Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Cardiorespiratory Fitness (VO2max)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to treatment allocation/group assignment
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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 approximately 12 weeks.
干预措施: 12-weeks of Weight Loss (Behavioral)
Weight Stability
Participants will be asked to participate in a 1x/week center-based or tele-health education class, 2x/week center-based or tele-health stretching/balance classes, and 1x/week stretching/balance session conducted on their own for approximately 12 weeks.
干预措施: 12-weeks of Weight Stability (Behavioral)
结局指标
主要结局
Cardiorespiratory Fitness (VO2max)
时间窗: Baseline
VO2max (ml/kg/min) comparison between lean PCC naïve, lean with PCC, obese PCC naïve, and obese with PCC
次要结局
- Change in Cardiorespiratory Fitness (VO2max)(Baseline, After 12 weeks of Weight Loss)
- Change in adipose tissue cellular senescence(Baseline, After 12 weeks of Weight Loss)