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Long-term Impact of Pulmonary Rehabilitation

Long-term Evaluation of Activity and Health Status Pre and Post Pulmonary Rehabilitation - A Multi-Centred Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00959855
Enrollment
120
Registered
2009-08-17
Start date
2009-09-30
Completion date
2011-09-30
Last updated
2019-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, Pulmonary Rehabilitation, Inflammation, Oxidative Stress, Steps, Free Living Activities, Exacerbation

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.

Interventions

OTHERPulmonary Rehabilitation

Sixteen, two hourly pulmonary rehabilitation sessions over an eight week period. The first hour will consist of an individualized exercise programme based on exercise field tests. The second hour will consist of an educational component. A home exercise programme of inspiratory muscle training (Threshold(R)IMT (respiratory muscle trainer re:HS730EU-001 single patient use) starting between 15% -30% of PiMax and progress weekly to 60% for 30 mins a day/ 5 dats a week with an inspiratory/expiratory ratio of 3:4. Patients will also be encouraged to walk or undertake an home exercise programme based on a Borg score of between 3 and 5 an additional 3 days a week.

Sponsors

ITS Pulmonary Rehabilitation Research Network
CollaboratorUNKNOWN
Beaumont Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of life scoreOne yearSt 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

MeasureTime frameDescription
Spiromtery12 monthsDifferences between the intervention group at 12 months .
Number of exacerbations of COPD.over one yearThe number of exacerbations of COPD will be compared between the control and the rehabilitation group.

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026