Maintenance Schedules Following Pulmonary Rehabilitation

NCT00925171 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2011-08-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of East Anglia

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2012-01-31
Completion
2012-06-30

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00925171 on ClinicalTrials.gov