Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation
Purpose
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.
Conditions
- Post-COVID Conditions
- Obesity
Eligibility
- Eligible Ages
- Between 55 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- U.S. Veteran 2. No Post-COVID symptoms or at least one Post-COVID symptom lasting >4 weeks 3. Body Mass Index: 19-25 or 30-40 kg/m2 4. Postmenopausal status for women
Exclusion Criteria
- 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. History of keloid formation 6. Self-reported alcohol or drug abuse 7. Anti-coagulant medication usage
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Weight Loss Program (Diet and Exercise)
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Outcome assessors will be blinded to treatment allocation/group assignment
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
|
Active Comparator 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. |
|
Recruiting Locations
More Details
- NCT ID
- NCT05880108
- Status
- Not yet recruiting
- Sponsor
- VA Office of Research and Development
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.