Chronic Obstructive Pulmonary Disease (COPD)LIVELYNCT02161393
Physical Activity Versus Pulmonary Rehabilitation in COPD
A study testing Physical Activity Intervention and Pulmonary Rehabilitation Programme in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Ulster at 2 sites in United Kingdom.
Trial summary
The primary aim of this study is to assess the feasibility of conducting a trial to investigate the effectiveness of a physical activity intervention (physical activity consultation and a pedometer-based walking programme) versus pulmonary rehabilitation in improving physical activity in COPD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Physical Activity Intervention and Pulmonary Rehabilitation Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Feb 2014to 19 Jan 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The Patient must be referred to pulmonary rehabilitation.
- The Patient must have a Primary diagnosis of COPD
- The Patient must have a good understanding of written English (as reported by the individual patient)
- The Patient must be in a stable phase (not on antibiotics at the time of assessment with the ISWT), and deemed clinically stable by the clinical pulmonary rehabilitation team.
Who cannot join
- The inability to safely take part in a walking programme or pulmonary rehabilitation (e.g. unstable angina, neurological, spinal or skeletal dysfunction affecting ability to exercise)
- The inability to comprehend or follow instructions (e.g. dementia).
- Clinically unstable (Pulmonary exacerbation or any change in symptoms and medication in the last 4 weeks)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Belfast Health and Social Care Trust
Belfast, Co Antrim, BT9 7AB
Western Health and Social Care Trust
Enniskillen
About this study
Official title: PhysicaL actIvity interVention vErsus puLmonarY Rehabilitation in COPD: The LIVELY COPD Project.
The primary aim of this study is to assess the feasibility of conducting a trial to investigate the effectiveness of a physical activity intervention (physical activity consultation and a pedometer-based walking programme) versus pulmonary rehabilitation in improving physical activity in COPD.
Objectives are:
Read more
(i) to assess the feasibility (patient recruitment, adherence, drop-outs and adverse events) of delivering a physical activity intervention in the COPD patient population versus pulmonary rehabilitation; (ii) to explore users perceptions relating to satisfaction and benefits of a physical activity intervention versus pulmonary rehabilitation; (iii) to investigate between and within group change in physical activity, exercise capacity, quality of life, self-efficacy and changes in the transtheoretical model with the physical activity intervention versus pulmonary rehabilitation; and (iv) to examine the cost of delivering a physical activity intervention versus pulmonary rehabilitation for patients with COPD.
The hypothesis for this study is that it will be feasible to conduct a trial that will investigate the effectiveness of a physical activity intervention (physical activity consultation and a pedometer-based walking programme) compared to pulmonary rehabilitation for improving physical activity in COPD. The study will provide important information about interventions designed to promote and maintain physical activity, improve patient outcomes and increase patients' choice relating to exercise and physical activity interventions. It will provide a rationale and data for an adequately powered clinical trial evaluating the effects of a physical activity intervention.
Read the detailed description
A survey of pulmonary rehabilitation programmes mirrored the results of other UK studies and highlighted that there are not enough programmes available; currently in the UK less than 1.5% of patients with COPD receive pulmonary rehabilitation per year. Only a proportion of patients are targeted i.e. those with moderate to severe disease. The majority of programmes are outpatient-based and are supervised by clinicians. This structured and supervised format of pulmonary rehabilitation does not meet the needs of all patients with high numbers of dropouts and non-adherence; yet alternative options for increasing physical activity for patients with COPD currently do not seem to be offered.
A home-based pedometer-driven walking intervention offers an alternative method of delivering physical activity training that could be provided to larger numbers of patients, at a lower cost and with flexibility around life commitments. It would also provide patients with more choice when deciding whether to participate in exercise or physical activity.
To date no study has compared a home-based walking intervention to structured, supervised pulmonary rehabilitation or the patient preferences or cost of the two programmes. For this reason, there is a need to compare a home-based-walking intervention to the standard method of providing patients with physical activity training, i.e. pulmonary rehabilitation. Therefore this study is essential as it will assess the feasibility of conducting a trial to investigate the efficacy of a physical activity intervention (physical activity consultation and a pedometer-based walking programme) versus pulmonary rehabilitation in improving physical activity in COPD.
- Being tested
- Physical Activity Intervention, Pulmonary Rehabilitation Programme
- Keywords
- Physical Activity, Pulmonary Rehabilitation, Chronic obstructive pulmonary disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity InterventionBehavioural
The 12 week home-based pedometer-driven walking programme will consist of weekly physical activity consultations. Pedometers will be used to set weekly step goals and motivate patients. Patients will wear the pedometer for 7 days and will record their daily steps in a step diary. At the next appointment the step target for the subsequent week will be agreed between the physiotherapist/researcher and participant. Each week thereafter the physiotherapist/researcher and patient will discuss their progress, document their mean daily step count for the previous week, and agree to a new daily step target for the subsequent week. The walking programme will be tailored to the individual and progressed on a weekly basis.
