The Effects of a Multi-factorial Rehabilitation Program for Healthcare Workers Suffering From Post-COVID-19 Fatigue Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change of maximum oxygen uptake (VO2max) over time-points (baseline - 4 weeks - 8 weeks) assessed during cardio-pulmonary exercise testing (CPET)
研究概览
简要总结
The SARS-CoV2 pandemic has kept the world in suspense for over a year now. Almost 100 million people around the world have contracted COVID-19 to date and over 2 million people have died of COVID-19 by the end of January 2021.
Despite the tragedy of these deaths, it must be pointed out at this point that the number of COVID-19 survivors is significantly larger. These COVID-19 survivors are now the focus of interest in rehabilitation measures, as it has been shown that survival of the disease does not go hand in hand with a complete cure. Thirty-five percent of all COVID-19 survivors and 87% of the COVID-19 survivors who were hospitalized in the course of their illness suffer from after-effects that are currently summarized as post-COVID fatigue syndrome also known as "Long-COVID".
As health care workers are at higher risk of contracting SARS CoV2 and furthermore, considering their central role in the overcoming of this pandemic, a COVID-19 rehabilitation program for healthcare workers of the Medical University of Vienna, Austria as well as the General Hospital of Vienna, Austria - together the second-largest university-clinic in the world - was developed as part of workplace health promotion. Nowadays, the fatigue syndrome is primarily known as a side effect of cancer treatment and thus from the rehabilitation of cancer patients. Cancer-related fatigue is a massive limiting side effect for patients and the currently most effective treatment strategy against cancer-associated fatigue syndrome is physical training.
The idea for this current project is, that physical exercise might have similar effects on post-SARS-CoV2 fatigue as it has on cancer-related fatigue.
The current study evaluates the effects of this primarily exercise-based rehabilitation program on Long-COVID fatigue.
详细描述
Employees of the Medical University of Vienna, Austria and the General Hospital of Vienna, Austria who survived a SARS-CoV2 infection will be invited to take part in an eight weeks post-COVID-19 rehabilitation program which is part of a workplace health promotion measure. This program consists of eight weeks of exercising (twice per week supervised resistance training + individual, heart-rate controlled endurance training recommendations) with a sports scientist and a sports medicine specialist, complemented by one session of nutrition consultation with a nutritionist and two sessions of psychological consultation with a clinical psychologist.
Parallel to this workplace health promotion program, the scientific evaluation of this intevention will be undertaken via this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Employees of the Medical University of Vienna, Austria or the General Hospital of Vienna, Austria
- •survived COVID-19 infection
排除标准
- •acute COVID-19 infection
- •serious, uncontrolled diseases of the cardiovascular system
- •insufficient language skills to complete the study requirements
研究组 & 干预措施
Post COVID-19 fatigue at baseline "yes"
SARS-CoV2 survivor who attends the exercise program and suffers from post-COVID-19 fatigue Syndrome according to the Post-Covid-19-Functional Scale (PCFS)
干预措施: Exercise (Other)
Post COVID-19 fatigue at baseline "no"
SARS-CoV2 survivor who attends the exercise program and doesn't suffer from post-COVID-19 fatigue Syndrome according to the Post-Covid-19-Functional Scale (PCFS)
干预措施: Exercise (Other)
结局指标
主要结局
Change of maximum oxygen uptake (VO2max) over time-points (baseline - 4 weeks - 8 weeks) assessed during cardio-pulmonary exercise testing (CPET)
时间窗: Baseline, 4 weeks, 8 weeks
Measurement of VO2max during an exhaustive CPET is the gold standard for objectifying cardiopulmonary performance and detecting any cardiovascular risks under stress. VO2max will be measured in ml/kg bodyweight.This examination is the gold standard for objectifying cardiopulmonary performance and detecting any cardiovascular risks under stress.
