The Effects of Maintenance Schedules Following Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
35 Years
65 Years
Both
Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation
Trial Information
The Effects of Maintenance Schedules Following Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
This will be a randomised, controlled, parallel study of a maintenance pulmonary
rehabilitation (PR) programme in patients with chronic obstructive pulmonary disease (COPD).
Following successful completion of a PR programme in Norwich(see below) patients will be
randomised to receive maintenance PR or standard medical care.
Prior to enrolment in the PR programme, patients will undergo standard baseline assessments,
after providing informed consent. These will include a medical examination, demographic
details, past medical history, spirometry, an incremental shuttle walk test (ISWT) to
determine a predicted maximum oxygen consumption, an endurance shuttle walk test (ESWT) at
85% of predicted maximum oxygen consumption (V02), chronic respiratory questionnaire (CRQ),
EuroQol (EQ5D), hospital anxiety and depression score (HADS), serum interleukin(IL)-6 and
C-reactive protein (CRP), body mass index (BMI), skinfold thickness and muscle strength.
At the end of PR and twelve months following PR patients will undergo medical examination,
ESWT at 85% of predicted maximum VO2, CRQ, EQ5D, HADS, serum interleukin(IL)-6 and CRP, BMI,
skinfold thickness and muscle strength and an assessment of activity in the preceding month.
At 3 months, 6 months and 9 months following PR patients will complete the CRQ and a
questionnaire to assess activity in the preceding month. These will be undertaken by postal
questionnaire.
Baseline socioeconomic and costs questionnaire will be completed at entry to the PR and
follow-up cost questionnaires will be completed following PR and after 3, 6, 9 and 12
months. Patients will be given a diary card on which to record NHS contacts, prescriptions
etc at all visits.
The 3, 6 and 9-month questionnaires will be collected by post.
Inclusion Criteria:
- Male or female, aged more than 35 years
- Physician labelled diagnosis of COPD, emphysema or chronic bronchitis
- Ex or current smoker of more than 20 pack years
- FEV1 less than 80% of predicted
- Patients may be taking long or short acting bronchodilators and/or inhaled or oral
corticosteroids and/or theophyllines.
- Patients having attended at least 60% of the exercise sessions in the initial PR(22)*
* This is an inclusion criterion for randomisation to receive maintenance PR or
standard medical care but not entry into the study
Exclusion Criteria:
- Significant cardiac or pulmonary disease other than COPD such that COPD is the minor
contribution to the patients' symptoms.
- Myocardial infarction within the previous 6 months or unstable angina
- Respiratory infection defined as cough, antibiotic use or purulent sputum within 4
weeks prior to randomisation.
- Severe or uncontrolled co-morbid disease, which is likely to affect the outcome of
the study.
- Abnormalities in cognitive functioning that would limit the patient's ability to
undertake the procedures required in the study.
- Unable to give written informed consent.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
The primary endpoint will be change from baseline in the dyspnoea domain of the Chronic Respiratory Questionnaire (CRQ).
Outcome Time Frame:
14 Months
Safety Issue:
No
Principal Investigator
Andrew Wilson, MD MRCP (UK)
Investigator Role:
Principal Investigator
Investigator Affiliation:
Clinical Senior Lecturer, University of East Anglia
Authority:
United Kingdom: National Health Service
Study ID:
2009RESP05
NCT ID:
NCT00925171
Start Date:
June 2009
Completion Date:
June 2012
Related Keywords:
- Chronic Obstructive Pulmonary Disease
- Pulmonary Rehabilitation
- Chronic obstructive pulmonary disease
- Pulmonary rehabilitation
- Chronic Respiratory Questionnaire
- Lung Diseases
- Respiration Disorders
- Pulmonary Disease, Chronic Obstructive
- Lung Diseases, Obstructive
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