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Muscle Dysfunction in Patients With Chronic Obstructive Lung Disease (COPD): the Role of Sympathetic Activation

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
non-invasive ventilation (NIV)
Sponsored by
University Medical Center Goettingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosis of COPD II or III according to the GOLD guidelines
  • FEV1 of less than 60% of the predicted value
  • RV/TLC > 45%
  • Optimal stable medication according to the GOLD guidelines for at least 2 weeks
  • The last exacerbation must not be more recent than three weeks
  • Stable sinus rhythm
  • The subgroup on NIV should be stable on NIV for > 1 month

Exclusion Criteria:

  • not willing or unable to sign the informed consent before the study begins
  • Age under 30 or over 80 years
  • paO2< 55 mmHg or PaCO2 > 45 mmHg on arterial blood gas analysis (For patients on NIV, PaCO2 values of up to 55 mmHg are acceptable.)
  • Treatment with drugs having direct sympathomimetic activity (e.g. theophylline, moxonidine, clonidine)
  • Oral medication with beta2 sympathomimetics (therapy with long-acting inhaled beta2 sympathomimetics is permitted)
  • History of sleep apnoea or documented evidence of > 15 episodes of apneas and/or hypopnea per hour during sleep. An episode of apnea is defined as the cessation of inspiratory airflow for 10 s or more. Hypopnea is defined as a reduction in airflow (> 50%) lasting for more than 10 s in comparison with the maximum airflow recorded during the preceding breathing cycle.
  • Myocardial infarction (MI) or a coronary revascularization procedure within the previous 2 calendar months
  • Clinically evident polyneuropathy
  • Diabetes mellitus necessitating any pharmacologic therapy
  • Severe (i.e., life-limiting) concomitant disease, including life-threatening malignancy (cancer likely to reduce life expectancy to less than 5 years), acquired immune deficiency syndrome, or any other life-threatening disease.
  • Diuretics should not be taken before measurements

Sites / Locations

  • Universitaetsmedizin Goettingen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

No Intervention

Arm Label

COPD

COPD with non-invasive ventilation (NIV)

Healthy control subjects

Arm Description

Starting non-invasive ventilation with the patient's own device during registration of MSNA.

Outcomes

Primary Outcome Measures

muscle sympathetic nerve activity (MSNA)
In a 90 minute microneurographic measurement muscle sympathetic nerve activity is assessed.
Arterial stiffness

Secondary Outcome Measures

VE/VCO2

Full Information

First Posted
December 9, 2012
Last Updated
May 9, 2014
Sponsor
University Medical Center Goettingen
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1. Study Identification

Unique Protocol Identification Number
NCT01750489
Brief Title
Muscle Dysfunction in Patients With Chronic Obstructive Lung Disease (COPD): the Role of Sympathetic Activation
Official Title
Skeletal and Respiratory Muscle Dysfunction in Patients With COPD: the Role of Sympathetic Activation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Goettingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of the project is to better understand the causes of exercise limitation, dyspnea and neurohumoral activation in patients with COPD. In particular, the investigators aim to explore the mutual interaction of neurohumoral activation and exercise limitation thereby focussing on differential effects of the peripheral muscle and the diaphragm. Eventually the findings might influence treatment modalities. If sympathetic activation contributes to exercise limitation then drugs influencing the autonomic nervous system would be a reasonable therapeutic concept. If a reduction of sympathetic activity due to an alteration of the ergoreflex can be achieved by non-invasive ventilation this would help to improve dyspnea and exercise capacity.
Detailed Description
Our aim is to investigate whether reduced exercise capacity, increased respiratory drive and dyspnoea are linked to heightened sympathetic activation at rest and during exercise in patients with COPD. Furthermore, the effect of unloading the respiratory muscles by using non-invasive ventilation (NIV) will be assessed. Fifteen stable COPD patients without NIV will be matched to 15 healthy control subjects (with sufficient microneurography recording). Furthermore COPD patients on regular NIV will be studied. Each participant will undergo symptom limited bicycle exercise and a handgrip protocol. Microneurography will be used to quantify sympathetic activity by the transcutaneous registration of postganglionic sympathetic efferents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Arm Title
COPD
Arm Type
No Intervention
Arm Title
COPD with non-invasive ventilation (NIV)
Arm Type
Experimental
Arm Description
Starting non-invasive ventilation with the patient's own device during registration of MSNA.
Arm Title
Healthy control subjects
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
non-invasive ventilation (NIV)
Primary Outcome Measure Information:
Title
muscle sympathetic nerve activity (MSNA)
Description
In a 90 minute microneurographic measurement muscle sympathetic nerve activity is assessed.
Time Frame
90 minutes
Title
Arterial stiffness
Time Frame
90 min
Secondary Outcome Measure Information:
Title
VE/VCO2
Time Frame
During 8-15 minutes bicycle exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosis of COPD II or III according to the GOLD guidelines FEV1 of less than 60% of the predicted value RV/TLC > 45% Optimal stable medication according to the GOLD guidelines for at least 2 weeks The last exacerbation must not be more recent than three weeks Stable sinus rhythm The subgroup on NIV should be stable on NIV for > 1 month Exclusion Criteria: not willing or unable to sign the informed consent before the study begins Age under 30 or over 80 years paO2< 55 mmHg or PaCO2 > 45 mmHg on arterial blood gas analysis (For patients on NIV, PaCO2 values of up to 55 mmHg are acceptable.) Treatment with drugs having direct sympathomimetic activity (e.g. theophylline, moxonidine, clonidine) Oral medication with beta2 sympathomimetics (therapy with long-acting inhaled beta2 sympathomimetics is permitted) History of sleep apnoea or documented evidence of > 15 episodes of apneas and/or hypopnea per hour during sleep. An episode of apnea is defined as the cessation of inspiratory airflow for 10 s or more. Hypopnea is defined as a reduction in airflow (> 50%) lasting for more than 10 s in comparison with the maximum airflow recorded during the preceding breathing cycle. Myocardial infarction (MI) or a coronary revascularization procedure within the previous 2 calendar months Clinically evident polyneuropathy Diabetes mellitus necessitating any pharmacologic therapy Severe (i.e., life-limiting) concomitant disease, including life-threatening malignancy (cancer likely to reduce life expectancy to less than 5 years), acquired immune deficiency syndrome, or any other life-threatening disease. Diuretics should not be taken before measurements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Andreas, Professor
Organizational Affiliation
Universitaetsmedizin Goettingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitaetsmedizin Goettingen
City
Goettingen
ZIP/Postal Code
37075
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
18385175
Citation
Raupach T, Bahr F, Herrmann P, Luethje L, Heusser K, Hasenfuss G, Bernardi L, Andreas S. Slow breathing reduces sympathoexcitation in COPD. Eur Respir J. 2008 Aug;32(2):387-92. doi: 10.1183/09031936.00109607. Epub 2008 Apr 2.
Results Reference
background
Links:
URL
http://www.lungenfachklinik-immenhausen.de/
Description
Information about research facility
URL
http://www.med.uni-goettingen.de
Description
Information about research facility

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Muscle Dysfunction in Patients With Chronic Obstructive Lung Disease (COPD): the Role of Sympathetic Activation

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