次要结局
- Change of BNP over time-points (baseline - 4 weeks - 8 weeks) via blood sample.(Baseline, 4 weeks, 8 weeks)
- Change of work ability over time-points (baseline, 4 weeks, 8 weeks) via Work Ability Index (WAI) questionnaire.(Baseline, 4 weeks, 8 weeks)
- Change of Mild Cognitive Impairment over time-points (baseline, 8 weeks) via Montreal Cognitive Assessment (MoCA)(Baseline, 8 weeks)
- Change of sleep quality over time points (baseline, 4 weeks, 8 weeks) via Insomnia Severity Index (ISI)(Baseline, 4 weeks, 8 weeks)
- Change of troponin (TnT) over time-points (baseline - 4 weeks - 8 weeks) via blood sample.(Baseline, 4 weeks, 8 weeks)
- Change of triglycerides over time-points (baseline - 4 weeks - 8 weeks) via blood sample.(Baseline, 4 weeks, 8 weeks)
- Change of distance walked in meters per day over time(From the first exercise session over 8 weeks until the last exercise session (daily))
- Change of time of physical activity per day in minutes over time(From the first exercise session over 8 weeks until the last exercise session (daily))
- Change of step count per day over time(From the first exercise session over 8 weeks until the last exercise session (daily))
- Change of average heart rate per day over time(From the first exercise session over 8 weeks until the last exercise session (daily))
- Change of walking distance during a six minutes walk test (6MWT) over time-points (baseline - 4 weeks - 8 weeks)(Baseline, 4 weeks, 8 weeks)
- Change of numbers over time-points (baseline - 4 weeks - 8 weeks) how often someone can stand up and sit down on a chair within 30 seconds during a 30-seconds sit-to-stand test (30secSTS)(Baseline, 4 weeks, 8 weeks)
- Change of absolute body fat over time-points (baseline - 4 weeks - 8 weeks) via Bioelectrical Impedance Analysis (BiA)(Baseline, 4 weeks, 8 weeks)
- Change of body fat percentage over time-points (baseline - 4 weeks - 8 weeks) via Bioelectrical Impedance Analysis (BiA)(Baseline, 4 weeks, 8 weeks)
- Change of absolute Lean Body Mass (LBM) over time-points (baseline - 4 weeks - 8 weeks) via Bioelectrical Impedance Analysis (BiA)(Baseline, 4 weeks, 8 weeks)
- Change of maximum heart rate per day over time(From the first exercise session over 8 weeks until the last exercise session (daily))
- Change of average oxygen saturation (in %) per day over time(From the first exercise session over 8 weeks until the last exercise session (daily))
- Change of CK-MB over time-points (baseline - 4 weeks - 8 weeks) via blood sample.(Baseline, 4 weeks, 8 weeks)
- Change of HS-CRP over time-points (baseline - 4 weeks - 8 weeks) via blood sample.(Baseline, 4 weeks, 8 weeks)
- Change of IL-6 over time-points (baseline - 4 weeks - 8 weeks) via blood sample.(Baseline, 4 weeks, 8 weeks)
- Change of cholesterol over time-points (baseline - 4 weeks - 8 weeks) via blood sample.(Baseline, 4 weeks, 8 weeks)
- Change of realtive Lean Body Mass (LBM) over time-points (baseline - 4 weeks - 8 weeks) via Bioelectrical Impedance Analysis (BiA)(Baseline, 4 weeks, 8 weeks)
- Change of generalized anxiety measured over time-points (baseline - 4 weeks - 8 weeks) via Generalized Anxiety Disorder Scale-7 (GAD-7)(Baseline, 4 weeks, 8 weeks)
- Change of depression measured over time-points (baseline - 4 weeks - 8 weeks) via the Patient Health Questionnaire-9 (PHQ-9)(Baseline, 4 weeks, 8 weeks)
- Change of mental stress measured over time-points (baseline - 4 weeks - 8 weeks) via Perceived Stress Scale (PSS-10)(Baseline, 4 weeks, 8 weeks)
- Change of fatigue measured over time-points (baseline - 4 weeks - 8 weeks) via Brief Fatigue Inventory (BFI)(Baseline, 4 weeks, 8 weeks)
- Change of resilience measured over time-points (baseline - 4 weeks - 8 weeks) via Brief Resilience Scale (BRS)(Baseline, 4 weeks, 8 weeks)
- Change and time kinetics of handgrip strength (HGS) over time-points (baseline and before each exercise session) measured via handgrip Dynamometer.(Baseline, and before every supervised resistance exercise session)
- Change and time kinetics of physical and functional limitations of COVID-19 survivors over time-points (baseline and before each exercise session) via Post-Covid-19-Functional Scale (PCFS)(Baseline, and before every supervised resistance exercise session)
研究者
Richard Crevenna
Univ.-Prof. Dr. MBA MMSc, Head of Department of Physical Medicine, Rehabilitation and Occupational Medicine
Medical University of Vienna