Effect of Body Position on Spirometry in Abdominal Obesity.



Status:Recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:11/22/2017
Start Date:October 6, 2017
End Date:July 1, 2018

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Objective: Study the effect of body position on spirometry in obese patients as defined by
waist to hip ratio (WHR) of greater than 0.85 in women, and 0.9 in men

Background: Spirometry is routinely ordered to work up dyspnea in obesity. The most common
abnormality is a restrictive disease pattern. The underlying mechanisms of this pattern are
not completely understood. One plausible explanation is diaphragmatic weakness or skeletal
muscle weakness. The change in forced vital capacity (FVC) from sitting to supine is a very
sensitive and specific test for detecting diaphragmatic weakness. The effect of body position
on spirometry in obesity has not been extensively studied, and there are no studies that look
at this when obesity is measured by waist to hip ratio. Effect of body position has been
studied in normal patients, and it is expected the FVC can decrease as much as 10% when
changing from sitting to supine. The investigators do not know what would be considered 'the
normal' amount for FVC to decrease by in the obese population, and thus would like to test
patients with increased WHR both in sitting and supine position. The investigators also want
to do muscle strength test by measuring the maximal inspiratory and expiratory pressures
(MIPs and MEPs).

Anticipated results: the investigators anticipate that our study population will replicate
the restrictive disease pattern usually seen in obesity. The investigators also anticipate
for the FVC to decrease when in the supine position compared to sitting. The amount by which
it decreases will likely fall between 10 -25%. The investigators anticipate to not find any
abnormalities in MIPs and MEPs in obesity.

The design for this study will be a cross-sectional study. This study will be conducted in
the pulmonary function laboratory at Rush University Medical Center. A sample of subjects who
meet the inclusion criteria will be selected from the adult population scheduled for CPFT lab
appointments. The details of the study will be discussed by the respiratory therapist prior
to the end of CPFT study. Information normally gathered in routine CPFTs includes oxygen
saturation, height, and weight. Additional measures for subjects who accept the invitation to
participate in this study will include measurements of BMI, waist circumference, and hip
circumference. Inclusion criteria includes individuals of both genders, age of 18 years or
older and individuals with abdominal obesity as defined by WHO as WHR greater than 0.85 in
women, and 0.90 in men. Exclusion criteria include patients who cannot understand or comply
with the spirometry test, known lung disease, obstructive ventilatory defect on CPFT, chest
wall abnormalities/disorders, known neuromuscular disease, pregnant patients or prisoners.

The BMI (kg/m2) will be calculated as weight (in kilograms) divided by square of the height
(in meters). Waist-hip ratio (WHR) will be measured in the standing position using a
stretch‐resistant tape. Waist circumference will be measured at a midpoint between the lowest
rib and the middle of the iliac crest. The hip is defined as the maximal circumference around
the gluteal muscles below the iliac crests.8,9 These measurements will be obtained by
respiratory therapists who have been trained in obtaining WHR measurements using a
standardized patient to assure measurement fidelity.

Spirometry measurements of FEV1 and FVC will be made in two testing positions for this study;
the patients seated 90o upright (sitting position), and the patient fully supine position (0º
horizontal decubitus position). FVC (forced vital capacity) is the volume of air in liters
that can be forcibly and maximally exhaled after taking in the deepest breath. FEV1 is the
volume of air that can be forcibly exhaled from the lungs in the first second of a forced
expiratory maneuver and is reported in liters. Lung volumes will also be measured in the
sitting position using either body plethysmography or nitrogen washout method as part of the
routine CPFT testing. Maximal inspiratory pressure (MIP) and maximal expiratory pressure
(MEP), will also be measured in the sitting position and reported in centimeters of water (cm
H2O). These reflect the maximum pressures generated by the patient on inhalation and
exhalation, respectively and test respiratory muscle strength. All tests will be conducted in
accordance with 2005 American Thoracic Society/European Respiratory Society guidelines13
using the Sensormedics Vmax pulmonary function system. The Vmax system is calibrated daily
and reports all measurements at body temperature, pressure and water vapor. All tests will be
performed by a team of respiratory therapists who have demonstrated annual competence
following the recommendations of the American Thoracic Society/European Respiratory
Society.14

Individuals who meet the study criteria and are able to successfully complete a CPFT will be
recruited to participate in the study. After completing a consent form, the waist and hip
measurements will be made. MIP and MEP measures will be made in the sitting position. Testing
of spirometry will be repeated in the supine position. Sitting FEV1, FEV1 % predicted, FVC,
FVC % predicted, FEV1/SVC, lower limit of normal for FEV1/FVC, supine FEV1, FEV1 % predicted,
FVC, FVC % predicted, MIP, MEP, ERV, RV, FRC and TLC will be extracted from the pulmonary
function test results and entered in REDCap for data tracking. Age, race, gender, and
diagnosis code will be taken from the information routinely gathered for a pulmonary function
test. The question related to smoking history will be asked directly of the subject. All data
will be entered into REDCap.

Procedures done for research purposes and procedures done for routine clinical management:

A routine complete pulmonary function test (CPFT) as ordered by their referring provider
includes measurements of slow vital capacity by spirometry, forced vital capacity by
spirometry, lung diffusion by DLCO, and measurement of lung volume by body plethysmography.
All of these measurements will be performed while the patient in sitting position. The
additional testing for this study includes spirometry while the patient is in the supine
position; and MIPs, and MEPs in the sitting position.

Inclusion Criteria:

- Individuals of both genders, age of 18 years or older

- Individuals with abdominal obesity with WHR > 0.85 in women, > 0.9 in men

- Ability of patients to transfer themselves into a cardiac chair

- Able to understand and comply with testing instructions

Exclusion Criteria:

- Patients who are less than 18 years old

- Patients who are unable to perform an acceptable and repeatable forced vital capacity

- Airflow limitation as evidenced by sitting FEV1/VC < lower limit of normal

- Patients who have a WHR < 0.85 in women, or < 0.9 in men

- Patients who become lightheaded during sitting spirometry

- Patients who cannot transfer themselves independently to a cardiac chair

- History of lung disease (known obstructive or restrictive lung disease)

- Chest wall abnormalities or kyphoscoliosis

- Neuromuscular disease

- Active hemoptysis or recent angina
We found this trial at
1
site
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Phone: 860-951-9339
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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from
Chicago, IL
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