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Effects of Obesity in the Aged

This study is looking at how obesity affects lung function and exercise ability in older adults. Researchers will use an external cuirass (a plastic shell worn over the chest) to mechanically unload your chest wall. This device has different settings, including continuous negative pressure and assisted biphasic ventilation, to see if it can help reduce obesity-related issues. The study aims to understand if these interventions improve lung function, how well you can exercise (exercise tolerance), and shortness of breath during activity (dyspnea on exertion). You might be able to join if you are an otherwise healthy adult between 65 and 75 years old with obesity, normal lung function, and no history of smoking or significant mental illness. The current status of this study is unclear.

Study design
This interventional study plans to enroll 72 participants. It will compare different operating modes of the external cuirass.
What's involved
Outcome measures will be assessed within 24-48 hours after completing each study condition (baseline, control, continuous, and dynamic).
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05028309

Effects of Obesity in the Aged

Recruiting
NAAges 65–75Interventional
University of Texas Southwestern Medical Center
~72 participants
Updated 2026-09-02 on ClinicalTrials.gov
What's tested:Mechanical unloading of the Thorax using an external cuirass

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Pulmonary Function: Lung Volumes
Measured over Outcome measures will be assessed within 24-48hrs after completion of each study condition (baseline, control, continuous, and dynamic)
+11 more outcomes measured

Conditions

Obesity
Aging

Explore related trials

AgingObesity

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Tony G Babb, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Research Nurse
[email protected]
214-345-6574
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in Pulmonary Function: Lung VolumesOutcome measures will be assessed within 24-48hrs after completion of each study condition (baseline, control, continuous, and dynamic)

    Pulmonary function is comprised of several physiological variables but this study will primarily measure Lung Volume: FRC (liters) and TLC (liters)

  • Change in Exercise Tolerance - Peak VO2Outcome measures will be assessed within 24-48hrs after completion of each study condition (baseline, control, continuous, and dynamic).

    Exercise Tolerance is represented by several physiological variables but the primary variable is Maximal oxygen uptake (L/min and percent predicted)

  • Change in Dyspnea on ExertionOutcome measures will be assessed within 24-48hrs after completion of each study condition (baseline, control, continuous, and dynamic).

    Dyspnea on Exertion is represented using the Borg Scale which provides Ratings of Perceived Breathlessness (RPB) during constant load exercise cycling. The Borg Scale measures from 0-10, where 0 = no breathlessness and 10 = maximal breathlessness.

  • Changes in PANAS QuestionnaireOutcome measures will be assessed within 24-48hrs after completion of each study condition (baseline, control, continuous, and dynamic).

    Positive and Negative Affect Schedule. This scale consists of a number of words that describe different feelings and emotions.

  • Modified Medical Research Council Dyspnea Scale (mMRC Dyspnea Scale)Outcome measures will be assessed immediately after completion of mMRC questionnaire (during study visit 2)

    Investigate the qualities of respiratory sensations (e.g., "effort of breathing", "breathing heavy", "breathing shallow") during exercise before and after mechanical unloading of the chest wall

  • Dyspnoea-12Outcome measures will be assessed immediately after completion of Dyspnoea-12 questionnaire (during study visit 2)

    This questionnaire is designed to help us learn more about how their breathing is troubling them.

  • ASIOutcome measures will be assessed immediately after completion of ASI questionnaire (during study visit 2)

    The Anxiety Sensitivity Index (ASI) is a 16 item scale containing items specifying different concerns someone could have regarding their anxiety.

  • HADSOutcome measures will be assessed immediately after completion of HADS questionnaire (during study visit 2)

    HADS (Hospital Anxiety and Depression Scale) aims to measure symptoms of anxiety (HADS Anxiety) and depression (HADS Depression). HADS score: 0-7 = normal; 8-10 = mild; 11-14 = moderate; 15-21 = severe

  • SDS-MCOutcome measures will be assessed immediately after completion of MC-SDS questionnaire (during study visit 2)

    The Marlowe-Crowne Social Desirability Scale (MC-SDS) is a 33-item self-report questionnaire that assesses whether or not respondents are concerned with social approval.

  • IPAQOutcome measures will be assessed immediately after completion of IPAQ questionnaire (during study visit 2)

    International Physical Activity Questionnaires (IPAQ) is a 27-item self-reported measure of physical activity

  • WSQOutcome measures will be assessed immediately after completion of WSQ questionnaire (during study visit 2)

    Workforce Sitting Questionnaire (WSQ) is to estimate how much time they usually spend sitting in each of the following activities on a working day and a non-working day.

  • SF-12Outcome measures will be assessed immediately after completion of SF-12 questionnaire (during study visit 2)

    SF-12 is a health-related quality-of-life questionnaire