Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00925171
Protocol/serial number
7914
Study information
Scientific title
The effects of maintenance schedules following pulmonary rehabilitation in patients with chronic obstructive pulmonary disease
Acronym
Study hypothesis
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
Cambridgeshire 1 REC, 16/06/2009, ref: 09/H0304/40
Study design
Randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
Change from baseline in the dyspnoea domain of the Chronic Respiratory Questionnaire (CRQ)
Secondary outcome measures
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)
Overall trial start date
01/07/2009
Overall trial end date
30/06/2012
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 165
Participant 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
Recruitment start date
01/07/2009
Recruitment end date
30/06/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
Sponsor information
Organisation
Norfolk and Norwich University Hospital NHS Foundation Trust (UK)
Sponsor details
Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25762226