Inspiratory Muscle Training in Patients With Stroke in Subacute Phase.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stroke Rehabilitation

Intervention / Treatment
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* Device: IMT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There are two groups, the intervention group and the placebo group.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMT-GE<br>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<br>* 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<br>|
| Placebo Comparator: IMT-GP<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum inspiratory pressure | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, respiratory muscles, lung, stroke rehabilitation