & Middle Initial & Last Name & Degree
ALICIA TOVAR ALCARAZ, Pt
First Name & Middle Initial & Last Name & Degree
SILVANA L DE OLIVEIRA SOUSA, PhD
First Name & Middle Initial & Last Name & Degree
MARTHA C LEON GARZON, PhD
First Name & Middle Initial & Last Name & Degree
MARIA J GONZALEZ CARRILLO, Pt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The individual participant data includes the spirometry data
Citations:
PubMed Identifier
26180145
Citation
Messaggi-Sartor M, Guillen-Sola A, Depolo M, Duarte E, Rodriguez DA, Barrera MC, Barreiro E, Escalada F, Orozco-Levi M, Marco E. Inspiratory and expiratory muscle training in subacute stroke: A randomized clinical trial. Neurology. 2015 Aug 18;85(7):564-72. doi: 10.1212/WNL.0000000000001827. Epub 2015 Jul 15.
Results Reference
result
PubMed Identifier
20156979
Citation
Sutbeyaz ST, Koseoglu F, Inan L, Coskun O. Respiratory muscle training improves cardiopulmonary function and exercise tolerance in subjects with subacute stroke: a randomized controlled trial. Clin Rehabil. 2010 Mar;24(3):240-50. doi: 10.1177/0269215509358932. Epub 2010 Feb 15.
Results Reference
result
PubMed Identifier
25503549
Citation
Kulnik ST, Birring SS, Moxham J, Rafferty GF, Kalra L. Does respiratory muscle training improve cough flow in acute stroke? Pilot randomized controlled trial. Stroke. 2015 Feb;46(2):447-53. doi: 10.1161/STROKEAHA.114.007110. Epub 2014 Dec 11.
Results Reference
result
PubMed Identifier
26258451
Citation
Kim CY, Lee JS, Kim HD, Kim IS. Effects of the combination of respiratory muscle training and abdominal drawing-in maneuver on respiratory muscle activity in patients with post-stroke hemiplegia: a pilot randomized controlled trial. Top Stroke Rehabil. 2015 Aug;22(4):262-70. doi: 10.1179/1074935714Z.0000000020. Epub 2015 Feb 18.
Results Reference
result
PubMed Identifier
28265169
Citation
Jung KM, Bang DH. Effect of inspiratory muscle training on respiratory capacity and walking ability with subacute stroke patients: a randomized controlled pilot trial. J Phys Ther Sci. 2017 Feb;29(2):336-339. doi: 10.1589/jpts.29.336. Epub 2017 Feb 24.
Results Reference
result

Learn more about this trial

Inspiratory Muscle Training in Patients With Stroke in Subacute Phase.

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