Mechanisms of Exercise Intolerance in Chronic Obstructive Pulmonary Disease

COPD Clinical Trial

— COPD  

Official title:

Mechanisms of Exercise Intolerance in Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360865
• Other study ID #: H-2-2013-150 - project 2
• Status: Completed
• Phase: N/A
• First received: January 19, 2015
• Last updated: June 15, 2016
• Start date: February 2015
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Unstable ischemic heart disease,

• severe heart valve failure,

• pulmonary emboli,

• severe heart failure,

• severe infections,

• musculoskeletal disorders,

• malignant disease,

• contraindicated medicine as anticoagulants.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Exercise

Locations

Country	Name	City	State
Denmark	Centre of Physical Activity Research	Copenhagen	Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No