NCT02875522

Brief Summary

The primary cause of chronic obstructive pulmonary disease is smoking, which can lead to inflammation in the lungs and blood vessels that can lead to secondary problems such as blood vessel disease, high blood pressure and heart disease. Aerobic exercise training has been shown to reduce the risk of heart and brain disease; however, it is currently unknown whether exercise training can have the same affect in patients with COPD. The aim of this study is to investigate how eight weeks of aerobic exercise training improves blood vessel and heart function and brain blood flow in patients with COPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

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

Study Start

First participant enrolled

January 1, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
Last Updated

August 23, 2016

Status Verified

August 1, 2016

Enrollment Period

3.3 years

First QC Date

August 4, 2016

Last Update Submit

August 17, 2016

Conditions

Keywords

COPDExercise TrainingFlow-Mediated DilationArterial StiffnessEchocardiographyCerebrovascular Physiology

Outcome Measures

Primary Outcomes (1)

  • Endothelial Function

    The change in brachial artery flow mediated dilation measured using reactive hyperaemia

    8-weeks (following 24 sessions of exercise training)

Secondary Outcomes (9)

  • Arterial Stiffness

    8-weeks (following 24 sessions of exercise training)

  • Carotid intima-medial thickness

    8-weeks (following 24 sessions of exercise training)

  • Carotid Compliance

    8-weeks (following 24 sessions of exercise training)

  • Inflammatory Biomarkers

    8-weeks (following 24 sessions of exercise training)

  • Systolic function

    8-weeks (following 24 sessions of exercise training)

  • +4 more secondary outcomes

Study Arms (2)

Patients with COPD

EXPERIMENTAL

Stable patients with COPD participated in an 8-week (24 session) individualized, non-linear aerobic exercise training program consisting of upper and lower body cycle ergometry.

Other: Individualized, non-linear aerobic exercise training

Healthy Controls

ACTIVE COMPARATOR

Age, sex, BMI and activity matched controls participated in an 8-week (24 session) individualized, non-linear aerobic exercise training program consisting of upper and lower body cycle ergometry.

Other: Individualized, non-linear aerobic exercise training

Interventions

Aerobic exercise performed on lower body stationary ergometer and an upper extremity arm crank. Intensity (50-95% workload maximum) and durations (20-45 min) are fluctuated daily to optimize training stress and adaptation

Healthy ControlsPatients with COPD

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-smokers (\>6 months);
  • Forced expiratory volume in one second/ forced vital capacity (FEV1/FVC) \< 0.7 and FEV1/FVC \<lower limit of normal
  • Stable (\>3 months exacerbation free)

You may not qualify if:

  • On supplemental oxygen;
  • Known cardiac or cerebral vascular disease, diabetes, obstructive sleep apnea;
  • Uncontrolled hypertension;
  • BMI \>30kg/m2
  • Currently performing pulmonary rehabilitation or structured exercise training;
  • Desaturate during exercise (SpO2\<85%)
  • Cardiovascular contraindications to exercise in the incremental test used for screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Kelowna, British Columbia, V1V 1V7, Canada

Location

Related Publications (1)

  • Gelinas JC, Lewis NC, Harper MI, Ainslie PN, Rolf JD, Eves ND. Aerobic Exercise Training on Peripheral Vascular Structure and Function in Patients with Chronic Obstructive Pulmonary Disease. American Journal of Respiratory and Critical Care Medicine, 191:A5305, 2015.

    BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Neil Eves, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 23, 2016

Study Start

January 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

August 23, 2016

Record last verified: 2016-08

Locations