Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000238370
Ethics application status
Approved
Date submitted
8/05/2008
Date registered
8/05/2008
Date last updated
13/06/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Inspiratory Training in Amyotrophic Lateral Sclerosis - a phase III, multi-centre, double-blind, randomised-controlled trial
Scientific title
Inspiratory muscle training in amyotrophic lateral sclerosis to improve inspiratory muscle strength
Universal Trial Number (UTN)
Trial acronym
2 INSPIRATIonAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Amyotrophic lateral sclerosis 3124 0
Motor neuron disease 3125 0
Condition category
Condition code
Neurological 3288 3288 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 2870 0
Treatment: Devices
Comparator / control treatment
Sham inspiratory muscle training
Control group
Active

Outcomes
Primary outcome [1] 4175 0
Sniff nasal inspiratory pressure.
Timepoint [1] 4175 0
Weeks 0, 8, 16, 24 and 32.
Secondary outcome [1] 7052 0
Respiratory function (forced vital capacity, vital capacity, forced expiratory volume in one second)
Timepoint [1] 7052 0
Weeks 0, 8, 16, 24 and 32.
Secondary outcome [2] 7053 0
Health-relatd quality of life (Short Form 36)
Timepoint [2] 7053 0
Weeks 0, 4, 8, 12, 16, 20, 24, 28 and 32.
Secondary outcome [3] 7054 0
Health-related quality of life (Chronic Respiratory Questionnaire)
Timepoint [3] 7054 0
Weeks 0, 4, 8, 12, 16, 20, 24, 28 and 32.
Secondary outcome [4] 7055 0
Grip strength using a handheld Jamar dynamometer
Timepoint [4] 7055 0
Weeks 0, 4, 8, 12, 16, 20, 24, 28 and 32.
Secondary outcome [5] 7056 0
Amyotrophic Lateral Sclerosis Functional Rating Scale-revised
Timepoint [5] 7056 0
Weeks 0, 4, 8, 12, 16, 20, 24, 28 and 32.
Secondary outcome [6] 7057 0
6 minute walk test
Timepoint [6] 7057 0
Weeks 0, 8, 16, 24 and 32.
Secondary outcome [7] 7058 0
Survival
Timepoint [7] 7058 0
Patient survival will be monitored from the time at which they enter the study till the end of the 32 week training period.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted Block Randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants are blinded to whether they are receiving sham or treatment intervention. The assessor is blinded to whether the participant was in sham or treatment group. Another independent analyst will assess the data and will be blind to whether participants were from sham or treatment groups.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 832 0
2031
Recruitment postcode(s) [2] 833 0
3162
Recruitment postcode(s) [3] 834 0
4029
Recruitment postcode(s) [4] 835 0
2065
Recruitment postcode(s) [5] 836 0
2144

Funding & Sponsors
Funding source category [1] 3366 0
Charities/Societies/Foundations
Name [1] 3366 0
Australian Rotary Health Research Fund
Country [1] 3366 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Rotary Health Research Fund
Address
Australian Rotary Health Research Fund
Floor 2
Rotary Down Under House
43 Hunter Street
PARRAMATTA NSW 2150
Country
Australia
Secondary sponsor category [1] 3013 0
None
Name [1] 3013 0
Address [1] 3013 0
Country [1] 3013 0
Other collaborator category [1] 280 0
Hospital
Name [1] 280 0
Royal Brisbane and Women's Hospital
Address [1] 280 0
Butterfield Street
Herston QLD 4029
Country [1] 280 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5391 0
Northern Sydney Central Coast Area Health Service Human Research Ethics Committee (Harbour)
Ethics committee address [1] 5391 0
Research Office
Level 4, Vindin House
Royal North Shore Hospital
Pacific Highway
St. Leonards
NSW 2065
Ethics committee country [1] 5391 0
Australia
Date submitted for ethics approval [1] 5391 0
18/02/2008
Approval date [1] 5391 0
01/05/2008
Ethics approval number [1] 5391 0
0803-021M

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28576 0
Address 28576 0
Country 28576 0
Phone 28576 0
Fax 28576 0
Email 28576 0
Contact person for public queries
Name 11733 0
Associate Professor Matthew Kiernan
Address 11733 0
Institute of Neurological Sciences
Prince of Wales Hospital
NSW 2031
Country 11733 0
Australia
Phone 11733 0
(02) 9382 2422
Fax 11733 0
(02) 9382 2437
Email 11733 0
[email protected]
Contact person for scientific queries
Name 2661 0
Associate Professor Matthew Kiernan
Address 2661 0
Institute of Neurological Sciences
Prince of Wales Hospital
NSW 2031
Country 2661 0
Australia
Phone 2661 0
(02) 9382 2422
Fax 2661 0
(02) 9382 2437
Email 2661 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.