Physical Activity Intervention and Cardiovascular Risk Markers in COPD
NCT ID: NCT03869112
Last Updated: 2019-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2019-04-01
2020-02-01
Brief Summary
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Before and after interventions measures will be taken including exercise capacity, body composition, blood tests, arterial stiffness, questionnaires assessing health quality of life, anxiety and depression, symptoms, cardiovascular disease risk.
The investigators will also have a sub-group study. The subgroup study will have two arms interventions which are pulmonary rehabilitation group and physical activity group. The investigators will recruit 10 participants for each group from the main groups' population (no usual care group). Additional before and after measures will be taken for sub-group study and that includes Magnetic resonance imaging (MRI) scanning for adipose visceral tissue and postprandial lipaemic response test.
It is hypothesised that exercise and physical activity level can reduce cardiovascular disease risk with COPD patients, but the relative impact of both interventions need to be explored.
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Detailed Description
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However, the outcomes of both interventions have not been extensively investigated, nor have they been directly compared. The immediate effects of pulmonary rehabilitation and PA interventions on cardiovascular risk factors for individuals with COPD have not been extensively investigated or compared.
Therefore, the purpose of this study is to examine the feasibility of conducting a trial to compare the impact of pulmonary rehabilitation and physical activity interventions in a number of important clinical outcomes including cardiovascular risk.
Investigation and data collection will be taking place within University Hospitals of Leicester NHS trust sites. The investigators are aiming to recruit 50 COPD patients who are eligible for a pulmonary rehabilitation programme to investigate the effect of physical activity intervention compared to pulmonary rehabilitation with respect to cardiovascular risks.
The study will measure various outcomes, immediately before, immediately after interventions. These outcomes will include measures in aerobic fitness (walking test), strength tests, physical activity level, quality of life, breathlessness questionnaires. In addition, blood sampling and body measurements will be completed. The investigators will also measure arterial stiffness with a non-invasive technique. Arterial stiffness is a hardening of the artery wall.
In a subgroup study, 20 participants will have additional visits and measures. The investigators will be doing magnetic resonance imaging (MRI), diagnostic pictures of the inside of the body which is used for picturing the fat tissue around the abdomen. The investigators will be also doing a postprandial lipaemic test which is testing the fat level in the circulating blood after a high-fat meal. The investigators will do this test as before and after the intervention to allow for comparison.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Physical activity intervention
Physical activity group will be given a FitBit device to monitor their PA, especially steps count Step targets will be discussed with the participants with a view to increasing their daily physical activity over the 6 week period. A recent protocol has been described that encouraged an increase of 500 steps weekly. This was well tolerated by participants (Demeyer, Louvaris et al. 2017). This will be an unsupervised, home based intervention.
Physical activity intervention
Physical activity group will be given a charge 2 FitBit device to monitor their PA specially steps count, step targets will be discussed with the participants with a view to increasing their daily physical activity over the 6 week period. A recent protocol has been described that encouraged an increase of 500 steps weekly. This was well tolerated by participants (Demeyer, Louvaris et al. 2017). This will be an unsupervised, home-based intervention.
Pulmonary rehabilitation group
Pulmonary rehabilitation group is a 6-week intervention of supervised exercise and group education and will follow the BTS guidelines. (Bolton, Bevan-Smith et al. 2013)
Pulmonary rehabilitation group
Pulmonary rehabilitation group is a 6-week intervention of supervised exercise and group education and will follow the BTS guidelines. (Bolton, Bevan-Smith et al. 2013)
Usual care
Usual care group will have the standard follow up care by rehabilitation clinic without being in any physical intervention.
No interventions assigned to this group
Interventions
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Physical activity intervention
Physical activity group will be given a charge 2 FitBit device to monitor their PA specially steps count, step targets will be discussed with the participants with a view to increasing their daily physical activity over the 6 week period. A recent protocol has been described that encouraged an increase of 500 steps weekly. This was well tolerated by participants (Demeyer, Louvaris et al. 2017). This will be an unsupervised, home-based intervention.
Pulmonary rehabilitation group
Pulmonary rehabilitation group is a 6-week intervention of supervised exercise and group education and will follow the BTS guidelines. (Bolton, Bevan-Smith et al. 2013)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or Female, aged 40 years to 85 years.
* Diagnosed with COPD
* Able (in the Investigators opinion) and willing to comply with all study requirements.
* Participant is willing to attend visits at baseline and 8 weeks (sub-group: baseline, 8 weeks)
* Able to read and understand English
Exclusion Criteria
* Attended a pulmonary rehabilitation programme or participating in a physical activity intervention study in current time or in the last 6 months.
* Any other significant diseases or disorders that are a contraindication to be enrolled in a pulmonary rehabilitation programme.
40 Years
85 Years
ALL
No
Sponsors
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Loughborough University
OTHER
University Hospitals, Leicester
OTHER
Responsible Party
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Tareq Alotaibi
Principal investigator
Principal Investigators
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Sally Singh, Professor
Role: STUDY_CHAIR
University Hospital of Leicester NHS Tust
Locations
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University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Li J, Siegrist J. Physical activity and risk of cardiovascular disease--a meta-analysis of prospective cohort studies. Int J Environ Res Public Health. 2012 Feb;9(2):391-407. doi: 10.3390/ijerph9020391. Epub 2012 Jan 26.
Gimeno-Santos E, Frei A, Steurer-Stey C, de Batlle J, Rabinovich RA, Raste Y, Hopkinson NS, Polkey MI, van Remoortel H, Troosters T, Kulich K, Karlsson N, Puhan MA, Garcia-Aymerich J; PROactive consortium. Determinants and outcomes of physical activity in patients with COPD: a systematic review. Thorax. 2014 Aug;69(8):731-9. doi: 10.1136/thoraxjnl-2013-204763. Epub 2014 Feb 20.
Triest FJ, Singh SJ, Vanfleteren LE. Cardiovascular risk, chronic obstructive pulmonary disease and pulmonary rehabilitation: Can we learn from cardiac rehabilitation? Chron Respir Dis. 2016 Aug;13(3):286-94. doi: 10.1177/1479972316642367. Epub 2016 Apr 14.
Shortreed SM, Peeters A, Forbes AB. Estimating the effect of long-term physical activity on cardiovascular disease and mortality: evidence from the Framingham Heart Study. Heart. 2013 May;99(9):649-54. doi: 10.1136/heartjnl-2012-303461. Epub 2013 Mar 8.
Related Links
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Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD). . 2017
Other Identifiers
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18/EM/0270
Identifier Type: -
Identifier Source: org_study_id
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