Maintenance schedules following pulmonary rehabilitation

ISRCTN	ISRCTN68654480
DOI	https://doi.org/10.1186/ISRCTN68654480
ClinicalTrials.gov (NCT)	NCT00925171
Protocol serial number	7914
Sponsor	Norfolk and Norwich University Hospital NHS Foundation Trust (UK)
Funder	National Institute for Health Research

Submission date: 23/04/2010
Registration date: 23/04/2010
Last edited: 10/06/2015

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 Andrew M Wilson
Scientific

University of East Anglia
Biomedical Research Centre
Norwich
NR4 7TJ
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised interventional treatment trial
Secondary study design	Randomised controlled trial
Scientific title	The effects of maintenance schedules following pulmonary rehabilitation in patients with chronic obstructive pulmonary disease
Study objectives	The primary aim is to compare the effectiveness of maintenance pulmonary rehabilitation (PR) sessions at 3, 6 and 9 months following a PR course compared to standard care in a randomised prospective study of patients with chronic obstructive pulmonary disease (COPD). This will be assessed, at 12 months following the initial course, in terms of disease specific health related quality of life as assessed by the dyspnoea domain of the chronic respiratory questionnaire, shuttle walk test, muscle strength, fat free mass, anxiety and depression scores, and exacerbation frequency. More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=7914
Ethics approval(s)	Cambridgeshire 1 REC, 16/06/2009, ref: 09/H0304/40
Health condition(s) or problem(s) studied	Topic: Respiratory, Primary Care Research Network for England; Subtopic: Not Assigned, Respiratory (all Subtopics); Disease: Respiratory, All Diseases
Intervention	A revision pulmonary rehabilitation session which lasts 2 hours and takes place every 3 months.
Intervention type	Other
Primary outcome measure(s)	Change from baseline in the dyspnoea domain of the Chronic Respiratory Questionnaire (CRQ)
Key secondary outcome measure(s)	Change in: 1. Other domains of CRQ 2. Endurance shuttle walk test 3. Muscle strength 4. Fat free mass 5. Body mass index 6. Quality Adjusted Life Years (QALY) gained (estimated from EQ-5D data) 7. Hospital anxiety and depression score (HADS) 8. Changes in medication and NHS Resource Utilisation including hospitalisations, health professional contact, medication and adverse events 9. Muscle strength and endurance (in a subgroup only)
Completion date	30/06/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	165
Key inclusion criteria	1. Male or female, aged more than 35 years 2. Physician labelled diagnosis of COPD, emphysema or chronic bronchitis 3. Ex or current smoker of more than 20 pack years 4. Forced expiratory volume in one second (FEV1) less than 80% of predicted 5. Patients may be taking long or short acting bronchodilators and/or inhaled or oral corticosteroids and/or theophyllines 6. Patients having attended at least 60% of the exercise sessions in the initial PR (This is an inclusion criterion for randomisation to receive maintenance PR or standard medical care but not entry into the study)
Key exclusion criteria	1. Significant cardiac or pulmonary disease other than COPD such that COPD is the minor contribution to the patients' symptoms 2. Myocardial infarction within the previous 6 months or unstable angina 3. Respiratory infection defined as cough, antibiotic use or purulent sputum within 4 weeks prior to randomisation 4. Severe or uncontrolled co-morbid disease, which is likely to affect the outcome of the study 5. Abnormalities in cognitive functioning that would limit the patient's ability to undertake the procedures required in the study 6. Unable to give written informed consent
Date of first enrolment	01/07/2009
Date of final enrolment	30/06/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of East Anglia

Norwich
NR4 7TJ
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	11/03/2015		Yes	No