Maintenance Schedules Following Pulmonary Rehabilitation

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

The Effects of Maintenance Schedules Following Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00925171
• Other study ID #: 2009RESP05
• Secondary ID: 09/H0304/40
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 19, 2009
• Last updated: August 3, 2011
• Start date: June 2009
• Est. completion date: June 2012

Study information

• Verified date: August 2011
• Source: University of East Anglia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 128
• Est. completion date: June 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Rehabilitation

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Norfolk and Norwich University Hospital	Norwich	Norfolk
United Kingdom	University of East Anglia	Norwich	Norfolk

Sponsors (1)

Lead Sponsor	Collaborator
University of East Anglia

Country where clinical trial is conducted

United Kingdom, 

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint will be change from baseline in the dyspnoea domain of the Chronic Respiratory Questionnaire (CRQ).		14 Months	No
Secondary	Endurance shuttle walk test		14 months	No
Secondary	Fat free mass		14 Months	No
Secondary	Body mass index		14 Months	No
Secondary	Quality Adjusted Life Years (QALY) gained (estimated from EQ-5D data)		14 Months	No
Secondary	Hospital anxiety and depression score (HADS)		14 Months	No
Secondary	Changes in medication and NHS Resource Utilisation including hospitalisations, health professional contact, medication and adverse events		14 Months	No
Secondary	Change in peripheral blood C-reactive protein, Tumour Necrosis Factor (TNF) alpha, Interleukin (IL) 6		14 Months	No