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| Name | Class |
|---|---|
| Universidad Católica San Antonio de Murcia | OTHER |
| Universidad Miguel Hernandez de Elche | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMT-GE | Experimental | 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. |
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| IMT-GP | Placebo Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMT | Device | 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 |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ALICIA TOVAR ALCARAZ, MS | Contact | +34606160702 | aliciatovar78@hotmail.com | |
| SILVANA L DE OLIVEIRA SOUSA, PhD | Contact | +34687184400 | soliveira@umh.es |
| Name | Affiliation | Role |
|---|---|---|
| MARTHA C LEON GARZON, PhD | UNIVERSIDAD SAN ANTONIO DE MURCIA | Study Director |
| SILVANA L DE OLIVEIRA SOUSA, PhD | Universidad Miguel Hernandez de Elche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alicia Tovar Alcaraz | Recruiting | Murcia | 30009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26180145 | Result | 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. | |
| 20156979 | Result |
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The individual participant data includes the spirometry data
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 17, 2022 | |
| Reset | Apr 28, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 17, 2022 | Apr 28, 2022 |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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There are two groups, the intervention group and the placebo group.
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The study is blinded so neither the patient, neither the psysical therapist nor the investigator knows in which group the patient is
| 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 |
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 |
| ALICIA TOVAR ALCARAZ, Pt |
| Hospital Universitario Virgen de la Arrixaca |
| Principal Investigator |
| 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. |
| 25503549 | Result | 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. |
| 26258451 | Result | 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. |
| 28265169 | Result | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |