NCT03003208

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 26, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2018

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

December 15, 2016

Last Update Submit

March 12, 2021

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

  • arterial stiffness

    aortic pulse wave velocity

    6 weeks

Secondary Outcomes (4)

  • Exercise capacity

    6 weeks

  • Physical activity level

    6 weeks

  • Change in dyspnea

    6 weeks

  • patient quality of life

    6 weeks

Study Arms (1)

Pulmonary rehabilitation

OTHER
Other: Pulmonary rehabilitation

Interventions

Pulmonary rehabilitationOTHER

An exercise and education program

Pulmonary rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Free Hospital NHS

London, NW3 2PF, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 31340825DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2016

First Posted

December 26, 2016

Study Start

February 1, 2017

Primary Completion

July 21, 2018

Study Completion

August 1, 2018

Last Updated

March 16, 2021

Record last verified: 2021-03

Locations

GB(1)