Chronic Obstructive Pulmonary DiseaseNCT01530412
Long Term Evaluation of Activity Levels Post 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
Sustained improvement after pulmonary rehabilitation in activity levels as measured by an activity armband. Pulmonary rehabilitation is utilized to improve exercise capacity, quality of life and prognosis for patients who suffer from chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 35 years and older
- 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
- 65 participants
- Where
- 1 siteIreland
- Study dates
- Jun 2007to Jul 2010
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of COPD based on the GOLD staging of the disease
- Referred to pulmonary rehabilitation by a respiratory consultant or member of the COPD Team
- Modified Medical Research Council Score of 3 or above
- Ability to mobilize independently
- Motivated to exercise independently
Who cannot join
- No evidence of COPD on spirometry
- Acute exacerbation within the last 4-6 weeks
- Evidence of ischemic heart disease/acute changes on ECG
- Uncontrolled hypertension
- Insulin dependent diabetes mellitus
- Inability to exercise independently or musculoskeletal/neurological conditions which would prevent completion of the course
- Lung cancer previous attendance at pulmonary rehabilitation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Evaluation of Activity Levels Post Pulmonary Rehabilitation: 1 Year Follow-up
Sustained improvement after pulmonary rehabilitation in activity levels as measured by an activity armband.
Pulmonary rehabilitation is utilized to improve exercise capacity, quality of life and prognosis for patients who suffer from chronic obstructive pulmonary disease. There is also strong evidence that supports the use of pulmonary rehabilitation to decrease hospital admissions thereby reducing cost of care. Recent studies suggest that the significant benefits achieved through rehabilitation fade with time and that in order to improve activities of daily living; for example, average daily number of steps, programmes of longer duration are required.
The primary aim of this study is to identify objective sustained improved in activity levels using the SenseWear activity armband after a short-term pulmonary rehabilitation programme. Secondary aims are to determine antibiotic and steroid use pre and post rehabilitation.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is characterised by airflow limitation and by both systemic and airway inflammation. Together these features lead to decreased physical activity which in turn worsens the patient's dyspnoea. In patients with COPD, physical activity levels are low compared to healthy controls and indeed lower than in patients with other chronic conditions such as arthritis and diabetes. For patients with COPD, decreased physical activity and breathlessness are significant predictors of mortality and morbidity. By reversing deconditioning pulmonary rehabilitation using supervised and home exercise programs leads to increased exercise capacity and health quality of life scores. In order for the benefits of pulmonary rehabilitation to be sustained in the long-term it is essential that there is a change in the patient's physical activity in their home life. While practice guidelines recommend that there is transference of exercise to the home setting it is unknown if this happens in reality. Addressing whether there is an increase in physical activity at home after pulmonary rehabilitation is the focus of this study.
Physical activity can be measured in a number of ways, including direct observation, patient diaries and questionnaires, but one of the most successful are the performance based motion sensors such as pedometers and accelerometers. One such performance based motion sensor is the SenseWear accelerometer. The SenseWear has previously been used in patients with COPD, has been shown to be a reliable measure of physical activity performed in this population, other than those using rolators and it is objectively more accurate than questionnaires and diaries. The hypothesis of this study was that pulmonary rehabilitation leads to a sustained improvement in physical activity in patients with COPD. Physical activity was measured by the daily averaged activity recorded with a SenseWear armband at several time points in the year after a course of pulmonary rehabilitation.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Pulmonary Rehabilitation
- Keywords
- Quality of Life, Free-living activity, Exacerbation, Rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationOther
Patients undergo pulmonary rehabilitation for two hours twice a week for seven weeks. The first hour comprises of an individualized exercise programme and the second hour consists of an educational component. Patients are also required to undergo inspiratory muscle training five days a week for thirty minutes and exercise for an additional three days a week for thirty minutes.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients are randomized to the control group and are assessed pre rehabilitation and post rehabilitation after which they proceed to the intervention group. |
| Pulmonary Rehabilitation | Experimental | Patients undergo an active seven week pulmonary rehabilitation programme. Assessments occur pre rehabilitation, post rehabilitation, at three months and at one year. Receives: Other: Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained improvement in free-living activities, measured as the average daily METs
Using an accelerometer, which will be worn by patients for seven consecutive days at each time frame, daily average measurements of the number of steps per day, total energy expenditure and METs that will be broken down into sedentary, moderate and vigorous, plus sleep time and efficiency.
Measured: At the end of 1 year compared to baseline
Secondary outcomes (5)
Quality of Life
Two quality of life questionnaires will be utilized, 1) the St. Georges Disease Questionnaire; a disease specific questionnaire, 2)The generic EuroQol questionnaire
Measured: baseline will be compared to that at 1 year follow-up
The Incremental Shuttle Walk Test
This is a validated field exercise test used to prescribe exercise intensity and determine functional capacity
Measured: baseline will be compared to that at 1 year follow-up
The Modified Medical Research Council Scale
This questionnaire measures breathlessness on activity
Measured: baseline will be compared to that at 1 year follow-up
Pulmonary Function Tests
Measurements of forced expiratory volume in 1 second, Forced Vital Capacity, Inspiratory Capacity and peak inspiratory muscle pressure will all be measured
Measured: baseline will be compared to that at 1 year follow-up
Borg Score
A 10 point scale measurement of breathlessness
Measured: baseline will be compared to that at 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startJun 2007
- Primary completionJul 2010
- Study completionJul 2010
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaumont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Richard Costello, Beaumont Hospital
- Investigators
- Richard W Costello, Professor, Study chair, Beaumont HospitalBrenda M Deering, MSc Physio, Principal investigator, Beaumont HospitalClaire Egan, MSc Physio, Principal investigator, Beaumont HospitalNiamh M McCormack, MSc Nursing, Principal investigator, Beaumont Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530412
- Sponsor's protocol ID
- RCT-3-LTE
- Status last verified
- Feb 2012
- First submitted
- 18 Aug 2010
- Last updated
- 10 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Evaluation of Activity Levels Post Pulmonary Rehabilitation: 1 Year Follow-up
- ClinicalTrials.gov ID
- NCT01530412
- Acronym / sponsor ID
- RCT-3-LTE
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Quality of Life, Free-living activity, Exacerbation, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Beaumont HospitalUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 10 Feb 2012 (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.
