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Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation

NCT05880108 · VA Office of Research and Development
In plain English

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About this study
Findings of post-acute sequelae of Post-COVID Conditions (PCC) manifestations of fatigue, pain, dyspnea, and muscle weakness, provide a strong rationale for rehabilitation; yet few formal studies exist and the effects of severe acute respiratory syndrome coronavirus-2 infection on function are not well described. Notably, two-thirds of Veterans are overweight and obese, rendering excess adiposity a significant risk factor and a high-priority area related to PCC prevention and care. Obesity increases the risk of severe illness in Veterans recovering from PCC, but how it does so is not fully understood. Recent research suggests that excess adipose tissue is associated with adverse changes in adipose cellular function, and that these variations may be involved in the biology of aging and the etiology of aging-related diseases. Adipose tissue contains cells that have undergone cellular senescence, which induces inflammation, cytotoxicity, and metabolic dysfunction in other cells and tissues. However, the precise role of adipose tissue cellular composition on PCC recovery is limited. Thus, the investigators propose to evaluate the role of obesity and PCC on physical functioning, health-related quality of life (HRQOL), and systemic and adipose tissue inflammatory and cellular senescence profiles in ethnically diverse older Veterans from the Audie Murphy (San Antonio) and Baltimore VA Medical Centers. Further, the investigators propose a randomized controlled trial to determine whether a reduction in body weight and increased physical function by a weight loss intervention (WL), including dietary modification and exercise, in obese Veterans with PCC will reduce systemic and adipose tissue inflammation and senescence, which will have important implications for PCC recovery.
Eligibility 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
Study design
Enrollment target: 150 participants
Allocation: randomized
Masking: single
Age groups: child, adult, older_adult
Timeline
Starts: 2024-06-03
Estimated completion: 2028-09-30
Last updated: 2025-06-29
Interventions
Behavioral: 12-weeks of Weight LossBehavioral: 12-weeks of Weight Stability
Primary outcomes
  • Cardiorespiratory Fitness (VO2max) (Baseline)
Sponsor
VA Office of Research and Development · fed
With: Baltimore VA Medical Center, South Texas Veterans Health Care System
Contacts & investigators
ContactKristina Marcus, MS · contact · kristina.marcus@va.gov · (410) 605-7000
InvestigatorAlice S. Ryan, PhD · principal_investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
All locations (2)
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MDRecruiting
Baltimore, Maryland, United States
South Texas Health Care System, San Antonio, TXRecruiting
San Antonio, Texas, United States
Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation · TrialPath