Maintenance Schedules Following Pulmonary Rehabilitation
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| ClinicalTrials.gov Identifier: NCT00925171 |
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Recruitment Status : Unknown
Verified August 2011 by University of East Anglia.
Recruitment status was: Active, not recruiting
First Posted : June 22, 2009
Last Update Posted : August 4, 2011
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Chronic obstructive pulmonary disease (COPD), a preventable and treatable condition, is a major healthcare problem with huge human and economic costs. It affects 3 million people, results in 1.4 million consultations, causes 30,000 deaths, and costs £800M per year in the UK. Considerable research expenditure is devoted to finding new and expensive interventions. However pulmonary rehabilitation (PR) is an available therapeutic option with good evidence of benefit for patients in terms of quality of life and daily functioning.
The primary objective of the study is to evaluate the effectiveness and cost effectiveness of the addition of a maintenance programme following pulmonary rehabilitation in patients with COPD when compared to standard care.
The secondary objective is to identify baseline characteristics that will predict improvement in pulmonary rehabilitation programmes and adherence to maintenance strategies. By measuring a series of demographic, clinical, physiological, psychological and biochemical parameters the researchers hope to be able to predict those patients who are likely to receive the greatest benefit from pulmonary rehabilitation.
An additional objective will be to prepare a detailed maintenance programme manual. This will be available to other centres providing pulmonary rehabilitation at the conclusion of the study
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Obstructive Pulmonary Disease Pulmonary Rehabilitation | Behavioral: Pulmonary Intervention | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 128 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | The Effects of Maintenance Schedules Following Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease |
| Study Start Date : | June 2009 |
| Estimated Primary Completion Date : | January 2012 |
| Estimated Study Completion Date : | June 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Pulmonary Rehabilitation Group
Intervention with exercise management
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Behavioral: Pulmonary Intervention
Maintenance programme of 2 hours duration, every 3 months. During the first hour patients will describe the extent to which they have been able to continue with their exercises at home on an individual basis and ways of enhancing adherence to this training will be discussed. Positive re-enforcement will be provided. Patients with suspected depression or social isolation will be referred to their GP for additional management. Patients will be advised on dyspnoea management strategies, especially controlled breathing combined with supervised activity exertion on activities relevant to their daily living. This will be followed by 1 hour of supervised strength and endurance training including walking, cycling, standing from sitting, arm exercises using dumbbells and step-ups. Patients will receive a written report on their progress by their physician and copied to their GP. This will be in addition to the standard advice given to the control group. |
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No Intervention: Control Group
Patients will receive the standard advice to undertake strength and endurance exercises at home and invitation to attend the Norwich Breath Easy Group Patients will be stratified according to whether the initial programme took place in the outpatient hospital or community setting |
- The primary endpoint will be change from baseline in the dyspnoea domain of the Chronic Respiratory Questionnaire (CRQ). [ Time Frame: 14 Months ]
- Endurance shuttle walk test [ Time Frame: 14 months ]
- Fat free mass [ Time Frame: 14 Months ]
- Body mass index [ Time Frame: 14 Months ]
- Quality Adjusted Life Years (QALY) gained (estimated from EQ-5D data) [ Time Frame: 14 Months ]
- Hospital anxiety and depression score (HADS) [ Time Frame: 14 Months ]
- Changes in medication and NHS Resource Utilisation including hospitalisations, health professional contact, medication and adverse events [ Time Frame: 14 Months ]
- Change in peripheral blood C-reactive protein, Tumour Necrosis Factor (TNF) alpha, Interleukin (IL) 6 [ Time Frame: 14 Months ]
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| Ages Eligible for Study: | 35 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00925171
| United Kingdom | |
| Norfolk and Norwich University Hospital | |
| Norwich, Norfolk, United Kingdom, NR4 7UY | |
| University of East Anglia | |
| Norwich, Norfolk, United Kingdom, NR47TJ | |
| Principal Investigator: | Andrew Wilson, MD MRCP (UK) | Clinical Senior Lecturer, University of East Anglia |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Andrew Wilson, University of East Anglia |
| ClinicalTrials.gov Identifier: | NCT00925171 |
| Other Study ID Numbers: |
2009RESP05 09/H0304/40 |
| First Posted: | June 22, 2009 Key Record Dates |
| Last Update Posted: | August 4, 2011 |
| Last Verified: | August 2011 |
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Chronic obstructive pulmonary disease Pulmonary rehabilitation Chronic Respiratory Questionnaire |
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Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |