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Pulmonary Rehabilitation and Cardiovascular Risk in COPD

Pulmonary Rehabilitation and Cardiovascular Risk in COPD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03003208
Enrollment
95
Registered
2016-12-26
Start date
2017-02-01
Completion date
2018-08-01
Last updated
2021-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Brief summary

Chronic obstructive pulmonary disease (COPD) is a common smoking-related lung disease. Patients with COPD are at increased risk of developing cardiovascular disease such as heart attacks and strokes. A simple measurement called arterial stiffness is a good assessment of how likely people are to have cardiovascular disease, both in healthy populations and those with COPD. Aortic Pulse wave velocity (aPWV) measures arterial stiffness, Pulmonary Rehabilitation (PR) - a 6 week supervised group exercise and education class - is an effective intervention in COPD to reduce symptoms, improve exercise performance and prevent exacerbations. However, the effect of PR on cardiovascular risk in COPD is controversial as two small positive studies suggested benefit and one larger study did not. Investigators have recently shown that cardiovascular risk is higher in those COPD patients who get the most infections (exacerbations). PR is an effective intervention for preventing COPD exacerbations. Logically, the exercise component would be expected to reduce cardiovascular risk too. Investigators want to identify which patients with COPD get cardiovascular benefit from a PR programme and why others do not. Investigators propose to measure aPWV before and after PR. Investigators will then classify participants as responders or non-responders defined as the presence or absence of a significant improvement in aPWV. Investigators will be collecting demographic and clinical information including daily physical activity level and how effective the PR has been to enable the investigators to identify the characteristics of patients who do, and do not achieve cardiovascular risk reduction in response to PR in COPD. This will inform on better design of PR programmes for people living with COPD.

Interventions

OTHERPulmonary rehabilitation

An exercise and education program

Sponsors

University College, London
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient diagnosed with COPD. The patient must be referred to PR from his/her physician with spirometry results confirming that he/she has chronic obstructive pulmonary disease (defined as post-bronchodilator FEV1/VC \<0.70 and a compatible exposure history). * Ability to exercise.

Exclusion criteria

* Neuromuscular diagnosis. * Patient involved in any ongoing drug intervention study.

Design outcomes

Primary

MeasureTime frameDescription
arterial stiffness6 weeksaortic pulse wave velocity

Secondary

MeasureTime frameDescription
Exercise capacity6 weeksIncremental Shuttle Walk Test (ISWT)
Physical activity level6 weekssteps counter pedometer
Change in dyspnea6 weeksMedical Research Council (MRC) dyspnoea scale
patient quality of life6 weeksCOPD (CAT) assessment test

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026