Chronic Obstructive Pulmonary DiseasesNCT02707770
The Role of Ambulatory Oxygen in Improving the Effectiveness of Pulmonary Rehabilitation for COPD Patients
A study testing Pulmonary Rehabilitation in people with Chronic Obstructive Pulmonary Diseases, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
Pulmonary rehabilitation (PR) is an exercise program tailored for patients with chronic lung disease that is a core part of the management of patients with Chronic Obstructive Pulmonary Disease (COPD). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Diseases
- What is being tested?
- Pulmonary Rehabilitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Apr 2016to 30 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- Fulfil the clinical criteria for Pulmonary Rehabilitation (PR)
- Demonstrate exercise-induced desaturation (defined as a fall in SaO2 ≥4% to at least <90%, or any fall to a SaO2 <90%) and demonstrate positive improvement with use of ambulatory oxygen as per the British Thoracic Society 2015 Oxygen Guidelines
Who cannot join
- Use of long term oxygen therapy
- Unable to provide informed consent
- Significant respiratory disease other than COPD
- Any patient needing more than 6 litres per minute oxygen to correct desaturation
- Severe desaturation: SaO2 < 80% during 6 Minute Walk Test
- Any absolute contraindication to Pulmonary Rehabilitation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Ambulatory Oxygen in Improving the Effectiveness of Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Diseases Patients
Pulmonary rehabilitation (PR) is an exercise program tailored for patients with chronic lung disease that is a core part of the management of patients with Chronic Obstructive Pulmonary Disease (COPD). Many COPD patients develop low oxygen levels (desaturation) during exercise and this is often discovered when they are being evaluated for PR. Current practice is to administer oxygen to COPD patients with exercise-induced desaturation, but this is based on very limited evidence. This limited evidence relates to a short-term increase in exercise capacity and it is not known if this translates into longer term increases in activity or whether providing these patients with oxygen improves outcomes after PR.
In addition it is not known if patients given ambulatory oxygen continue to use it after completing PR. Evidence for a beneficial effect of oxygen would provide a more solid evidence base for its use. Conversely demonstration of no effect would allow reassessment of the use of oxygen and whether the costs are justified. Therefore the aims of this study are to assess the effects of oxygen on outcomes from PR and assess the usage of ambulatory oxygen following completion of PR.
Read the detailed description
The study will be a randomised, single-blinded study comparing oxygen with air in Chronic Obstructive Pulmonary Disease (COPD) patients undergoing Pulmonary Rehabilitation (PR).
The study subjects will be patients with a confirmed diagnosis of COPD who have been accepted for PR and who are not hypoxemic at rest, but have exercise-induced desaturation (defined as a fall in oxygen saturations (SaO2) ≥4% to at least <90%, or any fall to a SaO2 <90%) and demonstrate positive improvement with use of ambulatory oxygen as per the British Thoracic Society 2015 Oxygen guidelines. It is standard practice for patients to have this assessment prior to commencing PR and as part of the assessment the flow rate required to increase the SaO2 to ≥90% during exercise will be determined. Patients will be recruited from PR programs at imperial college health care trust hospitals.
The subjects will be randomised to receive either oxygen at the flow rate determined at the initial assessment to a maximum flow rate of 6 litres per minute, or room air. The subjects will then undergo a standard program of PR over 6 - 8 weeks and then undergo reassessment. 20 patients are required in each group to detect a 30% effect size on the 6 minute walk test (6MWT) with 80% power at the 5% significance level and 29 patients in each group to detect a 25% effect with 80% power. Therefore a minimum of 20 patients per group will be included.
Baseline assessments prior to commencing PR will include symptom and quality of life assessments including Borg scale for assessment of breathlessness, Chronic Respiratory Questionnaire (CRQ), COPD Assessment Tool (CAT) and the Hospital Anxiety and Depression score (HAD). A 6 minute walk test (6MWT) will be carried out as this is a widely used and well validated tool to measure exercise capacity. A handheld dynamometer will be used to obtain more detailed measures of quadriceps muscle strength. In addition we will measure activity at home during and after PR using pedometers as this has never been investigated previously.These are simple devices that can be attached to patients and count the numbers of steps during a day and therefore provide an estimate of activity in the home environment. A yamax Digi-walker SW-200 pedometer will be used to count the number of steps taken per day. Patients will be instructed to wear the device on left side of the body all the time, except when sleeping or showering. Pedometer placement was standardised by placing it on the belt or waistband, in the midline of the thigh, consistent with the manufacturers recommendation and with other studies conducted previously. Patients will be record daily step counts on daily diary cards until their final follow up.
The measures of exercise capacity at the follow up assessment will be carried out off oxygen and will be carried out by an observer blinded as to whether they received oxygen or not during PR. All patients will be provided with ambulatory oxygen for domiciliary use after completing PR.
