NCT02360865

Brief Summary

1: Is endothelium function impaired in COPD? Other chronic cardiovascular diseases are associated with endothelial dysfunction, and the endothelium plays an important role in regulating vascular tone, tissue blood flow, coagulation and the inflammation process. Although the specific causes of endothelial dysfunction remain unclear, physical inactivity, chronic systemic inflammation and smoking are all known to be associated with endothelial abnormality. 2\. Is Muscular Sympathetic Nerve Activity (MSNA) increased in COPD? A balanced regulation of blood flow to skeletal muscles may be disturbed by pathophysiology and may therefore contribute to the exercise intolerance and skeletal muscle depletion seen in patients with COPD.Skeletal muscle blood flow is tightly regulated to match tissue oxygen demands and is thus adapted to meet energy requirements. During physical activity, the sympathetic nervous system is activated ("exercise pressor reflex"), resulting in increased ventilation, heart rate and a redistribution of cardiac output from inactive to active tissues. The redistribution of cardiac output to the body organs is heterogeneous. Blood flow to skeletal, respiratory and cardiac muscle increases as exercise intensity increases, whereas blood flow to gastrointestinal, renal and reproductive tissues decreases. As blood pressure during exercise remains largely unchanged, the redistribution of blood flow is caused by changes in vascular conductance. These conductance changes are caused by an overall vasoconstriction induced by the increased sympathetic outflow of noradrenaline (NA), and a vasodilation of vascular beds supplying the working skeletal -, cardiac- and respiratory muscle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 16, 2016

Status Verified

June 1, 2016

Enrollment Period

1.2 years

First QC Date

January 19, 2015

Last Update Submit

June 15, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Endothelium function during acute exercise (one legged kicking) by Flow doppler

    Flow doppler

    On one experimental day during acute exercise (one legged knicking) and change from baseline

  • Muscular Sympathetic Nerve Activity During acute exercise (handgrip and leg isometric leg extension) by Peroneal microneurography

    On one experimental day during acute exercise (handgrib and leg isometric leg extension) and change from baseline

Study Arms (2)

COPD

EXPERIMENTAL

Acute exercise bouts

Other: Exercise

Healthy

ACTIVE COMPARATOR

Acute exercise bouts

Other: Exercise

Interventions

COPDHealthy

Eligibility Criteria

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

You may qualify if:

  • Forced Expiratory Volume at on second/ Forced Vital Capacity fixed ratio \<0.70, - Forced Expiratory Volume at one second \<60% of predicted and Medical
  • Research Council scale \> or equal to 3
  • Arterial oxygen saturation at rest\> 90%,
  • Body Mass Index \>18,
  • Left Ventricle Ejection Fraction\> 45.

You may not qualify if:

  • Unstable ischemic heart disease,
  • severe heart valve failure,
  • pulmonary emboli,
  • severe heart failure,
  • severe infections,
  • musculoskeletal disorders,
  • malignant disease,
  • contraindicated medicine as anticoagulants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre of Physical Activity Research

Copenhagen, Capital Region, 2100, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 19, 2015

First Posted

February 11, 2015

Study Start

February 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 16, 2016

Record last verified: 2016-06

Locations