Inspiratory Muscle Training in Patients With Stroke in Subacute Phase.

NCT ID: NCT03800485

Last Updated: 2019-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-20

Study Completion Date

2019-12-30

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.

Conditions

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Stroke Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There are two groups, the intervention group and the placebo group.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
The study is blinded so neither the patient, neither the psysical therapist nor the investigator knows in which group the patient is

Study Groups

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IMT-GE

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.

Group Type EXPERIMENTAL

IMT

Intervention Type 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-GP

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

Group Type PLACEBO_COMPARATOR

IMT

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role collaborator

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role collaborator

Hospital Universitario Virgen de la Arrixaca

OTHER

Sponsor Role lead

Responsible Party

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Alicia Tovar Alcaraz

Physical therapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MARTHA C LEON GARZON, PhD

Role: STUDY_DIRECTOR

UNIVERSIDAD SAN ANTONIO DE MURCIA

SILVANA L DE OLIVEIRA SOUSA, PhD

Role: STUDY_DIRECTOR

Universidad Miguel Hernandez, Elche

ALICIA TOVAR ALCARAZ, Pt

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen de la Arrixaca

Locations

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Alicia Tovar Alcaraz

Murcia, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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ALICIA TOVAR ALCARAZ, MS

Role: CONTACT

+34606160702

SILVANA L DE OLIVEIRA SOUSA, PhD

Role: CONTACT

+34687184400

Facility Contacts

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ALICIA TOVAR ALCARAZ, Pt

Role: primary

+34606160702

SILVANA L DE OLIVEIRA SOUSA, PhD

Role: backup

+34687184400

References

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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.

Reference Type RESULT
PMID: 26180145 (View on PubMed)

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.

Reference Type RESULT
PMID: 20156979 (View on PubMed)

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.

Reference Type RESULT
PMID: 25503549 (View on PubMed)

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.

Reference Type RESULT
PMID: 26258451 (View on PubMed)

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.

Reference Type RESULT
PMID: 28265169 (View on PubMed)

Other Identifiers

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2017-10-4-HCUVA

Identifier Type: -

Identifier Source: org_study_id

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