The hypothesis is that use of oxygen in selected patients improves exercise capacity during PR. The measurable aims will be exercise capacity and on-going usage of oxygen in this patient group.
Primary Objective
Assess the effects of ambulatory oxygen on outcomes from Pulmonary Rehabilitation
Secondary Objectives
- Assess the proportion of patients that wish to continue to use ambulatory oxygen.
- Assess the usage of ambulatory oxygen following completion of Pulmonary Rehabilitation
- Assess whether initiation of ambulatory oxygen before or after PR has any influence on adherence to usage at 8 and 12 weeks.
- Conditions
- Chronic Obstructive Pulmonary Diseases
- Being tested
- Pulmonary Rehabilitation
- Keywords
- COPD, pulmonary rehabilitation, ambulatory oxygen therapy
- 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
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory oxygen | Experimental | Patient will use ambulatory oxygen during pulmonary rehabilitation programme (flow rate determined at the initial assessment to a maximum flow rate of 6 litres per minute) Receives: Other: Pulmonary Rehabilitation |
| Room air | Placebo comparator | Patient will breath on room air during pulmonary rehabilitation programme Receives: Other: Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Exercise Capacity
6 Minute Walk Test (6MWT)- Distance in meters
Measured: 0, 8weeks
Secondary outcomes (6)
Number of Participants Reporting a Change in the Quality of Life
Chronic Respiratory Questionnaire(CRQ)- Number of Participants achieving minimal clinically important difference (MCID) in CRQ compared between baseline and follow up assessment.
Measured: 0,8weeks
Number of Participants Reporting a Change in Anxiety Score
Hospital anxiety and depression score- Anxiety component (HADS-A)-Numbers of participants achieving Minimal clinically important difference in HADS-A compared between baseline and follow up assessment.
Measured: 0,8weeks
Number of Participants Reporting Change in Depression Score
Hospital anxiety and depression score- Depression component (HADS-D)-Numbers of participants achieving Minimal clinically important difference in HADS-D compared between baseline and follow up assessment.
Measured: 0,8weeks
Number of Participants Reporting Change in Chronic Obstructive Pulmonary Diseases Assessment Test (CAT)
Chronic Obstructive Pulmonary diseases Assessment Test (CAT score)-Numbers of participants achieving Minimal clinically important difference in CAT score compared between baseline and follow up assessment.
Measured: 0,8weeks
Number of Patients Reporting Change in Physical Activity
Pedometer- Number of step counts
Measured: 8 weeks
Number of Participants With Change in Quadriceps Muscle Strength
Handheld Muscle testing- Number of participants achieving Minimal clinical important difference in quadriceps muscle strength compared between baseline and follow up assessment
Measured: 0,8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study start14 Apr 2016
- Primary completion19 Jun 2017
- Study completion30 Dec 2017
Why it stopped: Funding for the study finished before anticipated participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Vijayaragavan Padmanaban, MPT, Principal investigator, Imperial healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707770
- Sponsor's protocol ID
- 15SM3060
- Status last verified
- Mar 2021
- First submitted
- 23 Feb 2016
- Last updated
- 30 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Ambulatory Oxygen in Improving the Effectiveness of Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Diseases Patients
- ClinicalTrials.gov ID
- NCT02707770
- Acronym / sponsor ID
- 15SM3060
- Conditions
- Chronic Obstructive Pulmonary Diseases
- Keywords
- COPD, pulmonary rehabilitation, ambulatory oxygen therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding for the study finished before anticipated participants enrolled
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 14 Apr 2016 (actual)
- Primary completion
- 19 Jun 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 14 Mar 2016 (estimated)
- Results
- Posted 30 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pulmonary rehabilitation (PR) is an exercise program tailored for patients with chronic lung disease that is a core part of the management of patients with Chronic Obstructive Pulmonary Disease (COPD). Many COPD patients develop low oxygen levels (desaturation) during exercise and this is often discovered when they are being evaluated for PR. Current practice is to administer oxygen to COPD patients with exercise-induced desaturation, but this is based on very limited evidence. This limited evidence relates to a short-term increase in exercise capacity and it is not known if this translates into longer term increases in activity or whether providing these patients with oxygen improves outcomes after PR.
In addition it is not known if patients given ambulatory oxygen continue to use it after completing PR. Evidence for a beneficial effect of oxygen would provide a more solid evidence base for its use. Conversely demonstration of no effect would allow reassessment of the use of oxygen and whether the costs are justified. Therefore the aims of this study are to assess the effects of oxygen on outcomes from PR and assess the usage of ambulatory oxygen following completion of PR.
Detailed description
The study will be a randomised, single-blinded study comparing oxygen with air in Chronic Obstructive Pulmonary Disease (COPD) patients undergoing Pulmonary Rehabilitation (PR).