Sustained improvement after pulmonary rehabilitation in activity levels as measured by an activity armband.
Pulmonary rehabilitation is utilized to improve exercise capacity, quality of life and prognosis for patients who suffer from chronic obstructive pulmonary disease. There is also strong evidence that supports the use of pulmonary rehabilitation to decrease hospital admissions thereby reducing cost of care. Recent studies suggest that the significant benefits achieved through rehabilitation fade with time and that in order to improve activities of daily living; for example, average daily number of steps, programmes of longer duration are required.
The primary aim of this study is to identify objective sustained improved in activity levels using the SenseWear activity armband after a short-term pulmonary rehabilitation programme. Secondary aims are to determine antibiotic and steroid use pre and post rehabilitation.
Detailed description
Chronic obstructive pulmonary disease (COPD) is characterised by airflow limitation and by both systemic and airway inflammation. Together these features lead to decreased physical activity which in turn worsens the patient's dyspnoea. In patients with COPD, physical activity levels are low compared to healthy controls and indeed lower than in patients with other chronic conditions such as arthritis and diabetes. For patients with COPD, decreased physical activity and breathlessness are significant predictors of mortality and morbidity. By reversing deconditioning pulmonary rehabilitation using supervised and home exercise programs leads to increased exercise capacity and health quality of life scores. In order for the benefits of pulmonary rehabilitation to be sustained in the long-term it is essential that there is a change in the patient's physical activity in their home life. While practice guidelines recommend that there is transference of exercise to the home setting it is unknown if this happens in reality. Addressing whether there is an increase in physical activity at home after pulmonary rehabilitation is the focus of this study.
Physical activity can be measured in a number of ways, including direct observation, patient diaries and questionnaires, but one of the most successful are the performance based motion sensors such as pedometers and accelerometers. One such performance based motion sensor is the SenseWear accelerometer. The SenseWear has previously been used in patients with COPD, has been shown to be a reliable measure of physical activity performed in this population, other than those using rolators and it is objectively more accurate than questionnaires and diaries. The hypothesis of this study was that pulmonary rehabilitation leads to a sustained improvement in physical activity in patients with COPD. Physical activity was measured by the daily averaged activity recorded with a SenseWear armband at several time points in the year after a course of pulmonary rehabilitation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients are randomized to the control group and are assessed pre rehabilitation and post rehabilitation after which they proceed to the intervention group. |
| Pulmonary Rehabilitation | Experimental | Other: Pulmonary RehabilitationPatients undergo an active seven week pulmonary rehabilitation programme. Assessments occur pre rehabilitation, post rehabilitation, at three months and at one year. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A diagnosis of COPD based on the GOLD staging of the disease
- Referred to pulmonary rehabilitation by a respiratory consultant or member of the COPD Team
- Modified Medical Research Council Score of 3 or above
- Ability to mobilize independently
- Motivated to exercise independently
Key exclusion criteria (7 listed)
- No evidence of COPD on spirometry
- Acute exacerbation within the last 4-6 weeks
- Evidence of ischemic heart disease/acute changes on ECG
- Uncontrolled hypertension
- Insulin dependent diabetes mellitus
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 RehabilitationPatients undergo pulmonary rehabilitation for two hours twice a week for seven weeks. The first hour comprises of an individualized exercise programme and the second hour consists of an educational component. Patients are also required to undergo inspiratory muscle training five days a week for thirty minutes and exercise for an additional three days a week for thirty minutes. | Other | Pulmonary Rehabilitation |
Primary outcome
Sustained improvement in free-living activities, measured as the average daily METs
Time frame: At the end of 1 year compared to baseline
Using an accelerometer, which will be worn by patients for seven consecutive days at each time frame, daily average measurements of the number of steps per day, total energy expenditure and METs that will be broken down into sedentary, moderate and vigorous, plus sleep time and efficiency.
5 secondary outcomes
Quality of Life
Time frame: baseline will be compared to that at 1 year follow-up
The Incremental Shuttle Walk Test
Time frame: baseline will be compared to that at 1 year follow-up
The Modified Medical Research Council Scale
Time frame: baseline will be compared to that at 1 year follow-up
Pulmonary Function Tests
Time frame: baseline will be compared to that at 1 year follow-up
Borg Score
Time frame: baseline will be compared to that at 1 year follow-up
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 10 Feb 2012.
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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 W Costello, Professor study chair
Beaumont Hospital
Brenda M Deering, MSc Physio principal investigator
Beaumont Hospital
Claire Egan, MSc Physio principal investigator
Beaumont Hospital
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 5 inclusion and 7 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 10 Feb 2012. 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?
Sustained improvement in free-living activities, measured as the average daily METs (time frame: At the end of 1 year compared to baseline). 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 10 Feb 2012.