Long-term Impact of Pulmonary Rehabilitation

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Pulmonary Rehabilitation

• Registration Number: NCT00959855
• Lead Sponsor: Beaumont Hospital

Brief Summary

This study has been designed to capture a large group of patients who undergo pulmonary rehabilitation and map their progression over a 5 year time-frame.

The outcome measures have been chosen to capture physiological, functional capacity, free-living activities plus admission and exacerbation rates thereby enhancing our understanding of the potential effects exercise and self management techniques may have on the disease progression.

Pulmonary rehabilitation has not been shown to reduce inflammation; therefore, unlike acute exacerbation's where a decrease in inflammation indicates recovery, the exact mechanisms responsible for improvement during pulmonary rehabilitation are as yet unknown.

Detailed Description

The benefits of pulmonary rehabilitation are well documented elsewhere, however, the exact mechanisms responsible for these significant improvements and alteration of the disease progression are unexplained. Also unexplained is the apparent lack of carry over of functional capacity into free-living activities as measured by activity monitors.

There are no reported effects on decreasing level of inflammatory cytokines or C-reactive protein (CRP) post rehabilitation, however, a training response to reactive oxidative stress (ROS) after a moderate intensity pulmonary rehabilitation programme has been reported. As oxidative stress is a catalyst to inflammation, a training response to exercise induced ROS in patients with COPD may also have a secondary effect of modifying inflammation in the stable COPD patient thereby improving patient outcomes.

No studies to-date have combined free-living activities, biomarkers and standard outcome measures in patient's pre and post pulmonary rehabilitation or follow-up patients over a five year period.

Subjects referred to pulmonary rehabilitation who fulfil the GOLD criteria for COPD will be recruited on a rolling basis and randomly allocated to one of two groups. Group 1 (Control), Group 2 (Intervention).

It is a multi-centred, randomised controlled trial using the above convenience sample of patients referred to pulmonary rehabilitation who meet the inclusion/exclusion criteria.

Study Timeline

• Study First Submitted: 2009-08-14
• Study First Submitted QC: 2009-08-14
• Study First Posted: 2009-08-17
• Study Start: 2009-09
• Primary Completion: 2010-09
• Study Completion: 2011-09
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. A diagnosis of COPD based on the GOLD staging of the Disease
2. MMRC score of 3 or above
3. Ability to mobilize independently
4. Willing to comply with the home exercise and inspiratory muscle training programmes
5. Willing to wear the SenseWare Armband
6. Optimal medical management
7. No adverse effects to exercise testing
8. Patient's awaiting lung transplant

Exclusion Criteria

1. Evidence of ischemic heart disease/acute changes on ECG
2. Uncontrolled hypertension
3. Insulin dependent diabetes mellitus
4. Uncontrolled CCF / idiopathic cardiomyopathy
5. Reversible Asthma
6. A diagnosis of lung cancer/TB/recent pneumothorax/PE or pneumonia
7. Any musculoskeletal/neurological condition which would render the patient incapable of completing the course
8. Exacerbation of COPD within 4 weeks of program
9. Poor cognitive status
10. Previous attendance at a pulmonary rehabilitation program

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulmonary Rehabilitation	Pulmonary Rehabilitation	Pulmonary rehabilitation classes based on the British Thoracic Society guidelines will be undertaken for two hours for 16 sessions within an eight week period.

Primary Outcome Measures

Name	Time	Method
Quality of life score	One year	St George's quality of life score at the end of one year will be compared between those who underwent rehabilitaion and those who were in the control non intervention group.

Secondary Outcome Measures

Name	Time	Method
Number of exacerbations of COPD.	over one year	The number of exacerbations of COPD will be compared between the control and the rehabilitation group.
Spiromtery	12 months	Differences between the intervention group at 12 months .

Trial Locations

Locations (1)

Beaumont Hospital; 🇮🇪 Beaumont, Dublin, Ireland