RECRUITING

Effects of Obesity in the Aged

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effects of Obesity in the Aged

Quick Facts

Study Start:2021-12-01
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05028309

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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:
  2. * Nonsmokers who have no history of smoking
  3. * No personal history of significant mental illness
  4. * No weight loss dietary restrictions
  5. * No current or past history of significant substance or alcohol abuse
  6. * No history, evidence, or uncontrolled symptoms of heart disease
  7. * No history of uncontrolled hypertension
  8. * No current medications that may interfere with exercise capacity
  9. * No recent history or indication of asthma
  10. * No musculoskeletal abnormality that would preclude exercise
  11. * 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)
  12. * Only postmenopausal women will be included.
  13. * Women on hormone replacement therapy will be allowed to participate if the dosage remains similar during the entire protocol.
  1. * Volunteers with a mMRC score of 3 or 4 will be excluded due to likeliness of underlying disease.
  2. * 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.
  3. * 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).
  4. * Premenopausal women will be excluded.

Contacts and Locations

Study Contact

Research Nurse
CONTACT
214-345-6574
IEEMLung@TexasHealth.org
Abide Abulimiti, Ph.D.
CONTACT
214-345-6501
Abidanabulimiti@TexasHealth.org

Principal Investigator

Tony G Babb, Ph.D.
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center

Study Locations (Sites)

Institute for Exercise and Environmental Medicine, UT Southwestern and Texas Health Resources
Dallas, Texas, 75231
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Tony G Babb, Ph.D., PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-01
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2021-12-01
Study Completion Date2025-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity
  • Aging