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Mechanical Unloading for Obesity in Aging
N/A
Recruiting
Led By Tony G Babb, Ph.D.
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No musculoskeletal abnormality that would preclude exercise
Only postmenopausal women will be included
Timeline
Screening 3 weeks
Treatment Varies
Follow Up changesoutcome measures will be assessed within 24-48hrs after completion of each study condition (baseline, control, continuous, and dynamic) between conditions (visits 3-6) compared to baseline between cohorts
Awards & highlights
Study Summary
This trial will study the effects of obesity on lung function, exercise tolerance, & breathlessness in older adults and how mechanical unloading can help.
Who is the study for?
This trial is for healthy older adults aged 65-75 with normal lung function and specific body fat percentages (men: 30-50%, women: 35-55%). Participants should be nonsmokers, without significant mental illness, uncontrolled hypertension, serious health conditions affecting exercise capacity, metabolic disorders like diabetes, or a history of substance abuse. Only postmenopausal women are eligible.Check my eligibility
What is being tested?
The study tests if mechanical unloading of the thorax using an external cuirass can improve lung function and exercise tolerance in obese older adults. It compares respiratory functions and breathlessness during rest and exercise between those with obesity-related respiratory symptoms and those without.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the cuirass device, possible skin irritation at contact points, fatigue due to testing procedures, or shortness of breath when adjusting to assisted ventilation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can exercise without being limited by a physical condition.
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I am a postmenopausal woman.
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My blood pressure is under control.
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I do not have diabetes or any metabolic disorders.
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My body fat percentage is within the required range for my gender.
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I do not have any diagnosed sleep disorders.
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I do not have heart disease or uncontrolled heart symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ changesoutcome measures will be assessed within 24-48hrs after completion of each study condition (baseline, control, continuous, and dynamic) between conditions (visits 3-6) compared to baseline between cohorts
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~changesoutcome measures will be assessed within 24-48hrs after completion of each study condition (baseline, control, continuous, and dynamic) between conditions (visits 3-6) compared to baseline between cohorts
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ASI
Change in Dyspnea on Exertion
Change in Exercise Tolerance - Peak VO2
+9 moreSecondary outcome measures
Changes in FEV1/FVC Ratio
Changes in forced expiratory volume (FEV)
Changes in forced expiratory volume in 1 second (FEV1)
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Interventional ArmExperimental Treatment1 Intervention
Older group of adults (65-75 yrs). Everyone enrolled uses the 'intervention'/ external cuirass - mechanical unloading of thorax
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,727 Total Patients Enrolled
8 Trials studying Aging
436 Patients Enrolled for Aging
Tony G Babb, Ph.D.Principal InvestigatorUT Southwestern Medical Center
2 Previous Clinical Trials
174 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can exercise without being limited by a physical condition.I am a postmenopausal woman.I am not on medications that affect my ability to exercise.I am on hormone replacement therapy and can keep my dosage consistent.My blood pressure is under control.I do not have diabetes or any metabolic disorders.My body fat percentage is within the required range for my gender.I don't have any serious health issues that would stop me from exercising or meeting study goals.I do not have any diagnosed sleep disorders.I am a woman who has not gone through menopause.I do not have heart disease or uncontrolled heart symptoms.I have severe breathlessness.I am between 65-75 years old with healthy lungs.My exercise test showed signs of heart issues or severe breathing problems.
Research Study Groups:
This trial has the following groups:- Group 1: Interventional Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Aging Patient Testimony for trial: Trial Name: NCT05028309 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the eligibility criteria for participation in this trial?
"This medical trial has a criterion for admission that requires potential participants to be aged 65-75 with obesity. It is estimated that 72 individuals will join this clinical research project."
Answered by AI
Is the recruitment process for participants still open?
"Affirmative. Clinicaltrials.gov presents evidence that this trial is currently seeking participants, with a start date of December 1st 2021 and last updated on March 17th 2023. This research requires 72 individuals to be recruited from one site."
Answered by AI
Does this research endeavor include participants aged 40 and older?
"The criteria for joining this experiment requires patients to be between 65 and 75 years old. There are 196 studies that cater to those under 18, while 838 accommodate the elderly population."
Answered by AI
Are there any limitations on the number of individuals involved in this clinical research?
"Affirmative. The details found on clinicaltrials.gov demonstrate that this trial, which was posted as of December 1st 2021, is still in need of participants. 72 subjects are needed from a single site to advance the research."
Answered by AI
What is the aim of this medical trial?
"The principal goal of this medical trial, which will be measured over a specified period, is to quantify results from the Hospital Anxiety and Depression Scale (HADS). Secondary outcomes include changes in Forced Expiratory Volume (FEV), the FEV1/FVC ratio, and alterations in Forced Expiratory Volume in 1 second (FEV1)."
Answered by AI
Who else is applying?
What state do they live in?
Texas
California
What site did they apply to?
Institute for Exercise and Environmental Medicine, UT Southwestern and Texas Health Resources
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
This clinical trial addresses some of the issues I am interested in.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
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