Status:

TERMINATED

Equivalence Test of Two Different Inspiratory Muscle Training Protocols: a Randomised Controlled Trial

Lead Sponsor:

Spinal Cord Injury Centre of Western Denmark

Collaborating Sponsors:

Rigshospitalet, Denmark

Conditions:

Inspiratory Muscle Training

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The objective of this study is to investigate if six weeks of high intensity Inspiratory Muscle Training (IMT) performed two times a week has the same effect as five times a week in hospitalized patie...

Detailed Description

Background: SCI may result in various disabilities including both physical, cognitive, emotional and social domains. Motor function and function of the respiratory muscles are often decreased and may ...

Eligibility Criteria

Inclusion

  • First time SCI within 0-6 months
  • Age ≥ 18 years
  • Neurological level: C4 -TH12 and C1-C4 (AIS D only)
  • Severity/ AIS: A, B, C or D
  • Able to give informed concent and understand and read Danish
  • Mental able to understand and participate in a lung function assessment
  • Decreased MIP according to normal gender and age adjusted MIP values

Exclusion

  • Lung disease or lung infection at the time of inclusion
  • Co-morbidity or other contra indications
  • Injury that hinder mouth shutting
  • Respirator or tracheal tube use
  • Experience of severe dizziness or vomiting during training
  • Not expected to be hospitalised for at least 6 weeks

Key Trial Info

Start Date :

January 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2023

Estimated Enrollment :

6 Patients enrolled

Trial Details

Trial ID

NCT05300074

Start Date

January 1 2023

End Date

December 1 2023

Last Update

April 17 2024

Active Locations (1)

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Spinal cord injury center Western Denmark

Viborg, Denmark, 8800