Mechanisms of Exercise Intolerance in Chronic Obstructive Pulmonary Disease
COPD
1 other identifier
interventional
18
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2015
1 active site
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
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedFirst Posted
Study publicly available on registry
February 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJune 16, 2016
June 1, 2016
1.2 years
January 19, 2015
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
EXPERIMENTALAcute exercise bouts
Healthy
ACTIVE COMPARATORAcute exercise bouts
Interventions
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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