Effect of Body Position on Spirometry in Abdominal Obesity.

NCT03347604 | Completed

• 1 other identifier: ORA: 17060206-IRB01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity, Abdominal

Outcome Measures

Primary Outcomes (7)

• Forced expiratory volume in 1 second (FEV1, unit is Liters)

  Investigators will measure FEV1 for patient in ight position.

  first and only visit in study

• Forced vital capacity (FVC , unit is Liters)

  Investigators with measure FVC in upright position.

  first and only visit in study

• Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC)

  Ratio of FEV1/FVC in supine position.

  first and only visit in study

• Total lung capacity (TLC, unit is Liters).

  Investigators will measure TLC in upright position.

  first and only visit in study

• Maximum inspiratory pressure (MIP, unit is cm of water).

  Investigators will measure MIP in upright position.

  first and only visit in study

• Maximum expiratory pressure (MEP, unit is cm of water).

  Investigators will measure MEP in upright position.

  first and only visit in study

• Forced vital capacity (FVC , unit is L)

  Does supine position decrease forced vital capacity in abdominal obese ? Investigators will measure FVC in supine/lying down position.

  first and only visit in study

Study Arms (1)

Patients with abdominal obesity

Enrolling patients with abdominal obesity as defined by WHO to have waist to hop ratio of \> 0.85 in women, or \> 0.9 in men.

Diagnostic Test: Supine spirometry, MIPs and MEPs

Interventions

Supine spirometry, MIPs and MEPs DIAGNOSTIC_TEST

We are going to test spirometry while in supine position , and also test respiratory muscles by measuring the maximum inspiratory and maximum expiratory efforts made by patients.

Patients with abdominal obesity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population is 30 medically stable obese patients with WHR \> 0.85 in women, or \> 0.9 in men, coming to outpatient clinic at Rush University Medical Center for complete pulmonary function testing.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (26)

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MeSH Terms

Conditions

Obesity, Abdominal

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 20, 2017
• Study Start: October 6, 2017
• Primary Completion: August 30, 2018
• Study Completion: December 30, 2018
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

US (1)