Inspiratory Muscle Training in Patients With Stroke in Subacute Phase.

Stroke Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03800485
• Other study ID #: 2017-10-4-HCUVA
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2019
• Source: Hospital Universitario Virgen de la Arrixaca
• Contact: ALICIA TOVAR ALCARAZ, MS
• Phone: +34606160702
• Email: aliciatovar78[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Aspiration
• Stroke
• Stroke Rehabilitation

Intervention

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

Locations

Country	Name	City	State
Spain	Alicia Tovar Alcaraz	Murcia

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Universitario Virgen de la Arrixaca	Universidad Católica San Antonio de Murcia, Universidad Miguel Hernandez de Elche

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View 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. 20 — View 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. — View Citation

Messaggi-Sartor M, Guillen-Solà A, Depolo M, Duarte E, Rodríguez 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):564-7 — View 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: 10.1177/026921550935 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	"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
Secondary	"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
Secondary	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