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
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