Condition category
Respiratory
Date applied
23/04/2010
Date assigned
23/04/2010
Last edited
10/06/2015
Prospective/Retrospective
Retrospectively 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

Dr Andrew M Wilson

ORCID ID

Contact details

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

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

http://www.nnuh.nhs.uk/

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

Publication citations

Additional files

Editorial Notes