Maintenance Schedules Following Pulmonary Rehabilitation

August 3, 2011 updated by: University of East Anglia

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospital
      • Norwich, Norfolk, United Kingdom, NR47TJ
        • University of East Anglia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pulmonary Rehabilitation Group
Intervention with exercise management
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint will be change from baseline in the dyspnoea domain of the Chronic Respiratory Questionnaire (CRQ).
Time Frame: 14 Months
14 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Endurance shuttle walk test
Time Frame: 14 months
14 months
Fat free mass
Time Frame: 14 Months
14 Months
Body mass index
Time Frame: 14 Months
14 Months
Quality Adjusted Life Years (QALY) gained (estimated from EQ-5D data)
Time Frame: 14 Months
14 Months
Hospital anxiety and depression score (HADS)
Time Frame: 14 Months
14 Months
Changes in medication and NHS Resource Utilisation including hospitalisations, health professional contact, medication and adverse events
Time Frame: 14 Months
14 Months
Change in peripheral blood C-reactive protein, Tumour Necrosis Factor (TNF) alpha, Interleukin (IL) 6
Time Frame: 14 Months
14 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of East Anglia

Investigators

  • Principal Investigator: Andrew Wilson, MD MRCP (UK), Clinical Senior Lecturer, University of East Anglia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

June 19, 2009

First Submitted That Met QC Criteria

June 19, 2009

First Posted (Estimate)

June 22, 2009

Study Record Updates

Last Update Posted (Estimate)

August 4, 2011

Last Update Submitted That Met QC Criteria

August 3, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009RESP05
  • 09/H0304/40

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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