Condition category
Nervous System Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
30/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr WJ Kinnear

ORCID ID

Contact details

Department of Medicine
D Floor South Block
University Hospital
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 924 9924 (41979)

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0192107577

Study information

Scientific title

Acronym

Study hypothesis

Does expiratory muscle training in motor neurone disease:
1. Increase expiratory muscle strength?
2. Improve cough efficacy?
3. Have any beneficial effect on survival?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Motor neurone disease (MND)

Intervention

Randomised controlled trial.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Vital capacity <50% predicted, onset of respiratory failure (PaCO2 >6), death.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

12/02/2002

Overall trial end date

13/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Total number of subjects = 24.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

24

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

12/02/2002

Recruitment end date

13/06/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Medicine
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Queens Medical Centre University Hospital NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes