NCT05028309Recruiting
Effects of Obesity in the Aged
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 17 Aug 2021
- Start date
- 1 Dec 2021
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Obesity
- NCT number
- NCT05028309
What you commit to
- Study type: Interventional
- Planned participants: 72
- From 1 Dec 2021 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 65 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute for Exercise and Environmental Medicine, UT Southwestern and Texas Health Resources Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.