COPDABCOPDNCT04006015
Activity, Balance and COPD (ABCOPD)
An observational study of COPD, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This research project incorporates a series of studies to investigate the relationship between physical performance (e.g. tests of strength, balance and walking distance) and physical activity (activity measured in day to day life) in people with COPD and other chronic lung diseases. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- How many people
- 82 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jun 2019to Oct 2024
- Phase
- Observational
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with stable chronic lung disease.
Who may be able to join
- Adults with stable chronic lung disease
- Able to understand instructions.
- Age and sex matched healthy controls.
Who cannot join
- For the main study, the presence of other comorbidities causing a significant reduction in mobility (for example stroke with neurological deficits, severe arthritis, significant peripheral neuropathy, significant visual impairment, dementia etc.).
- exacerbation of lung disease within the last 2 months.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
National Heart and Lung Institute, Imperial College London
London
Keir EJ Philip, MRCP
About this study
Official title: Activity, Balance and COPD: An Exploratory Study of Physical Activity and Balance in Chronic Obstructive Pulmonary Disease (COPD)
This research project incorporates a series of studies to investigate the relationship between physical performance (e.g. tests of strength, balance and walking distance) and physical activity (activity measured in day to day life) in people with COPD and other chronic lung diseases.
Read the detailed description
The research project incorporates the following components:
Study 1) A prospective, observational study, to assess the relationship between a comprehensive set of measures of walking ability, strength and balance, and daily physical activity in people with chronic lung disease. Patients will attend a single assessment session to evaluate physical capacity. They will also wear a physical activity monitor for a week following completing these tests to assess physical activity and aspects of physical performance. Participants will also be invited to return two months later to provide evidence about the repeatability of measurements.
Study 2) A parallel study comparing assessment of performance during six-minute walk tests by an observer to a semi-automated assessment using an activity monitor worn by the patient. This will involve a single visit and be carried out during walking tests carried out as part of routine clinical care.
Study 3) A qualitative study to investigate experiences and perceptions of participants of dance groups for people with chronic lung disease, as a novel form of physical activity. This will be used to inform the design of subsequent trials of dance interventions for chronic lung disease.
- Conditions
- COPD
- Being tested
- No intervention being delivered.
- Keywords
- COPD
- 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.
No intervention being delivered.Other
No interventions are being delivered.
| Study group | Role | What they receive |
|---|---|---|
| Main study group | 31 people with COPD and 31 controls in the main study group. Receives: Other: No intervention being delivered. | |
| six-minute walk substudy | We will aim to have 40 participants participating in the 6 minute walk sub-study. Receives: Other: No intervention being delivered. | |
| Qualitative dance substudy | We will aim for 20 participants. Receives: Other: No intervention being delivered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free-living gait stability as assessed by activity monitor
The free-living gait stability parameters derived from the fixed body sensor worn during activity monitoring at home.
Measured: 7 days.
Secondary outcomes (10)
Physical activity assessed by step count using activity monitor
Physical activity assessed using step count (number of steps), as assessed using the activity monitor at home (McRoberts MoveMonitor).
Measured: 7 days.
Clinical balance assessment
Assessed using the miniBESTest in clinical setting.
Measured: Assessed during single clinical assessement at baseline.
Physical performance assessment
Assessed using the Short Physical Performance Battery (SPPB) in clinical setting.
Measured: Assessed during single clinical assessment at baseline.
Balance confidence
Assessed using the Activities-specific Balance Confidence (ABC) scale. This is a self completed measure of balance confidence during common activities of daily living. It includes 16 questions which participant give a percentage confidence response with 0% being not confident at all and 100% being completely confident. There is also a total score out from 0% (least confident) to 100% (most confident) for overall balance confidence, which average created by combining the scores given for the separate questions.
Measured: Assessed during a single clinical assessment at baseline.
Walking distance in metres
Assessed using the six-minute walk test in clinical setting.
Measured: Assessed during a single clinical assessment at baseline.
Patient experience as assessed by semi-structured interviews
The patients experience assessed by semi-structured interviews in focus group.
Measured: 1 hour.
Physical Activity: Movement intensity (in average body acceleration (g) during activity)
Movement intensity measurement is assessed using the fixed body sensor worn during activity monitoring at home.
Measured: 7 days.
Physical activity: types of activity (time in minutes spent standing, walking, lying, sitting, cycling, running) assessed with activity monitor.
Types of activity (time measured in minutes spent standing, walking, lying, sitting, cycling, running) is assessed using the fixed body sensor worn during activity monitoring at home.
Measured: 7 days.
Timed Up and Go (TUG)
Time in seconds to complete the standard TUG protocol
Measured: Assessed during a single clinical assessment at baseline.
