Investigating how obesity affects lung function in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to explore the impact of obesity on lung function, exercise tolerance, and dyspnea on exertion (DOE) in older adults aged 65-75, comparing those with obesity to those without. The researchers will utilize innovative techniques such as continuous negative cuirass pressure and assisted biphasic cuirass ventilation to mechanically unload the thorax during rest and exercise. By examining respiratory function and exercise capacity, the study seeks to clarify how obesity-related respiratory issues affect older adults, particularly those experiencing respiratory symptoms. The findings could lead to better understanding and management of exercise intolerance in this population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institute for Exercise and Environmental Medicine, UT Southwestern and Texas Health Resources
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Tony G Babb, Ph.D. — University of Texas Southwestern Medical Center
• Study coordinator: Research Nurse
• Email: IEEMLung@TexasHealth.org
• Phone: 214-345-6574

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.