Maintenance schedules following pulmonary rehabilitation
| ISRCTN | ISRCTN68654480 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68654480 |
| ClinicalTrials.gov number | NCT00925171 |
| Secondary identifying numbers | 7914 |
- 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
Scientific
University of East Anglia
Biomedical Research Centre
Norwich
NR4 7TJ
United Kingdom
Study information
| Study design | Randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/07/2009 |
| Completion date | 30/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned sample size: 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
- England
- United Kingdom
Study participating centre
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
NR4 7TJ
United Kingdom
Sponsor information
Norfolk and Norwich University Hospital NHS Foundation Trust (UK)
University/education
University/education
Colney Lane
Colney
Norwich
NR4 7UY
England
United Kingdom
| Website | http://www.nnuh.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/01wspv808 |
Funders
Funder type
Government
National Institute for Health Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
