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OpenTrials
Completed

NCT Number: NCT03003208

Pulmonary Rehabilitation and Cardiovascular Risk in COPD

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Free Hospital NHS

London, NW3 2PF, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulmonary Rehabilitation

Other

An exercise and education program

Primary outcomes

  1. arterial stiffness

    Time frame: 6 weeks

    aortic pulse wave velocity

Secondary outcomes

  1. Exercise capacity

    Time frame: 6 weeks

    Incremental Shuttle Walk Test (ISWT)

  2. Physical activity level

    Time frame: 6 weeks

    steps counter pedometer

  3. Change in dyspnea

    Time frame: 6 weeks

    Medical Research Council (MRC) dyspnoea scale

  4. patient quality of life

    Time frame: 6 weeks

    COPD (CAT) assessment test

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 26, 2016
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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