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Effects of Obesity in the Aged

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 Years to 75 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how obesity affects breathing, exercise, and shortness of breath during activity in adults ages 65–75, with and without obesity. It also tests whether a device that eases pressure on the chest helps older adults with obesity breathe and exercise better.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 65–75, otherwise healthy, have normal lung function, and be able to do breathing and exercise tests.
  • Have body fat above 30% and up to 50% for men, or above 35% and up to 55% for women.
  • Have never smoked, have no major mental illness history, and have no current or past major drug or alcohol abuse.
  • Have no diet restrictions for weight loss and take no medicines that could affect exercise ability.
  • Have no history or signs of heart disease and no history of uncontrolled high blood pressure.
  • Have no recent asthma or signs of asthma, and no muscle, bone, or joint problem that prevents exercise.
  • Have no serious health problem, past surgery, or chemotherapy that could affect safe participation, breathing, or heart function, as judged by the study team.
  • Women must have gone through menopause. Hormone replacement therapy is allowed if the dose stays about the same throughout the study.

Who can't join

  • A score of 3 or 4 on the mMRC scale, a rating of shortness of breath.
  • Vigorous exercise, such as running, cycling, or swimming, more than three times a week, or exercise ability far above the expected level.
  • Unsafe findings during the exercise bike test, such as signs of heart disease, dangerous heart rhythms, high blood pressure caused by exercise, narrowed airways, or other trouble tolerating exercise.
  • Women who have not yet gone through menopause.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

TX