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CompletedNCT03003208Updated Mar 16, 2021

Pulmonary Rehabilitation and Cardiovascular Risk in COPD

An interventional study of Pulmonary rehabilitation in COPD, sponsored by University College, London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-16.

Sponsored by University College, London · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
95
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • COPD
03

In context

Lead sponsor

University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Neuromuscular diagnosis.
  • Patient involved in any ongoing drug intervention study.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
95 participants (actual)

Study arms

  • Other
    Pulmonary rehabilitation

    Other: Pulmonary rehabilitation

Interventions

  • OtherPulmonary rehabilitation

    An exercise and education program

06

What researchers measure

Primary outcomes

  1. arterial stiffness

    aortic pulse wave velocity

    Time frame: 6 weeks

Secondary outcomes

  1. Exercise capacity

    Incremental Shuttle Walk Test (ISWT)

    Time frame: 6 weeks

  2. Physical activity level

    steps counter pedometer

    Time frame: 6 weeks

  3. Change in dyspnea

    Medical Research Council (MRC) dyspnoea scale

    Time frame: 6 weeks

  4. patient quality of life

    COPD (CAT) assessment test

    Time frame: 6 weeks

07

Study locations

1 site
  • Royal Free Hospital NHS
    London, Nw3 2pf, United Kingdom
08

References and documents

Publications

  • Aldabayan YS, Ridsdale HA, Alrajeh AM, Aldhahir AM, Lemson A, Alqahtani JS, Brown JS, Hurst JR. Pulmonary rehabilitation, physical activity and aortic stiffness in COPD. Respir Res. 2019 Jul 24;20(1):166. doi: 10.1186/s12931-019-1135-6. PubMed 31340825 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03003208
Lead sponsor
University College, London
Responsible party
Sponsor
First posted
Dec 26, 2016
Start date
Feb 1, 2017
Primary completion
Jul 21, 2018
Completion
Aug 1, 2018
Last update
Mar 16, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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