Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 12-weeks of Weight Loss, 12-weeks of Weight Stability.
- Who it may be relevant to
- Registry conditions: Post-COVID Conditions, Obesity. Basic parameters: up to 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral 12-weeks of Weight Loss
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. - Behavioral 12-weeks of Weight Stability
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 outcome measures
- Cardiorespiratory Fitness (VO2max) [Time frame: Baseline]
Secondary outcome measures (2)
- Change in Cardiorespiratory Fitness (VO2max) [Time frame: Baseline, After 12 weeks of Weight Loss]
- Change in adipose tissue cellular senescence [Time frame: Baseline, After 12 weeks of Weight Loss]
Eligibility criteria
Inclusion criteria
- U.S. Veteran
- 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)
- Body Mass Index: 19-25 or 30-50 kg/m2
Exclusion criteria
- 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
- Self-reported alcohol or drug abuse
- Anti-coagulant medication usage
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore
- South Texas Health Care System, San Antonio, TX — San Antonio
Identifiers
NCT: NCT05880108 · F4572-R · 1I01RX004572-01A1