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

ISRCTN ISRCTN88161562
DOI https://doi.org/10.1186/ISRCTN88161562
Secondary identifying numbers N0192122294
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
02/11/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr AJ Wills
Scientific

Clinical Neurology
University Hospital
Nottingham
NG7 2UH
United Kingdom

Phone +44 (0)115 924 9924 (41141)
Email adewills61@hotmail.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titlePatterns of respiratory muscle involvement and the effects of respiratory muscle training in muscular dystrophy
Study objectivesWe 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(s)Queens Medical Centre
Health condition(s) or problem(s) studiedRespiratory: Muscular dystrophy
InterventionCase-control study and respiratory muscle training versus sham training RCT
Intervention typeOther
Primary outcome measure1. Respiratory function parameters
2. Time to require home ventilation
3. Mortality
Secondary outcome measuresNo secondary outcome measures
Overall study start date12/09/2003
Completion date30/06/2007

Eligibility

Participant type(s)Mixed
Age groupNot Specified
SexNot Specified
Target number of participants100
Key inclusion criteriaTotal number of subjects = 100; 80 with muscular dystrophy, 20 controls.
Key exclusion criteriaAdded July 2008:
Patients already on ventilation, other neuromuscular conditions apart from inherited muscle diseases.
Date of first enrolment12/09/2003
Date of final enrolment30/06/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University Hospital
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Queens Medical Centre University Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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