Effects of Obesity in the Aged

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT05028309
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Mechanical unloading of the Thorax using an external cuirass — OTHER
    External cuirass (i.e., a plastic shell over the thorax) will be used to mechanically unload the chest wall. The cuirass has different operating modes. It can generate a constant negative pressure over the chest wall (e.g., -20cmH2O) or it can be triggered off mouth flow so it can generate a negative pressure on the chest wall during inspiration (e.g., -21cmH2O) and a positive pressure during expiration (e.g., +7cmH2O).

Study Details

The overall objective of this application is to investigate the effects of obesity on lung function, exercise tolerance, and DOE in older obese adults as compared with older adults without obesity, using a novel probe for mechanically unloading the thorax at rest and during exercise. The investigators will use 1) continuous negative cuirass pressure, and 2) assisted biphasic cuirass ventilation to decrease obesity-related effects in older obese adults. Our approach will be to examine respiratory function, exercise tolerance, and DOE with and without mechanical unloading in older obese men and women (65-75 yr), including those with respiratory symptoms (defined by a score of 1 or 2 on the modified Medical Research Council Dyspnea Scale), as compared with older adults without obesity. Specific Aims: The investigators will test the following hypotheses in older adults with and without obesity: Aim 1) Obesity will decrease respiratory function but to a greater extent in older obese adults with respiratory symptoms, (as evidenced by altered pulmonary function and breathing mechanics at rest); Aim 2) Obesity will decrease exercise tolerance (as evidenced by peak V•O2 in ml/min/kg, i.e., physical fitness), but not cardiorespiratory fitness (as evidenced by peak V•O2 in % of predicted based on ideal body wt), except in older obese adults with respiratory symptoms where both may be reduced during graded cycle ergometry. Aim 3) Obesity will increase DOE but to a greater extent in older obese adults with respiratory symptoms as evidenced by increased ratings of perceived breathlessness (sensory \& affective dimensions) during exercise. Aim 4) Mechanical unloading of the thorax will improve respiratory function, submaximal exercise tolerance, and DOE in older obese adults, but to a greater extent in older obese adults with respiratory symptoms.

Key Dates

Start date
Dec 1, 2021
Status verified
Aug 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
72 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Interventional Arm
    Older group of adults (65-75 yrs). Everyone enrolled uses the 'intervention'/ external cuirass - mechanical unloading of thorax

Primary Outcome Measure

Change in Pulmonary Function: Lung Volumes [ Time Frame: Outcome measures will be assessed within 24-48hrs after completion of each study condition (baseline, control, continuous, and dynamic) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Institute for Exercise and Environmental Medicine, UT Southwestern and Texas Health ResourcesDallasTexas75231
Raksa Moran, BSN
[email protected]
214-345-6574

Find similar trials in Dallas, TX

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Institute for Exercise and Environmental Medicine, UT Southwestern and Texas Health Resources· Dallas, TX

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