Maintenance Schedules Following Pulmonary Rehabilitation

NCT00925171 | Unknown Phase 2

• 2 other identifiers: 2009RESP0509/H0304/40
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Chronic Obstructive Pulmonary Disease; Pulmonary Rehabilitation

Keywords

Chronic obstructive pulmonary disease; Pulmonary rehabilitation; Chronic Respiratory Questionnaire

Outcome Measures

Primary Outcomes (1)

• The primary endpoint will be change from baseline in the dyspnoea domain of the Chronic Respiratory Questionnaire (CRQ).

  14 Months

Secondary Outcomes (7)

• Endurance shuttle walk test

  14 months

• Fat free mass

  14 Months

• Body mass index

  14 Months

• Quality Adjusted Life Years (QALY) gained (estimated from EQ-5D data)

  14 Months

• Hospital anxiety and depression score (HADS)

  14 Months

Study Arms (2)

Pulmonary Rehabilitation Group

EXPERIMENTAL

Intervention with exercise management

Behavioral: Pulmonary Intervention

Control Group

NO INTERVENTION

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

Interventions

Pulmonary Intervention BEHAVIORAL

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.

Pulmonary Rehabilitation Group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of East Anglia: lead

Study Sites (2)

Norfolk and Norwich University Hospital

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

University of East Anglia

Norwich, Norfolk, NR47TJ, United Kingdom

Location

Related Publications (36)

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  PMID: 25762226 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Wilson, MD MRCP (UK)

  Clinical Senior Lecturer, University of East Anglia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 19, 2009
• First Posted: June 22, 2009
• Study Start: June 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 4, 2011

Record last verified: 2011-08

Locations

GB (2)