Clinical trial NCT03800485: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke Rehabilitation
Keywords: stroke
respiratory muscles
lung
stroke rehabilitation
Lead sponsor: Hospital Universitario Virgen de la Arrixaca
Sponsor class: OTHER
Collaborators: name: Universidad Católica San Antonio de Murcia
name: Universidad Miguel Hernandez de Elche
First posted: 2019-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two groups, the intervention group and the placebo group.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Maximum inspiratory pressure
timeFrame: From the first day of evaluation and at eight weeks of the beginning of the intervention
measure: Forzed vital capacity
timeFrame: From the first day of evaluation and at eight weeks of the beginning of the intervention
measure: Forzed espiratory volume in the first second
timeFrame: From the first day of evaluation and at eight weeks of the beginning of the intervention
measure: Voluntary maximum ventilation
timeFrame: From the first day of evaluation and at eight weeks of the beginning of the intervention
measure: The "Berg balance scale" Test
timeFrame: From the first day of evaluation and at Eight weeks of the beginning of the intervention
measure: The postural assessment scale for stroke patients (PASS )test
timeFrame: From the first day of evaluation and at Eight weeks of the beginning of the intervention
measure: Trunk control test (TCT)
timeFrame: From the first day of evaluation and at Eight weeks of the beginning of the intervention
Secondary outcomes:
measure: Quadriceps dynamometry
timeFrame: From the first day of evaluation and at eight weeks of the beginning of the intervention
measure: "Functional ambulatory classificator" Test
timeFrame: From the first day of evaluation and at Eight weeks of the beginning of the intervention
measure: "Functional ambulatory classificator Hospital de Sagunto" Test
timeFrame: From the first day of evaluation and at Eight weeks of the beginning of the intervention
measure: SF-36 health survey
timeFrame: From the first day of evaluation and at eight weeks of the beginning of the intervention
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Alicia Tovar Alcaraz
Study officials:
affiliation: UNIVERSIDAD SAN ANTONIO DE MURCIA
name: MARTHA C LEON GARZON, PhD
role: STUDY_DIRECTOR
affiliation: Universidad Miguel Hernandez, Elche
name: SILVANA L DE OLIVEIRA SOUSA, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Virgen de la Arrixaca
name: ALICIA TOVAR ALCARAZ, Pt
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.