| Condition or disease | Intervention/treatment |
|---|---|
| COPD | Other: No intervention being delivered. |
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 Type : | Observational |
| Estimated Enrollment : | 82 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Cross-Sectional |
| Official Title: | Activity, Balance and COPD: An Exploratory Study of Physical Activity and Balance in Chronic Obstructive Pulmonary Disease (COPD) |
| Actual Study Start Date : | June 24, 2019 |
| Estimated Primary Completion Date : | October 2021 |
| Estimated Study Completion Date : | March 2022 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Main study group
31 people with COPD and 31 controls in the main study group.
|
Other: No intervention being delivered.
No interventions are being delivered.
|
|
six-minute walk substudy
We will aim to have 40 participants participating in the 6 minute walk sub-study.
|
Other: No intervention being delivered.
No interventions are being delivered.
|
|
Qualitative dance substudy
We will aim for 20 participants.
|
Other: No intervention being delivered.
No interventions are being delivered.
|
| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Keir EJ Philip, MRCP | 0044(0)2073528121 ext 8029 | k.philip@imperial.ac.uk |
| United Kingdom | |
| National Heart and Lung Institute, Imperial College London | Recruiting |
| London, United Kingdom | |
| Contact: Keir EJ Philip, MRCP | |
| Principal Investigator: | Nicholas Hopkinson, PhD | Imperial College London |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 24, 2019 | ||||
| First Posted Date | July 2, 2019 | ||||
| Last Update Posted Date | December 17, 2019 | ||||
| Actual Study Start Date | June 24, 2019 | ||||
| Estimated Primary Completion Date | October 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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.
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Activity, Balance and COPD (ABCOPD) | ||||
| Official Title | Activity, Balance and COPD: An Exploratory Study of Physical Activity and Balance in Chronic Obstructive Pulmonary Disease (COPD) | ||||
| Brief 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. | ||||
| 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. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Cross-Sectional |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Adults with stable chronic lung disease. | ||||
| Condition | COPD | ||||
| Intervention | Other: No intervention being delivered.
No interventions are being delivered.
|
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| Study Groups/Cohorts |
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| 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. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
82 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | March 2022 | ||||
| Estimated Primary Completion Date | October 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 99 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts |
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| Listed Location Countries | United Kingdom | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04006015 | ||||
| Other Study ID Numbers | IRAS Project ID: 258399 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Imperial College London | ||||
| Study Sponsor | Imperial College London | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Imperial College London | ||||
| Verification Date | December 2019 | ||||