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Inspiratory Muscle Training in Patients With Stroke in Subacute Phase.

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03800485
Enrollment
20
Registered
2019-01-11
Start date
2019-01-20
Completion date
2019-12-30
Last updated
2019-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke Rehabilitation

Keywords

stroke, respiratory muscles, lung, stroke rehabilitation

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.

Interventions

DEVICEIMT

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

Sponsors

Universidad Católica San Antonio de Murcia
CollaboratorOTHER
Universidad Miguel Hernandez de Elche
CollaboratorOTHER
Hospital Universitario Virgen de la Arrixaca
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

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

Intervention model description

There are two groups, the intervention group and the placebo group.

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Trunk control test (TCT)From the first day of evaluation and at Eight weeks of the beginning of the interventionThe 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
Forzed espiratory volume in the first secondFrom the first day of evaluation and at eight weeks of the beginning of the interventionThe change of the forzed espiratory volumen in the first second beginning and in the end of the intervention using a spirometer
Voluntary maximum ventilationFrom the first day of evaluation and at eight weeks of the beginning of the interventionThe change of the voluntary maximum ventilation from the beginning and at the end of the intervention using a spirometer
The Berg balance scale TestFrom the first day of evaluation and at Eight weeks of the beginning of the interventionThe 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.
The postural assessment scale for stroke patients (PASS )testFrom the first day of evaluation and at Eight weeks of the beginning of the interventionThe 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.
Maximum inspiratory pressureFrom the first day of evaluation and at eight weeks of the beginning of the interventionThe change of the maximum inspiratory pressure from the beginning, at 4 weeks and At 8 weeks
Forzed vital capacityFrom the first day of evaluation and at eight weeks of the beginning of the interventionThe change of the forzed vital capacity from the beginning and at the end of the intervention

Secondary

MeasureTime frameDescription
Functional ambulatory classificator TestFrom the first day of evaluation and at Eight weeks of the beginning of the interventionThe 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
Functional ambulatory classificator Hospital de Sagunto TestFrom the first day of evaluation and at Eight weeks of the beginning of the interventionThe 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
SF-36 health surveyFrom the first day of evaluation and at eight weeks of the beginning of the interventionThe 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
Quadriceps dynamometryFrom the first day of evaluation and at eight weeks of the beginning of the interventionThe 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

Countries

Spain

Contacts

Primary ContactALICIA TOVAR ALCARAZ, MS
aliciatovar78@hotmail.com+34606160702
Backup ContactSILVANA L DE OLIVEIRA SOUSA, PhD
soliveira@umh.es+34687184400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026