Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000258459
Ethics application status
Approved
Date submitted
23/04/2007
Date registered
15/05/2007
Date last updated
15/05/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study investigating training of respiratory muscles for MND?
Scientific title
Does respiratory function in patients with Motor Neurone Disease improve in response to inspiratory training compared with sham training.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Function in patients with Motor Neurone Disease 1797 0
Condition category
Condition code
Respiratory 1883 1883 0 0
Normal development and function of the respiratory system
Neurological 1884 1884 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The training group will complete a standardized 3 month period of respiratory training using a threshold inspiratory muscle trainer. Participants will train 3 times each day for 10 minutes each session. Training pressure will be set at a minimum target % of maximum inspiratory pressure. Participants will be trained in the use of the device and will perform daily training. Participants will be assessed every 2 weeks when training pressure will be adjusted accordingly to maintain the target pressure.
Intervention code [1] 1717 0
Treatment: Other
Comparator / control treatment
Control patients will use a modified device that does not affect airway resistance or pressure.
Control group
Placebo

Outcomes
Primary outcome [1] 2674 0
Upright Forced Vital Capacity (UFVC)
Timepoint [1] 2674 0
Measured within 4 weeks (week 0), at week 12 and week 24.
Primary outcome [2] 2675 0
Maximal inspiratory and expiratory flow-volume curves (MIFVC and MEFVC)
Timepoint [2] 2675 0
Measured within 4 weeks (week 0), at week 12 and week 24.
Primary outcome [3] 2676 0
Single breath pulmonary diffusing capacity (SBPDC)
Timepoint [3] 2676 0
Measured within 4 weeks (week 0), at week 12 and week 24.
Primary outcome [4] 2677 0
Earlobe capillary blood gases (ELBG) breathing room air
Timepoint [4] 2677 0
Measured within 4 weeks (week 0), at week 12 and week 24.
Primary outcome [5] 2678 0
Max Inspiratory Pressure (MIP)
Timepoint [5] 2678 0
Measured within 4 weeks (week 0), at week 4, week 8, week 12 and week 24.
Primary outcome [6] 2679 0
Max Expiratory Pressure (MEP)
Timepoint [6] 2679 0
Measured within 4 weeks (week 0), at week 4, week 8, week 12 and week 24.
Primary outcome [7] 2680 0
Sniff Nasal Inspiratory Pressure (SNIP)
Timepoint [7] 2680 0
Measured within 4 weeks (week 0), at week 4, week 8, week 12 and week 24.
Secondary outcome [1] 4533 0
Secondary outcomes of Neurophysiological Index (NI), Amytrophic Lateral Scelosis Functional Ratings Scale - Revised (ALSFRS-R), 6 minute walk test (6MWT), standardised dyspnoea scale (SDS), Grip Strength (GS).
Timepoint [1] 4533 0
Baseline outcomes will be measured within 4 weeks prior to commencement of training (= week 0).
At weeks 12 and 24, repeat outcomes for all of the above will be taken.
Secondary outcome [2] 4534 0
The Short Form 36 Quality of Life Questionnaire
Timepoint [2] 4534 0
Administered at weeks 0, 4, 8, 12 and 24.

Eligibility
Key inclusion criteria
Volunteers with MND diagnosed by a Neurologist, using results from neurophsyiological, and clinical examinations, and the revised El Escorial criteria. And volunteers must be able to attend the Prince of Wales Hospital, Randwick.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants unable to train due to MND disease state; presence of any other co-existing significant respiratory, neurological or malignant disease processes.

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. Therapists administering training are blinded to whether participants are in sham or treatment groups. The assessor (different to therapist) 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 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2032 0
Other
Name [1] 2032 0
Prince of Wales Medical Research Institute
Country [1] 2032 0
Australia
Primary sponsor type
Other
Name
Associate Professor Matthew Kiernan and the Prince of Wales Medical Research Institute.
Address
Country
Australia
Secondary sponsor category [1] 1840 0
Individual
Name [1] 1840 0
Dr Robert Boland from Prince of Wales Medical Research Institute
Address [1] 1840 0
Country [1] 1840 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3764 0
South Eastern Sydney Area Health Service
Ethics committee address [1] 3764 0
Ethics committee country [1] 3764 0
Australia
Date submitted for ethics approval [1] 3764 0
Approval date [1] 3764 0
30/08/2006
Ethics approval number [1] 3764 0
06/203

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

Contacts
Principal investigator
Name 27820 0
Address 27820 0
Country 27820 0
Phone 27820 0
Fax 27820 0
Email 27820 0
Contact person for public queries
Name 10906 0
Associate Professor Matthew Kiernan
Address 10906 0
Prince of Wales Hospital, Institute of Neurological Sciences, High St, Randwick, NSW 2031
Country 10906 0
Australia
Phone 10906 0
93822422
Fax 10906 0
93822437
Email 10906 0
[email protected]
Contact person for scientific queries
Name 1834 0
Associate Professor Matthew Kiernan
Address 1834 0
Prince of Wales Hospital
Institute of Neurological Sciences
High St
Randwick NSW 2031
Country 1834 0
Australia
Phone 1834 0
93822422
Fax 1834 0
93822437
Email 1834 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.