Pulmonary Rehabilitation ProgrammeBehavioural
This will be a 6-week supervised outpatient programme. The exercise component will last for one hour and be delivered twice weekly. It will consist of cardiovascular exercises and lower and upper body strengthening exercises. Education sessions will be delivered once weekly. Each patient will be provided with a home exercise programme to complete unsupervised once weekly.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Intervention | Experimental | 12 week home-based walking programme consisting of weekly physical activity consultations and a pedometer-driven walking programme Receives: Behavioral: Physical Activity Intervention |
| Pulmonary Rehabilitation Programme | Active comparator | 6-week supervised outpatient programme consisting of twice-weekly exercise sessions and once-weekly education sessions. Receives: Behavioral: Pulmonary Rehabilitation Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in physical activity will be assessed using step counts recorded with an Actigraph activity monitor.
The activity monitor is worn for 7 consecutive full days prior to the intervention, and 7 full days immediately after the intervention.
Measured: Baseline and at 6-weeks for PR group and 12-weeks for PA group
Secondary outcomes (10)
Change from baseline in time spent in physical activity and in sitting using the International Physical Activity Questionnaire
Measured: Baseline and at 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation
Change from baseline in exercise Capacity using the Incremental Shuttle Walk Test
Measured: Baseline, and at 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation
Change from baseline in Quality of Life using the EuroQOL-5D
Measured: Baseline, and at 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation
Change from baseline in Quality of Life using the COPD Assessment Test
Measured: Baseline, and at 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation
Stage of change in terms of physical activity using the Stages of Change Questionnaire
The Stages of Change Questionnaire is the temporal part of the transtheoretical model. It will be used to determine the current stage of change the participant is at in terms of their physical activity behaviour.
Measured: Baseline, and at 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation
Confidence to undertake physical activity using Marcus's Self-Efficacy Questionnaire
Marcus's Self-Efficacy Questionnaire is a component of the transtheoretical model which will provide more detailed information on each individual's confidence to undertake physical activity in different situations.
Measured: Baseline and at 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation
Patients' perceptions of both interventions will be obtained via semi-structured interviews.
Information will be collected with regards patient satisfaction with their exercise/activity, information regarding ease of execution, safety and tolerability of the programmes and the outcome measures, views about continuing exercise and suggestions for improving the programmes.
Measured: At 6-weeks for PR group and 12-weeks for PA group
Feasibility of the interventions
For both interventions information will be collected on recruitment and retention, dropouts, adherence and adverse events which will be necessary to establish feasibility.
Measured: End of study
Global Rating of Change Questionnaire
This is a numerical rating scale about their patient's perception of any change in their physical activity
Measured: At 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation
Physical activity will be assessed using step counts recorded with an Actigraph activity monitor.
Measured: At 18 (PR group) and 24 (PA group) weeks post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2016
- Study completion19 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Belfast Health and Social Care Trust, Western Health and Social Care Trust, Queen's University, Belfast, KU Leuven
- Responsible party
- Principal investigator, Brenda O'Neill, University of Ulster
- Investigators
- Brenda O'Neill, PhD, Principal investigator, University of Ulster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161393
- Sponsor's protocol ID
- WT12/20
- Acronym
- LIVELY
- Status last verified
- Aug 2017
- First submitted
- 28 May 2013
- Last updated
- 25 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhysicaL actIvity interVention vErsus puLmonarY Rehabilitation in COPD: The LIVELY COPD Project.
- ClinicalTrials.gov ID
- NCT02161393
- Acronym / sponsor ID
- LIVELY / WT12/20
- Keywords
- Physical Activity, Pulmonary Rehabilitation, Chronic obstructive pulmonary disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Belfast Health and Social Care Trust, Western Health and Social Care Trust, Queen's University, Belfast, KU Leuven
- Study start
- Feb 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- 19 Jan 2016 (actual)
- First posted
- 11 Jun 2014 (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.
The primary aim of this study is to assess the feasibility of conducting a trial to investigate the effectiveness of a physical activity intervention (physical activity consultation and a pedometer-based walking programme) versus pulmonary rehabilitation in improving physical activity in COPD.
Objectives are:
(i) to assess the feasibility (patient recruitment, adherence, drop-outs and adverse events) of delivering a physical activity intervention in the COPD patient population versus pulmonary rehabilitation; (ii) to explore users perceptions relating to satisfaction and benefits of a physical activity intervention versus pulmonary rehabilitation; (iii) to investigate between and within group change in physical activity, exercise capacity, quality of life, self-efficacy and changes in the transtheoretical model with the physical activity intervention versus pulmonary rehabilitation; and (iv) to examine the cost of delivering a physical activity intervention versus pulmonary rehabilitation for patients with COPD.
The hypothesis for this study is that it will be feasible to conduct a trial that will investigate the effectiveness of a physical activity intervention (physical activity consultation and a pedometer-based walking programme) compared to pulmonary rehabilitation for improving physical activity in COPD. The study will provide important information about interventions designed to promote and maintain physical activity, improve patient outcomes and increase patients' choice relating to exercise and physical activity interventions. It will provide a rationale and data for an adequately powered clinical trial evaluating the effects of a physical activity intervention.
