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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01505543
Other study ID # 2012_SBrumagne_COPD
Secondary ID 1.5.104.03, G.06
Status Completed
Phase N/A
First received January 4, 2012
Last updated December 4, 2013
Start date January 2012
Est. completion date September 2012

Study information

Verified date July 2012
Source Katholieke Universiteit Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Observational

Clinical Trial Summary

Proprioceptive weighting changes may explain differences in postural control performance. In addition, the respiratory movement has a disturbing effect on postural balance. Postural balance seems to be impaired in individuals with respiratory disorders. Increased risk of falling is reported in individuals with chronic obstructive pulmonary disease. Besides the essential role of respiration, the diaphragm may also play an important role in the control of the trunk and postural balance.

The aim of the study is to clarify whether proprioceptive postural control is impaired in individuals with chronic obstructive pulmonary disease.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 2012
Est. primary completion date August 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria individuals with chronic obstructive pulmonary disease:

- Age: 40-80 years old

- Spirometry (post-bronchodilator) based diagnosis of COPD (GOLD criteria)

- Willingness to sign the informed consent

Inclusion Criteria healthy controls:

- Age: 40-80 years old

- No COPD (spirometry based: FEV1/FVC = 0.7 and FEV1 > 80%)

- Willingness to sign the informed consent

Exclusion Criteria:

- History of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant

- One of the following conditions: Parkinson, multiple sclerosis, stroke, history of vestibular disorder

- Respiratory disorder other than COPD

- a1-antitrypsin deficiency

- Known history of significant inflammatory disease other than COPD

- COPD exacerbation within 4 weeks prior to study

- Lung surgery

- Recent diagnosis of cancer

- Therapy with oral corticosteroids in the last 6 weeks

- Significant cardiovascular comorbidity

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Belgium Katholieke Universiteit Leuven Leuven Vlaams-Brabant

Sponsors (2)

Lead Sponsor Collaborator
Katholieke Universiteit Leuven Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Janssens L, Brumagne S, Polspoel K, Troosters T, McConnell A. The effect of inspiratory muscles fatigue on postural control in people with and without recurrent low back pain. Spine (Phila Pa 1976). 2010 May 1;35(10):1088-94. doi: 10.1097/BRS.0b013e3181bee5c3. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Proprioceptive postural control Center of pressure displacement (force plate) in standing in response to local muscle vibration on ankle and back muscles to specifically detect the role of proprioception in postural control. 6 months No
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