Condition category
Respiratory
Date applied
22/11/2010
Date assigned
25/11/2010
Last edited
15/05/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nicholas Hopkinson

ORCID ID

Contact details

Royal Brompton Hospital
Fulham Rd
London
SW3 6NP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V1

Study information

Scientific title

Non-invasive ventilation (NIV) as an aid to rehabilitation in acute respiratory disease: A prospective, single-blind, randomised controlled trial

Acronym

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

Approved by South West London Research Ethics Committee 1 on the 1st of November 2010 (ref: 10-H0801-44)

Study design

Prospective single blind randomised controlled parallel group 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 the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/12/2010

Overall trial end date

01/06/2011

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

45

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

United Kingdom

Trial participating centre

Royal Brompton Hospital
London
SW3 6NP
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

c/o Gary Roper
Imperial College Clincial Research Office
Room G02
SAF Building
S Ken Campus
London
SW7 2AZ
United Kingdom

Sponsor type

Not defined

Website

Funders

Funder type

Government

Funder name

National Institute of Health Research (NIHR) Respiratory Biomedical Research Unit (BRU) (UK) - run jointly by:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Royal Brompton & Harefield NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Imperial College London, National Heart & Lung Institute (NHLI) (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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22177338

Publication citations

  1. Results

    Dyer F, Flude L, Bazari F, Jolley C, Englebretsen C, Lai D, Polkey MI, Hopkinson NS, Non-invasive ventilation (NIV) as an aid to rehabilitation in acute respiratory disease., BMC Pulm Med, 2011, 11, 58, doi: 10.1186/1471-2466-11-58.

Additional files

Editorial Notes