Non-invasive ventilation (NIV) as an aid to rehabilitation in acute respiratory disease

ISRCTN	ISRCTN35692743
DOI	https://doi.org/10.1186/ISRCTN35692743
Protocol serial number	V1
Sponsor	Imperial College London (UK)
Funders	National Institute of Health Research (NIHR) Respiratory Biomedical Research Unit (BRU) (UK) - run jointly by:, Royal Brompton & Harefield NHS Foundation Trust (UK), Imperial College London, National Heart & Lung Institute (NHLI) (UK)

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 of protocol

Not provided at time of registration

Contact information

Dr Nicholas Hopkinson
Scientific

Royal Brompton Hospital
Fulham Rd
London
SW3 6NP
United Kingdom

Study information

Primary study design	Interventional
Study design	Prospective single blind randomised controlled parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	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)
Health condition(s) or problem(s) studied	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(s)	Quadriceps strength measured as quadriceps isometric maximum voluntary contraction force using a dynamometer at 2 weeks after discharge.
Key secondary outcome measure(s)	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.
Completion date	01/06/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	45
Key inclusion criteria	1. Adult patient admitted with an acute exacerbation of COPD 2. Expected to be in hospital for at least 24 hours
Key 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
Date of first enrolment	01/12/2010
Date of final enrolment	01/06/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Royal Brompton Hospital

London
SW3 6NP
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?
Results article	results	16/12/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes