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

Inspiratory muscle training in amyotrophic lateral sclerosis to improve inspiratory muscle strength

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000238370

Acronym

2 INSPIRATIonAL

Enrollment

126

Registered

2008-05-08

Start date

2008-05-09

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Interventions

Inspiratory muscle training - similar to resistance training of limb muscles except the target muscle group is the inspiratory muscles. Inspiratory muscle training involves inhaling through an threshold inspiratory muscle training device for 10 minutes, three times per day for 32 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

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.

Outcome results