Condition category
Respiratory
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
02/11/2016
Prospective/Retrospective
Prospectively 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 AJ Wills

ORCID ID

Contact details

Clinical Neurology
University Hospital
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 924 9924 (41141)
adewills61@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0192122294

Study information

Scientific title

Patterns of respiratory muscle involvement and the effects of respiratory muscle training in muscular dystrophy

Acronym

Study hypothesis

We aim to determine the patterns of respiratory involvement in various inherited neuromuscular diseases. We will aim to quantify the utility of various parameters in assessing respiratory function and determine the measurements which might have reliable prognostic significance. These studies will be cross-sectional and longitudinal. In addition, in certain sub-groups we will undertake a randomised controlled trial to assess the effect of respiratory muscle training versus sham training. We will also aim to measure the effects of home oximetry and prophylactic antibiotics in patients with a low vital capacity.

Ethics approval

Queens Medical Centre

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Respiratory: Muscular dystrophy

Intervention

Case-control study and respiratory muscle training versus sham training RCT

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Respiratory function parameters
2. Time to require home ventilation
3. Mortality

Secondary outcome measures

No secondary outcome measures

Overall trial start date

12/09/2003

Overall trial end date

30/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Total number of subjects = 100; 80 with muscular dystrophy, 20 controls.

Participant type

Mixed

Age group

Not Specified

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

Added July 2008:
Patients already on ventilation, other neuromuscular conditions apart from inherited muscle diseases.

Recruitment start date

12/09/2003

Recruitment end date

30/06/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital
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

Government

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

02/11/2016: No publications found, verifying study status with principal investigator.