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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: Pulmonary rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pulmonary rehabilitation	Other: Pulmonary rehabilitation; An exercise and education program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
arterial stiffness	aortic pulse wave velocity	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise capacity	Incremental Shuttle Walk Test (ISWT)	6 weeks
Physical activity level	steps counter pedometer	6 weeks
Change in dyspnea	Medical Research Council (MRC) dyspnoea scale	6 weeks
patient quality of life	COPD (CAT) assessment test	6 weeks

Collaborators and Investigators

• Sponsor: University College, London

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): July 21, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: December 20, 2016
• First Posted (Estimate): December 26, 2016

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 12, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 16/0446

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No