Taking people in United StatesNo phase

Tests a chest device in older adults with and without obesity

Tests a chest-unloading device at rest and during exercise in older adults with obesity.

Key facts

Who runs it: University of Texas Southwestern Medical Center
Where: Dallas, United StatesSee the site
Trial code: NCT05028309
Registry title: Effects of Obesity in the Aged
Status: Recruiting
People taking part: 72 people, planned
Started: 1 Dec 2021
Expected to end: 31 Dec 2026
Type of study: Interventional
Treatments tested: Mechanical unloading of the Thorax using an external cuirass
Record updated: 2 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for otherwise healthy adults aged 65 to 75, with and without obesity, to study how obesity affects breathing and exercise.

Age: 65 to 75 years
Sex: Men and women can join. Women must be past menopause.
Disease stage: Normal lung function. Men need a body fat above 30% and up to 50%; women above 35% and up to 55% (older adults without obesity are also studied).
Earlier treatment: No weight loss diet restrictions. No medicines that may interfere with exercise capacity.

Main reasons for not taking part

Current or past smoking
Heart disease or uncontrolled high blood pressure
Asthma or a recent history of asthma
Breathlessness score (mMRC) of 3 or 4
Regular vigorous exercise more than three times per week

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

Otherwise healthy older adults 65-75 years of age with normal lung function; men 30< %body fat ≤50 and women 35< %body fat ≤55; and ability to perform pulmonary and exercise test. Other inclusion criteria include the following:
Nonsmokers who have no history of smoking
No personal history of significant mental illness
No weight loss dietary restrictions
No current or past history of significant substance or alcohol abuse
No history, evidence, or uncontrolled symptoms of heart disease
No history of uncontrolled hypertension
No current medications that may interfere with exercise capacity
No recent history or indication of asthma
No musculoskeletal abnormality that would preclude exercise
No serious health conditions that would preclude study goals or participation in exercise (per PI \& medical staff \& preliminary or follow up testing; including significant other diseases, occult asthma, prior surgeries-especial lung or abdominal, or history of chemotherapy that could affect lung or heart function)
Only postmenopausal women will be included
Women on hormone replacement therapy will be allowed to participate if the dosage remains similar during the entire protocol

Who cannot take part

Volunteers with a mMRC score of 3 or 4 will be excluded due to likeliness of underlying disease
Maximal cycle ergometry test will be used to determine if further participation in testing is appropriate for the participant (e.g., normal exercise test, exclude presence of provokable ECG changes suggestive of heart disease, or dangerous arrhythmias or exercise induced hypertension or bronchoconstriction. If the participant develops an abnormal ECG or shows other signs of exercise intolerance or if signs of cardiovascular disease are noted during the exercise test, it will be terminated and the participant will be referred to their personal physician for further evaluation (see DMSP)
Individuals participating in regular vigorous conditioning exercise such as running, jogging, aerobics, cycling, or swimming more than three times per week will be excluded. However, if subjects have an exceedingly high exercise capacity (greater than 2 SD of predicted), they will be excluded
Premenopausal women will be excluded

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 65 and 75 years old?

Where in United States

Institute for Exercise and Environmental Medicine, UT Southwestern and Texas Health ResourcesDallas, United StatesContact: Raksa Moran, BSNTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

Interventional ArmTreatment being tested
Older group of adults (65-75 yrs). Everyone enrolled uses the 'intervention'/ external cuirass - mechanical unloading of thorax
Treatment: Mechanical unloading of the Thorax using an external cuirass