Condition category
Respiratory
Date applied
07/08/2009
Date assigned
02/10/2009
Last edited
10/07/2014
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

Mrs Pamela de Chazal

ORCID ID

Contact details

Department of Pulmonary Rehabilitation
Glenfield Hospital
Leicester
LE3 9QP
United Kingdom
+44 (0)116 250 2758
pam.dechazal@uhl-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

The REACH trial

Study hypothesis

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

Not provided at time of registration

Study design

Prospective parallel group randomised single blind controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Hospital readmission rate at 12 months

Secondary outcome measures

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

Overall trial start date

01/01/2010

Overall trial end date

30/09/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

484

Participant 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

Recruitment start date

01/01/2010

Recruitment end date

30/09/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Pulmonary Rehabilitation
Leicester
LE3 9QP
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

Headquarters
Gwendolen House
Gwendolen Road
Leicester
LE5 4QF
United Kingdom
+44 (0)116 287 1471
carolyn.maloney@uhl-tr.nhs.uk

Sponsor type

Government

Website

http://www.uhl-tr.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute of Health Research (NIHR) (UK) - Collaboration for Leadership in Applied Health Research and Care - Leicestershire, Northamptonshire and Rutland (CLAHRC LNR)

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25004917

Publication citations

  1. Results

    Greening NJ, Williams JE, Hussain SF, Harvey-Dunstan TC, Bankart MJ, Chaplin EJ, Vincent EE, Chimera R, Morgan MD, Singh SJ, Steiner MC, An early rehabilitation intervention to enhance recovery during hospital admission for an exacerbation of chronic respiratory disease: randomised controlled trial., BMJ, 2014, 349, g4315.

Additional files

Editorial Notes