TrialGlobe

Clinical trial

Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation

Recruiting now · Not applicable · 1 countries · Registry ID NCT05880108

Recruiting nowNot applicableInterventional

What this study is about

The research in this VA Merit will examine the effects of obesity and Post-COVID Conditions (PCC) on physical functioning, health-related quality of life, and adipose tissue inflammatory and cellular senescence profiles in older Veterans. Further, it will evaluate whether a weight loss intervention, including dietary modification and exercise, in obese Veterans with and without PCC will reduce systemic and adipose tissue inflammation and senescence and promote PCC recovery.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

AgeNot listed to 80 Years
SexAll
Healthy volunteersAccepted
ConditionPost-COVID Conditions, Obesity

Full registry criteria

Inclusion Criteria: 1. U.S. Veteran 2. Self-reported COVID-19 naïve or COVID-19 \> 90 days ago for lean and obese PCC naïve or documented COVID-19 for the lean and obese PCC groups (At least one PCC symptom \>4 weeks) 3. Body Mass Index: 19-25 or 30-50 kg/m2 Exclusion Criteria: 1. Neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments 2. Active inflammatory, COVID-19, autoimmune, infectious, hepatic (LFTs \> 2.5 x WNL), renal (eGFR\<45), gastrointestinal, malignant, and psychiatric disease 3. Uncontrolled diabetes (HbA1c \>10% or the current use of insulin) 4. Weight change within the past month of \>5 kg 5. Self-reported alcohol or drug abuse 6. Anti-coagulant medication usage

Treatments and study arms

12-weeks of Weight Loss

Behavioral

Participants will be asked to participate in a 1x/week center-based or tele-health nutrition diet class, 2x/week center-based exercise classes, and 1x/week exercise session conducted on their own for \~12 weeks.

12-weeks of Weight Stability

Behavioral

Participants will be asked to participate in a 1x/week center-based or tele-health education class, 2x/week center-based stretching/balance classes, and 1x/week stretching/balance session conducted on their own for \~12 weeks.

Primary outcomes

Cardiorespiratory Fitness (VO2max)Baseline

VO2max (ml/kg/min) comparison between lean PCC naïve, lean with PCC, obese PCC naïve, and obese with PCC

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD🇺🇸 Baltimore, Maryland, United States
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Kristina Marcus, MSContact
Email · Call 410-605-7000
Alice S. Ryan, PhDPrincipal Investigator
South Texas Health Care System, San Antonio, TX🇺🇸 San Antonio, Texas, United States
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Tiffany Cortes, MDContact
Email · Call 814-332-9939
Tim Calderon, MSContact
Email · Call 2106175300