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

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

Study information

Study designRandomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThe effects of maintenance schedules following pulmonary rehabilitation in patients with chronic obstructive pulmonary disease
Study objectivesThe 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) studiedTopic: Respiratory, Primary Care Research Network for England; Subtopic: Not Assigned, Respiratory (all Subtopics); Disease: Respiratory, All Diseases
InterventionA revision pulmonary rehabilitation session which lasts 2 hours and takes place every 3 months.
Intervention typeOther
Primary outcome measureChange from baseline in the dyspnoea domain of the Chronic Respiratory Questionnaire (CRQ)
Secondary outcome measuresChange 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 date01/07/2009
Completion date30/06/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned sample size: 165
Key inclusion criteria1. 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 criteria1. 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 enrolment01/07/2009
Date of final enrolment30/06/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of East Anglia
Norwich
NR4 7TJ
United Kingdom

Sponsor information

Norfolk and Norwich University Hospital NHS Foundation Trust (UK)
University/education

Colney Lane
Colney
Norwich
NR4 7UY
England
United Kingdom

Website http://www.nnuh.nhs.uk/
ROR logo "ROR" https://ror.org/01wspv808

Funders

Funder type

Government

National Institute for Health Research
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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