Maintenance Schedules Following Pulmonary Rehabilitation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of East Anglia.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of East Anglia
ClinicalTrials.gov Identifier:
NCT00925171
First received: June 19, 2009
Last updated: August 3, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Pulmonary Rehabilitation
Behavioral: Pulmonary Intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Effects of Maintenance Schedules Following Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by University of East Anglia:

Primary Outcome Measures:
  • The primary endpoint will be change from baseline in the dyspnoea domain of the Chronic Respiratory Questionnaire (CRQ). [ Time Frame: 14 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endurance shuttle walk test [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Fat free mass [ Time Frame: 14 Months ] [ Designated as safety issue: No ]
  • Body mass index [ Time Frame: 14 Months ] [ Designated as safety issue: No ]
  • Quality Adjusted Life Years (QALY) gained (estimated from EQ-5D data) [ Time Frame: 14 Months ] [ Designated as safety issue: No ]
  • Hospital anxiety and depression score (HADS) [ Time Frame: 14 Months ] [ Designated as safety issue: No ]
  • Changes in medication and NHS Resource Utilisation including hospitalisations, health professional contact, medication and adverse events [ Time Frame: 14 Months ] [ Designated as safety issue: No ]
  • Change in peripheral blood C-reactive protein, Tumour Necrosis Factor (TNF) alpha, Interleukin (IL) 6 [ Time Frame: 14 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: June 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925171

Locations
United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom, NR4 7UY
University of East Anglia
Norwich, Norfolk, United Kingdom, NR47TJ
Sponsors and Collaborators
University of East Anglia
Investigators
Principal Investigator: Andrew Wilson, MD MRCP (UK) Clinical Senior Lecturer, University of East Anglia
  More Information

Publications:

Responsible Party: Andrew Wilson, University of East Anglia
ClinicalTrials.gov Identifier: NCT00925171     History of Changes
Other Study ID Numbers: 2009RESP05, 09/H0304/40
Study First Received: June 19, 2009
Last Updated: August 3, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by University of East Anglia:
Chronic obstructive pulmonary disease
Pulmonary rehabilitation
Chronic Respiratory Questionnaire

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014