Can rehabilitation delivered immediately on hospitalisation for an acute exacerbation of chronic respiratory disease improve long term health outcomes?

ISRCTN	ISRCTN05557928
DOI	https://doi.org/10.1186/ISRCTN05557928
Protocol serial number	N/A
Sponsor	University Hospitals of Leicester NHS Trust (UK)
Funder	National Institute of Health Research (NIHR) (UK) - Collaboration for Leadership in Applied Health Research and Care - Leicestershire, Northamptonshire and Rutland (CLAHRC LNR)

Submission date: 07/08/2009
Registration date: 02/10/2009
Last edited: 10/07/2014

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

Mrs Pamela de Chazal
Scientific

Department of Pulmonary Rehabilitation
Glenfield Hospital
Leicester
LE3 9QP
United Kingdom

Phone	+44 (0)116 250 2758
Email	pam.dechazal@uhl-tr.nhs.uk

Study information

Primary study design	Interventional
Study design	Prospective parallel group randomised single blind controlled clinical trial
Secondary study design	Randomised controlled trial
Scientific title	Can rehabilitation delivered immediately on hospitalisation for an acute exacerbation of chronic respiratory disease improve long term health outcomes? A randomised controlled trial
Study acronym	The REACH trial
Study objectives	The hypothesis is that an early and proactive rehabilitation strategy which is delivered immediately on hospitalisation for an acute exacerbation of chronic respiratory disease will prevent the decline in physical function associated with the exacerbation, improve clinical outcomes and reduce the risk of subsequent hospitalisation.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Chronic respiratory disease
Intervention	Treatment for patients in the intervention group will start within 48 hours of admission for an acute exacerbation of chronic respiratory disease. It will take the form of a daily, individually prescribed, graduated exercise and strength training programme and will continue until discharge. After discharge, patients will continue a home-based customised rehabilitation programme for six weeks. Patients in the control group will receive 'best usual care' from the medical, nursing, physiotherapy and occupational therapy teams.
Intervention type	Other
Primary outcome measure(s)	Hospital readmission rate at 12 months
Key secondary outcome measure(s)	1. Exercise capacity, measured at discharge home, 6 weeks after randomisation, 6 months after discharge and 12 months after discharge 2. Health status, measured at discharge home, 6 weeks after randomisation, 6 months after discharge and 12 months after discharge 3. Psychological wellbeing, measured at discharge home, 6 weeks after randomisation, 6 months after discharge and 12 months after discharge 4. Muscle strength and thickness, measured at discharge home, 6 weeks after randomisation, 6 months after discharge and 12 months after discharge 5. Biomarkers, measured at discharge home, 6 weeks after randomisation, 6 months after discharge and 12 months after discharge 6. Spirometry, measured at discharge home, 6 weeks after randomisation, 6 months after discharge and 12 months after discharge 7. Length of stay, measured at discharge home 8. Nutritional status, measured at 6 weeks after randomisation, 6 months after discharge and 12 months after discharge 9. Muscle structure changes, measured at 6 weeks after randomisation, 6 months after discharge and 12 months after discharge 10. Focus groups for psychological analysis, measured at 12 months after discharge 11. Healthcare utilisation, measured at 12 months after discharge
Completion date	30/09/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	484
Key inclusion criteria	1. Patients aged 40 and over of either sex who are admitted to hospital with an acute exacerbation of chronic respiratory disease 2. Ability to give informed consent
Key exclusion criteria	1. Musculoskeletal or neuromuscular conditions that significantly contribute to exercise limitation 2. Psychiatric or neurological conditions that render the patient unable to comply with the rehabilitation programme 3. Not living independently at the time of admission 4. Admission for an acute myocardial infarction 5. Terminal disease with an estimated survival time of less than three months 6. Four or more hospitalisations for acute exacerbations of chronic respiratory disease in the preceding 12 month period
Date of first enrolment	01/01/2010
Date of final enrolment	30/09/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Pulmonary Rehabilitation

Leicester
LE3 9QP
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	08/07/2014		Yes	No