Chronic Obstructive Pulmonary DiseaseNCT00959855
Long-term Impact of Pulmonary Rehabilitation
A study testing Pulmonary Rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Beaumont Hospital at 1 site in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Pulmonary Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIreland
- Study dates
- Sep 2009to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A diagnosis of COPD based on the GOLD staging of the Disease
- MMRC score of 3 or above
- Ability to mobilize independently
- Willing to comply with the home exercise and inspiratory muscle training programmes
- Willing to wear the SenseWare Armband
- Optimal medical management
- No adverse effects to exercise testing
- Patient's awaiting lung transplant
Who cannot join
- Evidence of ischemic heart disease/acute changes on ECG
- Uncontrolled hypertension
- Insulin dependent diabetes mellitus
- Uncontrolled CCF / idiopathic cardiomyopathy
- Reversible Asthma
- A diagnosis of lung cancer/TB/recent pneumothorax/PE or pneumonia
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- Any musculoskeletal/neurological condition which would render the patient incapable of completing the course
- Exacerbation of COPD within 4 weeks of program
- Poor cognitive status
- Previous attendance at a pulmonary rehabilitation program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Evaluation of Activity and Health Status Pre and Post Pulmonary Rehabilitation - A Multi-Centred Trial.
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Pulmonary Rehabilitation
- Keywords
- COPD, Pulmonary Rehabilitation, Inflammation, Oxidative Stress, Steps, Free Living Activities, Exacerbation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationOther
Also called Activity Armbands, Inspiratory Muscle Training
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.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Rehabilitation | Experimental | Pulmonary rehabilitation classes based on the British Thoracic Society guidelines will be undertaken for two hours for 16 sessions within an eight week period. Receives: Other: Pulmonary Rehabilitation |
| Pulmonary Rehabiliation | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life score
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.
Measured: One year
Secondary outcomes (2)
Spiromtery
Differences between the intervention group at 12 months .
Measured: 12 months
Number of exacerbations of COPD.
The number of exacerbations of COPD will be compared between the control and the rehabilitation group.
Measured: over one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaumont Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ITS Pulmonary Rehabilitation Research Network
- Responsible party
- Principal investigator, Professor Richard Costello, Beaumont Hospital
- Investigators
- Richard Costello, Professor, Principal investigator, Beaumont Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959855
- Sponsor's protocol ID
- ITS-1-MCT
- Status last verified
- Jul 2019
- First submitted
- 14 Aug 2009
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Evaluation of Activity and Health Status Pre and Post Pulmonary Rehabilitation - A Multi-Centred Trial.
- ClinicalTrials.gov ID
- NCT00959855
- Acronym / sponsor ID
- ITS-1-MCT
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Pulmonary Rehabilitation, Inflammation, Oxidative Stress, Steps, Free Living Activities, Exacerbation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Beaumont HospitalUniversity, hospital or other
- Collaborators
- ITS Pulmonary Rehabilitation Research Network
- Study start
- Sep 2009 (actual)
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 17 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Rehabilitation | Experimental | Other: Pulmonary RehabilitationPulmonary rehabilitation classes based on the British Thoracic Society guidelines will be undertaken for two hours for 16 sessions within an eight week period. |
| Pulmonary Rehabiliation | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- A diagnosis of COPD based on the GOLD staging of the Disease
- MMRC score of 3 or above
- Ability to mobilize independently
- Willing to comply with the home exercise and inspiratory muscle training programmes
- Willing to wear the SenseWare Armband
Key exclusion criteria (10 listed)
- Evidence of ischemic heart disease/acute changes on ECG
- Uncontrolled hypertension
- Insulin dependent diabetes mellitus
- Uncontrolled CCF / idiopathic cardiomyopathy
- Reversible Asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary RehabilitationAlso: Activity Armbands, Inspiratory Muscle TrainingSixteen, 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 | Pulmonary Rehabilitation |
Primary outcome
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.
2 secondary outcomes
Spiromtery
Time frame: 12 months
Number of exacerbations of COPD.
Time frame: over one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Costello, Professor principal investigator
Beaumont Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Beaumont Hospital at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life score (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.