Inspiratory Training in Amyotrophic Lateral Sclerosis - a phase III, multi-centre, double-blind, randomised-controlled trial

Phase 3

Recruiting

• Conditions: Amyotrophic lateral sclerosis; Motor neuron disease; Neurological - Neurodegenerative diseases

• Registration Number: ACTRN12608000238370
• Lead Sponsor: Australian Rotary Health Research Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

Definite, probable or possible amyotrophic lateral sclerosis according to the revised El Escorial criteria. Disease duration of less than 3 years & sniff nasal inspiratory pressure of equal to or greater than 40% predicted. OR disease duration of more than 3 years & sniff nasal inspiratory pressure less than 40% predicted.

Exclusion Criteria

Patients who anticipate that they will not be able to use the IMT device over the entire training period.
Tracheostomy ventilation or non-invasive ventilation for greater than 14 hours/day.
Diagnosis of a significant co-existing respiratory or neurological illness.
History of an unstable medical condition in the preceding three years.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sniff nasal inspiratory pressure.[Weeks 0, 8, 16, 24 and 32.]

Secondary Outcome Measures

Name	Time	Method
Respiratory function (forced vital capacity, vital capacity, forced expiratory volume in one second)[Weeks 0, 8, 16, 24 and 32.];Health-relatd quality of life (Short Form 36)[Weeks 0, 4, 8, 12, 16, 20, 24, 28 and 32.];Health-related quality of life (Chronic Respiratory Questionnaire)[Weeks 0, 4, 8, 12, 16, 20, 24, 28 and 32.];Grip strength using a handheld Jamar dynamometer[Weeks 0, 4, 8, 12, 16, 20, 24, 28 and 32.];Amyotrophic Lateral Sclerosis Functional Rating Scale-revised[Weeks 0, 4, 8, 12, 16, 20, 24, 28 and 32.];6 minute walk test[Weeks 0, 8, 16, 24 and 32.];Survival[Patient survival will be monitored from the time at which they enter the study till the end of the 32 week training period.]