Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation
- Conditions
- ObesityPost-COVID Conditions
- Interventions
- Behavioral: 12-weeks of Weight LossBehavioral: 12-weeks of Weight Stability
- Registration Number
- NCT05880108
- Lead Sponsor
- VA Office of Research and Development
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- U.S. Veteran
- No Post-COVID symptoms or at least one Post-COVID symptom lasting >4 weeks
- Body Mass Index: 19-25 or 30-40 kg/m2
- Postmenopausal status for women
- Neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments
- Active inflammatory, COVID-19, autoimmune, infectious, hepatic (LFTs > 2.5 x WNL), renal (eGFR<45), gastrointestinal, malignant, and psychiatric disease
- Uncontrolled diabetes (HbA1c >10% or the current use of insulin)
- Weight change within the past month of >5 kg
- History of keloid formation
- Self-reported alcohol or drug abuse
- Anti-coagulant medication usage
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Weight Loss 12-weeks of Weight Loss Participants will be asked to participate in a 1x/week center-based nutrition diet class, 2x/week center-based exercise classes, and 1x/week exercise session conducted on their own for 12 weeks. Weight Stability 12-weeks of Weight Stability Participants will be asked to participate in a 1x/week center-based health education class, 2x/week center-based stretching/balance classes, and 1x/week stretching/balance session conducted on their own for 12 weeks.
- Primary Outcome Measures
Name Time Method Cardiorespiratory Fitness (VO2max) Baseline VO2max (ml/kg/min) comparison between lean PCC naïve, lean with PCC, obese PCC naïve, and obese with PCC
- Secondary Outcome Measures
Name Time Method Change in Cardiorespiratory Fitness (VO2max) Baseline, After 12 weeks of Weight Loss Change in VO2max (L/min)
Change in adipose tissue cellular senescence Baseline, After 12 weeks of Weight Loss Change in adipose tissue chemokine (C-C motif) ligand 3 (CCL3)
Trial Locations
- Locations (2)
South Texas Health Care System, San Antonio, TX
🇺🇸San Antonio, Texas, United States
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
🇺🇸Baltimore, Maryland, United States