Non-invasive ventilation (NIV) as an aid to rehabilitation in acute respiratory disease
| ISRCTN | ISRCTN35692743 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35692743 |
| Secondary identifying numbers | V1 |
- Submission date
- 22/11/2010
- Registration date
- 25/11/2010
- Last edited
- 15/05/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Nicholas Hopkinson
Scientific
Scientific
Royal Brompton Hospital
Fulham Rd
London
SW3 6NP
United Kingdom
Study information
| Study design | Prospective single blind randomised controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Non-invasive ventilation (NIV) as an aid to rehabilitation in acute respiratory disease: A prospective, single-blind, randomised controlled trial |
| Study hypothesis | We wish to establish if it is feasible and effective to deliver NIV-assisted exercise, before the patient has recovered sufficiently to exercise in a conventional unassisted fashion, aiming to prevent loss of muscle function during acute admissions to hospital. |
| Ethics approval(s) | Approved by South West London Research Ethics Committee 1 on the 1st of November 2010 (ref: 10-H0801-44) |
| Condition | Acute exacerbation of chronic obstructive pulmonary disease (COPD) |
| Intervention | Patients will be randomised to one of three arms 1. Usual care 2. 1 hour per day of physiotherapy input including cycle exercise 3. 1 hour per day of exercise using NIV to support breathing |
| Intervention type | Other |
| Primary outcome measure | Quadriceps strength measured as quadriceps isometric maximum voluntary contraction force using a dynamometer at 2 weeks after discharge. |
| Secondary outcome measures | 1. COPD Assessment Test (CAT) score 2. St George's Respiratory Questionnaire (SGRQ) 3. Physical activity monitored with SenseWear armband 4. Acceptability of treatment 5. Incremental shuttle walk test distance All secondary outcomes will be assessed at baseline, discharge from hospital and 2 weeks post discharge. |
| Overall study start date | 01/12/2010 |
| Overall study end date | 01/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 45 |
| Participant inclusion criteria | 1. Adult patient admitted with an acute exacerbation of COPD 2. Expected to be in hospital for at least 24 hours |
| Participant exclusion criteria | 1. Patients who are not expected to survive the admission 2. Patients with significant co-morbidity which is thought to be the major factor limiting their exercise capacity 3. Inability to understand instructions or use an exercise bike |
| Recruitment start date | 01/12/2010 |
| Recruitment end date | 01/06/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Brompton Hospital
London
SW3 6NP
United Kingdom
SW3 6NP
United Kingdom
Sponsor information
Imperial College London (UK)
Not defined
Not defined
c/o Gary Roper
Imperial College Clincial Research Office
Room G02
SAF Building
S Ken Campus
London
SW7 2AZ
United Kingdom
"ROR" |
https://ror.org/041kmwe10 |
|---|
Funders
Funder type
Government
National Institute of Health Research (NIHR) Respiratory Biomedical Research Unit (BRU) (UK) - run jointly by:
No information available
Royal Brompton & Harefield NHS Foundation Trust (UK)
No information available
Imperial College London, National Heart & Lung Institute (NHLI) (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 16/12/2011 | Yes | No |