Detailed description
A survey of pulmonary rehabilitation programmes mirrored the results of other UK studies and highlighted that there are not enough programmes available; currently in the UK less than 1.5% of patients with COPD receive pulmonary rehabilitation per year. Only a proportion of patients are targeted i.e. those with moderate to severe disease. The majority of programmes are outpatient-based and are supervised by clinicians. This structured and supervised format of pulmonary rehabilitation does not meet the needs of all patients with high numbers of dropouts and non-adherence; yet alternative options for increasing physical activity for patients with COPD currently do not seem to be offered.
A home-based pedometer-driven walking intervention offers an alternative method of delivering physical activity training that could be provided to larger numbers of patients, at a lower cost and with flexibility around life commitments. It would also provide patients with more choice when deciding whether to participate in exercise or physical activity.
To date no study has compared a home-based walking intervention to structured, supervised pulmonary rehabilitation or the patient preferences or cost of the two programmes. For this reason, there is a need to compare a home-based-walking intervention to the standard method of providing patients with physical activity training, i.e. pulmonary rehabilitation. Therefore this study is essential as it will assess the feasibility of conducting a trial to investigate the efficacy of a physical activity intervention (physical activity consultation and a pedometer-based walking programme) versus pulmonary rehabilitation in improving physical activity in COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Intervention | Experimental | Behavioral: Physical Activity Intervention12 week home-based walking programme consisting of weekly physical activity consultations and a pedometer-driven walking programme |
| Pulmonary Rehabilitation Programme | Active comparator | Behavioral: Pulmonary Rehabilitation Programme6-week supervised outpatient programme consisting of twice-weekly exercise sessions and once-weekly education sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The Patient must be referred to pulmonary rehabilitation.
- The Patient must have a Primary diagnosis of COPD
- The Patient must have a good understanding of written English (as reported by the individual patient)
- The Patient must be in a stable phase (not on antibiotics at the time of assessment with the ISWT), and deemed clinically stable by the clinical pulmonary rehabilitation team.
Key exclusion criteria (3 listed)
- The inability to safely take part in a walking programme or pulmonary rehabilitation (e.g. unstable angina, neurological, spinal or skeletal dysfunction affecting ability to exercise)
- The inability to comprehend or follow instructions (e.g. dementia).
- Clinically unstable (Pulmonary exacerbation or any change in symptoms and medication in the last 4 weeks)
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 |
|---|---|---|
| Physical Activity InterventionThe 12 week home-based pedometer-driven walking programme will consist of weekly physical activity consultations. Pedometers will be used to set weekly step goals and motivate patients. Patients will wear the pedometer for 7 days and will record their daily steps in a step diary. At the next appointment the step target for the subsequent week will be agreed between the physiotherapist/researcher and participant. Each week thereafter the physiotherapist/researcher and patient will discuss their progress, document their mean daily step count for the previous week, and agree to a new daily step target for the subsequent week. The walking programme will be tailored to the individual and progressed on a weekly basis. | Behavioural | Physical Activity Intervention |
| Pulmonary Rehabilitation ProgrammeThis will be a 6-week supervised outpatient programme. The exercise component will last for one hour and be delivered twice weekly. It will consist of cardiovascular exercises and lower and upper body strengthening exercises. Education sessions will be delivered once weekly. Each patient will be provided with a home exercise programme to complete unsupervised once weekly. | Behavioural | Pulmonary Rehabilitation Programme |
Primary outcome
Change from baseline in physical activity will be assessed using step counts recorded with an Actigraph activity monitor.
Time frame: Baseline and at 6-weeks for PR group and 12-weeks for PA group
The activity monitor is worn for 7 consecutive full days prior to the intervention, and 7 full days immediately after the intervention.
10 secondary outcomes
Change from baseline in time spent in physical activity and in sitting using the International Physical Activity Questionnaire
Time frame: Baseline and at 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation
Change from baseline in exercise Capacity using the Incremental Shuttle Walk Test
Time frame: Baseline, and at 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation
Change from baseline in Quality of Life using the EuroQOL-5D
Time frame: Baseline, and at 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation
Change from baseline in Quality of Life using the COPD Assessment Test
Time frame: Baseline, and at 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation
Stage of change in terms of physical activity using the Stages of Change Questionnaire
Time frame: Baseline, and at 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation
Confidence to undertake physical activity using Marcus's Self-Efficacy Questionnaire
Time frame: Baseline and at 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation
Patients' perceptions of both interventions will be obtained via semi-structured interviews.
Time frame: At 6-weeks for PR group and 12-weeks for PA group
Feasibility of the interventions
Time frame: End of study
Global Rating of Change Questionnaire
Time frame: At 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation
Physical activity will be assessed using step counts recorded with an Actigraph activity monitor.
Time frame: At 18 (PR group) and 24 (PA group) weeks post randomisation
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 25 Aug 2017.
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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.
Brenda O'Neill, PhD principal investigator
University of Ulster
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Intervention and Pulmonary Rehabilitation Programme in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Ulster at 2 sites 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 4 inclusion and 3 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 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Change from baseline in physical activity will be assessed using step counts recorded with an Actigraph activity monitor. (time frame: Baseline and at 6-weeks for PR group and 12-weeks for PA group). 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 25 Aug 2017.