Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation

Not Applicable

Recruiting

• Conditions: Obesity; Post-COVID Conditions

• 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.

Study Timeline

• Study First Submitted: 2023-05-25
• Study First Submitted QC: 2023-05-25
• Study First Posted: 2023-05-30
• Study Start: 2024-06-03
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-25
• Last Update Posted: 2025-06-29
• Primary Completion: 2028-09-30
• Study Completion: 2028-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD; 🇺🇸 Baltimore, Maryland, United States

South Texas Health Care System, San Antonio, TX; 🇺🇸 San Antonio, Texas, United States