Inspiratory Muscle Training in Patients With Stroke in Subacute Phase.

NCT03800485 | Unknown DMC

• 1 other identifier: 2017-10-4-HCUVA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke Rehabilitation

Keywords

stroke; respiratory muscles; lung; stroke rehabilitation

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (4)

• Quadriceps dynamometry

  From the first day of evaluation and at eight weeks of the beginning of the intervention

• "Functional ambulatory classificator" Test

  From the first day of evaluation and at Eight weeks of the beginning of the intervention

• "Functional ambulatory classificator Hospital de Sagunto" Test

  From the first day of evaluation and at Eight weeks of the beginning of the intervention

• SF-36 health survey

  From the first day of evaluation and at eight weeks of the beginning of the intervention

Study Arms (2)

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.

Device: IMT

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

Device: IMT

Interventions

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

IMT-GE; IMT-GP

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Virgen de la Arrixaca: lead
• Universidad Católica San Antonio de Murcia: collaborator
• Universidad Miguel Hernandez de Elche: collaborator

Study Sites (1)

Alicia Tovar Alcaraz

Murcia, 30009, Spain

RECRUITING

Related Publications (5)

• 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.

  PMID: 26180145 RESULT

• 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.

  PMID: 20156979 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.

  PMID: 25503549 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.

  PMID: 26258451 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.

  PMID: 28265169 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• MARTHA C LEON GARZON, PhD

  UNIVERSIDAD SAN ANTONIO DE MURCIA

  STUDY DIRECTOR

• SILVANA L DE OLIVEIRA SOUSA, PhD

  Universidad Miguel Hernandez, Elche

  STUDY DIRECTOR

• ALICIA TOVAR ALCARAZ, Pt

  Hospital Universitario Virgen de la Arrixaca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ALICIA TOVAR ALCARAZ, MS

CONTACT

+34606160702; aliciatovar78@hotmail.com

SILVANA L DE OLIVEIRA SOUSA, PhD

CONTACT

+34687184400; soliveira@umh.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The study is blinded so neither the patient, neither the psysical therapist nor the investigator knows in which group the patient is
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical therapist

Model Details: There are two groups, the intervention group and the placebo group.

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: January 11, 2019
• Study Start: January 20, 2019
• Primary Completion: November 30, 2019
• Study Completion: December 30, 2019
• Last Updated: January 11, 2019

Record last verified: 2019-01

Locations

ES (1)