Long-term Impact of Pulmonary Rehabilitation

This study has suspended participant recruitment.
(Pending modifications)
Sponsor:
Collaborator:
ITS Pulmonary Rehabilitation Research Network
Information provided by:
Beaumont Hospital
ClinicalTrials.gov Identifier:
NCT00959855
First received: August 14, 2009
Last updated: May 25, 2010
Last verified: September 2009
  Purpose

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 Intervention
Chronic Obstructive Pulmonary Disease
Other: Pulmonary Rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Beaumont Hospital:

Primary Outcome Measures:
  • Quality of life score [ Time Frame: One year ] [ Designated as safety issue: No ]
    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:
  • Spiromtery [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Differences between the intervention group at 12 months .

  • Number of exacerbations of COPD. [ Time Frame: over one year ] [ Designated as safety issue: No ]
    The number of exacerbations of COPD will be compared between the control and the rehabilitation group.


Estimated Enrollment: 120
Study Start Date: September 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Pulmonary Rehabilitation
  • 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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00959855

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

No publications provided

Responsible Party: Professor Richard Costello, Beaumont Hospital
ClinicalTrials.gov Identifier: NCT00959855     History of Changes
Other Study ID Numbers: ITS-1-MCT
Study First Received: August 14, 2009
Last Updated: May 25, 2010
Health Authority: Ireland: Medical Ethics Research Committee

Keywords provided by Beaumont Hospital:
COPD
Pulmonary Rehabilitation
Inflammation
Oxidative Stress
Steps
Free Living Activities
Exacerbation

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

ClinicalTrials.gov processed this record on July 20, 2014