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Inspiratory Muscle Training in Patients With Stroke in Subacute Phase.

V

Virgen de la Arrixaca University Clinical Hospital (HCUVA)

Status

Unknown

Conditions

Stroke Rehabilitation

Treatments

Device: IMT

Study type

Interventional

Funder types

Other

Identifiers

NCT03800485
2017-10-4-HCUVA

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

20 participants in 2 patient groups, including a placebo group

IMT-GE
Experimental group
Description:
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.
Treatment:
Device: IMT
IMT-GP
Placebo Comparator group
Description:
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
Treatment:
Device: IMT

Trial contacts and locations

1

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Central trial contact

ALICIA TOVAR ALCARAZ, MS; SILVANA L DE OLIVEIRA SOUSA, PhD

Data sourced from clinicaltrials.gov

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