The study subjects will be patients with a confirmed diagnosis of COPD who have been accepted for PR and who are not hypoxemic at rest, but have exercise-induced desaturation (defined as a fall in oxygen saturations (SaO2) ≥4% to at least <90%, or any fall to a SaO2 <90%) and demonstrate positive improvement with use of ambulatory oxygen as per the British Thoracic Society 2015 Oxygen guidelines. It is standard practice for patients to have this assessment prior to commencing PR and as part of the assessment the flow rate required to increase the SaO2 to ≥90% during exercise will be determined. Patients will be recruited from PR programs at imperial college health care trust hospitals.
The subjects will be randomised to receive either oxygen at the flow rate determined at the initial assessment to a maximum flow rate of 6 litres per minute, or room air. The subjects will then undergo a standard program of PR over 6 - 8 weeks and then undergo reassessment. 20 patients are required in each group to detect a 30% effect size on the 6 minute walk test (6MWT) with 80% power at the 5% significance level and 29 patients in each group to detect a 25% effect with 80% power. Therefore a minimum of 20 patients per group will be included.
Baseline assessments prior to commencing PR will include symptom and quality of life assessments including Borg scale for assessment of breathlessness, Chronic Respiratory Questionnaire (CRQ), COPD Assessment Tool (CAT) and the Hospital Anxiety and Depression score (HAD). A 6 minute walk test (6MWT) will be carried out as this is a widely used and well validated tool to measure exercise capacity. A handheld dynamometer will be used to obtain more detailed measures of quadriceps muscle strength. In addition we will measure activity at home during and after PR using pedometers as this has never been investigated previously.These are simple devices that can be attached to patients and count the numbers of steps during a day and therefore provide an estimate of activity in the home environment. A yamax Digi-walker SW-200 pedometer will be used to count the number of steps taken per day. Patients will be instructed to wear the device on left side of the body all the time, except when sleeping or showering. Pedometer placement was standardised by placing it on the belt or waistband, in the midline of the thigh, consistent with the manufacturers recommendation and with other studies conducted previously. Patients will be record daily step counts on daily diary cards until their final follow up.
The measures of exercise capacity at the follow up assessment will be carried out off oxygen and will be carried out by an observer blinded as to whether they received oxygen or not during PR. All patients will be provided with ambulatory oxygen for domiciliary use after completing PR.
The hypothesis is that use of oxygen in selected patients improves exercise capacity during PR. The measurable aims will be exercise capacity and on-going usage of oxygen in this patient group.
Primary Objective
Assess the effects of ambulatory oxygen on outcomes from Pulmonary Rehabilitation
Secondary Objectives
- Assess the proportion of patients that wish to continue to use ambulatory oxygen.
- Assess the usage of ambulatory oxygen following completion of Pulmonary Rehabilitation
- Assess whether initiation of ambulatory oxygen before or after PR has any influence on adherence to usage at 8 and 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambulatory oxygen | Experimental | Other: Pulmonary RehabilitationPatient will use ambulatory oxygen during pulmonary rehabilitation programme (flow rate determined at the initial assessment to a maximum flow rate of 6 litres per minute) |
| Room air | Placebo comparator | Other: Pulmonary RehabilitationPatient will breath on room air during pulmonary rehabilitation programme |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- A confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- Fulfil the clinical criteria for Pulmonary Rehabilitation (PR)
- Demonstrate exercise-induced desaturation (defined as a fall in SaO2 ≥4% to at least <90%, or any fall to a SaO2 <90%) and demonstrate positive improvement with use of ambulatory oxygen as per the British Thoracic Society 2015 Oxygen Guidelines
Key exclusion criteria (6 listed)
- Use of long term oxygen therapy
- Unable to provide informed consent
- Significant respiratory disease other than COPD
- Any patient needing more than 6 litres per minute oxygen to correct desaturation
- Severe desaturation: SaO2 < 80% during 6 Minute Walk Test
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 Rehabilitation | Other | Ambulatory oxygen, Room air |
Primary outcome
Change in Functional Exercise Capacity
Time frame: 0, 8weeks
6 Minute Walk Test (6MWT)- Distance in meters
6 secondary outcomes
Number of Participants Reporting a Change in the Quality of Life
Time frame: 0,8weeks
Number of Participants Reporting a Change in Anxiety Score
Time frame: 0,8weeks
Number of Participants Reporting Change in Depression Score
Time frame: 0,8weeks
Number of Participants Reporting Change in Chronic Obstructive Pulmonary Diseases Assessment Test (CAT)
Time frame: 0,8weeks
Number of Patients Reporting Change in Physical Activity
Time frame: 8 weeks
Number of Participants With Change in Quadriceps Muscle Strength
Time frame: 0,8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Vijayaragavan Padmanaban, MPT principal investigator
Imperial healthcare NHS Trust
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 Diseases, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 30 Mar 2021. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 30 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Functional Exercise Capacity (time frame: 0, 8weeks). 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 30 Mar 2021.