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临床试验/NCT06065033
NCT06065033撤回不适用

Exercise as a Therapeutic for Those Diagnosed With Post-acute Sequelae of Covid-19

University of Virginia2 个研究点 分布在 1 个国家开始时间: 2023年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Left ventricular diastolic function

研究概览

简要总结

The COVID-19 pandemic severely impacted the medical system both directly but also through incomplete recovery from the virus in the form of post-acute sequelae of COVID-19 (PASC). PASC affects at least 9.6 million individuals as of May 2022 and continues to affect many more. PASC is a multisystem disorder often presenting with mental fog, dyspnea on exertion, and fatigue among other symptoms. The etiology of PASC is uncertain but theories include direct cytotoxicity, dysregulated immune responses, endotheliitis associated with microthrombi, eNOS uncoupling, and myocardial fibrosis with impaired ventricular compliance. To date, there are no established treatments. Exercise has the potential as a therapeutic option to improve VO2peak and improve each of the aforementioned underlying etiologies. The investigators plan to examine the effect of High-Intensity Interval Training (HIIT) and Moderate intensity exercise training (MOD) on the symptoms and exercise tolerance of patients with PASC.

The investigators approach will consist of a randomized, blinded, 2-arm, parallel-group design. Enrolled subjects will be randomly assigned to one of two groups in a 1:1 allocation ratio. All groups will undergo a 4-week intervention of 3 days of HIIT per week and 2 days of MOD per week or control of light stretching and controlled breathing. Subjects will be assessed before and after the 4-week intervention to examine the extent to which 4 weeks of the HIIT and MOD combination improves VO2peak and left ventricular diastolic function, global longitudinal strain (GLS), and global circumferential strain (GCS). Further, the investigators will explore changes in markers such as heart rate, heart rhythm, blood pressure, quality of life, exercise tolerance, and PASC symptoms as well as blood/serum markers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessors will be blinded to subject allocation

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-50 years of age
  • Diagnosed with Post Acute Sequelae of COVID-19
  • Physician clearance to undergo exercise training (see section titled cardiorespiratory fitness testing for details; page 6)
  • Complete COVID-19 vaccination status

排除标准

  • Unstable angina or myocardial infarction in the past 4 weeks
  • Uncompensated heart failure
  • NYHA class IV symptoms
  • Complex ventricular arrhythmias
  • Musculoskeletal contraindications to stationary bicycling exercise
  • Symptomatic severe aortic stenosis
  • Acute pulmonary embolus
  • Acute myocarditis
  • Uncontrolled Hypertension as defined as systolic blood pressure > 180 mm Hg or diastolic blood pressure > 120 mm Hg
  • Medication non-compliance
  • Pregnant women-self reported
  • COPD GOLD stage D
  • Malignancy currently actively being treated
  • Uncontrolled Asthma
  • Uncompensated Cirrhosis of the Liver
  • Chronic Kidney disease requiring dialysis therapy
  • Symptomatic Anemia
  • Hemoglobin <7g/dL
  • Poorly controlled diabetes or A1c>9%
  • BMI >35kg/m2
  • Pulmonary Hypertension stage IV
  • Any condition requiring supplemental oxygen
  • Multiple Sclerosis

结局指标

主要结局

Left ventricular diastolic function

时间窗: 4 weeks

Diastolic dysfunction grade measured pre- and post-intervention

VO2peak

时间窗: 4 weeks

Change in VO2peak (L/min) measured pre- and post-intervention

Left ventricular strain

时间窗: 4 weeks

Global longitudinal strain and global circumferential strain measured pre- and post-intervention

次要结局

  • Forced vital capacity (FVC)(4 weeks)
  • C-reactive protein (CRP)(4 weeks)
  • IL-1(4 weeks)
  • TNF-a(4 weeks)
  • Forced expiratory volume in one second (FEV1)(4 weeks)
  • Post COVID-19 Functional Status scale(4 weeks)
  • Fasting glucose(4 weeks)
  • Symptom Burden Questionnaire for Long Covid (SBQ-LC)(4 weeks)
  • Lipids(4 weeks)
  • D-dimer(4 weeks)
  • International Physical Activity Questionnaire (IPAQ)(4 weeks)
  • IL-6(4 weeks)
  • Fibrinogen(4 weeks)
  • NTproBNP(4 weeks)
  • Insulin(4 weeks)
  • Erythrocyte sedimentation rate (ESR)(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Siddartha Angadi

Principal Investigator

University of Virginia

研究点 (2)

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