Functional reach test
Assessed using standard functional reach protocol
Measured: Assessed during a single clinical assessment at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start24 Jun 2019
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Hopkinson, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006015
- Sponsor's protocol ID
- IRAS Project ID: 258399
- Acronym
- ABCOPD
- Status last verified
- Dec 2023
- First submitted
- 24 Jun 2019
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Philip KEJ, Lewis A, Williams S, Buttery SC, Polkey MI, Man W, Fancourt D, Hopkinson NS. Dance for people with chronic respiratory disease: a qualitative study. BMJ Open. 2020 Oct 13;10(10):e038719. doi: 10.1136/bmjopen-2020-038719.
PubMed 33051234
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activity, Balance and COPD: An Exploratory Study of Physical Activity and Balance in Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT04006015
- Acronym / sponsor ID
- ABCOPD / IRAS Project ID: 258399
- Conditions
- COPD
- Keywords
- COPD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 2 Jul 2019 (actual)
- 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 research project incorporates a series of studies to investigate the relationship between physical performance (e.g. tests of strength, balance and walking distance) and physical activity (activity measured in day to day life) in people with COPD and other chronic lung diseases.
Detailed description
The research project incorporates the following components:
Study 1) A prospective, observational study, to assess the relationship between a comprehensive set of measures of walking ability, strength and balance, and daily physical activity in people with chronic lung disease. Patients will attend a single assessment session to evaluate physical capacity. They will also wear a physical activity monitor for a week following completing these tests to assess physical activity and aspects of physical performance. Participants will also be invited to return two months later to provide evidence about the repeatability of measurements.
Study 2) A parallel study comparing assessment of performance during six-minute walk tests by an observer to a semi-automated assessment using an activity monitor worn by the patient. This will involve a single visit and be carried out during walking tests carried out as part of routine clinical care.
Study 3) A qualitative study to investigate experiences and perceptions of participants of dance groups for people with chronic lung disease, as a novel form of physical activity. This will be used to inform the design of subsequent trials of dance interventions for chronic lung disease.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Main study group | – | Other: No intervention being delivered.31 people with COPD and 31 controls in the main study group. |
| six-minute walk substudy | – | Other: No intervention being delivered.We will aim to have 40 participants participating in the 6 minute walk sub-study. |
| Qualitative dance substudy | – | Other: No intervention being delivered.We will aim for 20 participants. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with stable chronic lung disease.
Key inclusion criteria (3 listed)
- Adults with stable chronic lung disease
- Able to understand instructions.
- Age and sex matched healthy controls.
Key exclusion criteria (2 listed)
- For the main study, the presence of other comorbidities causing a significant reduction in mobility (for example stroke with neurological deficits, severe arthritis, significant peripheral neuropathy, significant visual impairment, dementia etc.).
- exacerbation of lung disease within the last 2 months.
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 |
|---|---|---|
| No intervention being delivered.No interventions are being delivered. | Other | Main study group, Qualitative dance substudy, six-minute walk substudy |
Primary outcome
Free-living gait stability as assessed by activity monitor
Time frame: 7 days.
The free-living gait stability parameters derived from the fixed body sensor worn during activity monitoring at home.
10 secondary outcomes
Physical activity assessed by step count using activity monitor
Time frame: 7 days.
Clinical balance assessment
Time frame: Assessed during single clinical assessement at baseline.
Physical performance assessment
Time frame: Assessed during single clinical assessment at baseline.
Balance confidence
Time frame: Assessed during a single clinical assessment at baseline.
Walking distance in metres
Time frame: Assessed during a single clinical assessment at baseline.
Patient experience as assessed by semi-structured interviews
Time frame: 1 hour.
Physical Activity: Movement intensity (in average body acceleration (g) during activity)
Time frame: 7 days.
Physical activity: types of activity (time in minutes spent standing, walking, lying, sitting, cycling, running) assessed with activity monitor.
Time frame: 7 days.
Timed Up and Go (TUG)
Time frame: Assessed during a single clinical assessment at baseline.
Functional reach test
Time frame: Assessed during a single clinical assessment at baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Derived from this study: PubMed 33051234Philip KEJ, Lewis A, Williams S, Buttery SC, Polkey MI, Man W, Fancourt D, Hopkinson NS. Dance for people with chronic respiratory disease: a qualitative study. BMJ Open. 2020 Oct 13;10(10):e038719. doi: 10.1136/bmjopen-2020-038719.
- Individual participant dataSharing planned: No
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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.
Nicholas Hopkinson, PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Imperial College London 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 2 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: status not confirmed, as of the sponsor's last update on 8 Dec 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keir EJ Philip, MRCP (0044(0)2073528121 ext. 8029, k.philip@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free-living gait stability as assessed by activity monitor (time frame: 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04006015, which also lists 1 linked publication.
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 8 Dec 2023; AzTrials last refreshed its copy on 28 Oct 2026.