A plastic shell on the chest may help older adults with obesity breathe easier

NCT ID NCT05028309

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This study tests whether a device called an external cuirass, a plastic shell worn over the chest, can reduce the extra effort of breathing that often comes with obesity in older age. Researchers will compare older adults with and without obesity, aged 65 to 75, measuring lung function, exercise tolerance, and breathlessness at rest and during cycling. Some participants will use the cuirass to gently unload the chest wall, and the team will see if that improves breathing and comfort.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
External cuirass, a plastic shell worn over the chest that applies gentle pressure to help with breathing
What this could lead to
If it works, this could point toward a non-drug way to help older adults with obesity breathe easier and exercise more comfortably.
What could go wrong
This is an early, small study, so results may not apply to everyone. The chest shell may feel awkward or cause discomfort, and it is not yet known if it will meaningfully improve daily life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * Volunteers with a mMRC score of 3 or 4 will be excluded due to likeliness of underlying disease. * 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. * 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). * Premenopausal women will be excluded.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Institute for Exercise and Environmental Medicine, UT Southwestern and Texas Health Resources

    RECRUITING

    Dallas, Texas, 75231, United States

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