Patterns of respiratory muscle involvement and the effects of respiratory muscle training in muscular dystrophy
| ISRCTN | ISRCTN88161562 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88161562 |
| Protocol serial number | N0192122294 |
| Sponsor | Department of Health (UK) |
| Funder | Queens Medical Centre University Hospital NHS Trust (UK) |
- 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
Scientific
Clinical Neurology
University Hospital
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 (0)115 924 9924 (41141) |
|---|---|
| adewills61@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Patterns of respiratory muscle involvement and the effects of respiratory muscle training in muscular dystrophy |
| Study objectives | 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(s) | Queens Medical Centre |
| Health condition(s) or problem(s) studied | Respiratory: Muscular dystrophy |
| Intervention | Case-control study and respiratory muscle training versus sham training RCT |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Respiratory function parameters |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 30/06/2007 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 100 |
| Key inclusion criteria | Total number of subjects = 100; 80 with muscular dystrophy, 20 controls. |
| Key exclusion criteria | Added July 2008: Patients already on ventilation, other neuromuscular conditions apart from inherited muscle diseases. |
| Date of first enrolment | 12/09/2003 |
| Date of final enrolment | 30/06/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University Hospital
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/11/2016: No publications found, verifying study status with principal investigator.
