Long-term Impact of Pulmonary Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00959855
Recruitment Status : Suspended (Pending modifications)
First Posted : August 17, 2009
Last Update Posted : May 26, 2010
ITS Pulmonary Rehabilitation Research Network
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: Pulmonary Rehabilitation Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Long-term Evaluation of Activity and Health Status Pre and Post Pulmonary Rehabilitation - A Multi-Centred Trial.
Study Start Date : September 2009
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Other: Pulmonary 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.
Other Names:
  • Activity Armbands
  • Inspiratory Muscle Training
No Intervention: Pulmonary Rehabiliation
The control group will be assessed in the same time frame without participating in the rehabilitation class. They will avail of the next available class after the 12 month assessment.

Primary Outcome Measures :
  1. Quality of life score [ Time Frame: 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 :
  1. Spiromtery [ Time Frame: 12 months ]
    Differences between the intervention group at 12 months .

  2. Number of exacerbations of COPD. [ Time Frame: over one year ]
    The number of exacerbations of COPD will be compared between the control and the rehabilitation group.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00959855

Beaumont Hospital
Beaumont, Dublin, Ireland, 9
Sponsors and Collaborators
Beaumont Hospital
ITS Pulmonary Rehabilitation Research Network
Principal Investigator: Richard Costello, Professor Beaumont Hosptial

Responsible Party: Professor Richard Costello, Beaumont Hospital Identifier: NCT00959855     History of Changes
Other Study ID Numbers: ITS-1-MCT
First Posted: August 17, 2009    Key Record Dates
Last Update Posted: May 26, 2010
Last Verified: September 2009

Keywords provided by Beaumont Hospital:
Pulmonary Rehabilitation
Oxidative Stress
Free Living Activities

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