Maintenance Schedules Following Pulmonary Rehabilitation
NCT ID: NCT00925171
Last Updated: 2011-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
128 participants
INTERVENTIONAL
2009-06-30
2012-06-30
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Pulmonary Rehabilitation Group
Intervention with exercise management
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.
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
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
35 Years
65 Years
ALL
No
Sponsors
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University of East Anglia
OTHER
Responsible Party
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University of East Anglia
Principal Investigators
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Andrew Wilson, MD MRCP (UK)
Role: PRINCIPAL_INVESTIGATOR
Clinical Senior Lecturer, University of East Anglia
Locations
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Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom
University of East Anglia
Norwich, Norfolk, United Kingdom
Countries
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References
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Other Identifiers
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09/H0304/40
Identifier Type: -
Identifier Source: secondary_id
2009RESP05
Identifier Type: -
Identifier Source: org_study_id
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