Clinical trial NCT04841759: The Effects of a Multi-factorial Rehabilitation Program for Healthcare Workers Suffering From Post-COVID-19 Fatigue Syndrome
Official title: The Effects of a Multi-factorial Rehabilitation Program for Healthcare Workers Suffering From Post-COVID-19 Fatigue Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Long-COVID
SARS-CoV fatigue syndrome
Exercise
Rehabilitation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stratification regarding post-COVID-19 fatigue syndrome at baseline yes/no
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Employees of the Medical University of Vienna, Austria or the General Hospital of Vienna, Austria
* survived COVID-19 infection

Exclusion Criteria:

* acute COVID-19 infection
* serious, uncontrolled diseases of the cardiovascular system
* insufficient language skills to complete the study requirements

Primary outcomes:
measure: Change of maximum oxygen uptake (VO2max) over time-points (baseline - 4 weeks - 8 weeks) assessed during cardio-pulmonary exercise testing (CPET)
timeFrame: Baseline, 4 weeks, 8 weeks
Secondary outcomes:
measure: Change of walking distance during a six minutes walk test (6MWT) over time-points (baseline - 4 weeks - 8 weeks)
timeFrame: Baseline, 4 weeks, 8 weeks
measure: 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)
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change of absolute body fat over time-points (baseline - 4 weeks - 8 weeks) via Bioelectrical Impedance Analysis (BiA)
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change of body fat percentage over time-points (baseline - 4 weeks - 8 weeks) via Bioelectrical Impedance Analysis (BiA)
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change of absolute Lean Body Mass (LBM) over time-points (baseline - 4 weeks - 8 weeks) via Bioelectrical Impedance Analysis (BiA)
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change of realtive Lean Body Mass (LBM) over time-points (baseline - 4 weeks - 8 weeks) via Bioelectrical Impedance Analysis (BiA)
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change of generalized anxiety measured over time-points (baseline - 4 weeks - 8 weeks) via Generalized Anxiety Disorder Scale-7 (GAD-7)
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change of depression measured over time-points (baseline - 4 weeks - 8 weeks) via the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change of mental stress measured over time-points (baseline - 4 weeks - 8 weeks) via Perceived Stress Scale (PSS-10)
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change of fatigue measured over time-points (baseline - 4 weeks - 8 weeks) via Brief Fatigue Inventory (BFI)
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change of resilience measured over time-points (baseline - 4 weeks - 8 weeks) via Brief Resilience Scale (BRS)
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change and time kinetics of handgrip strength (HGS) over time-points (baseline and before each exercise session) measured via handgrip Dynamometer.
timeFrame: Baseline, and before every supervised resistance exercise session
measure: 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)
timeFrame: Baseline, and before every supervised resistance exercise session
measure: Change of work ability over time-points (baseline, 4 weeks, 8 weeks) via Work Ability Index (WAI) questionnaire.
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change of troponin (TnT) over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change of BNP over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change of CK-MB over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change of HS-CRP over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change of IL-6 over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change of cholesterol over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change of triglycerides over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change of distance walked in meters per day over time
timeFrame: From the first exercise session over 8 weeks until the last exercise session (daily)
measure: Change of time of physical activity per day in minutes over time
timeFrame: From the first exercise session over 8 weeks until the last exercise session (daily)
measure: Change of step count per day over time
timeFrame: From the first exercise session over 8 weeks until the last exercise session (daily)
measure: Change of average heart rate per day over time
timeFrame: From the first exercise session over 8 weeks until the last exercise session (daily)
measure: Change of maximum heart rate per day over time
timeFrame: From the first exercise session over 8 weeks until the last exercise session (daily)
measure: Change of average oxygen saturation (in %) per day over time
timeFrame: From the first exercise session over 8 weeks until the last exercise session (daily)
measure: Change of Mild Cognitive Impairment over time-points (baseline, 8 weeks) via Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, 8 weeks
measure: Change of sleep quality over time points (baseline, 4 weeks, 8 weeks) via Insomnia Severity Index (ISI)
timeFrame: Baseline, 4 weeks, 8 weeks
Other outcomes:
measure: Status of bone resorption at baseline
timeFrame: Baseline only
measure: Status of bone formation at baseline
timeFrame: Baseline only
measure: Status of bone turnover at baseline
timeFrame: Baseline only
measure: Status of bone mineralization at baseline
timeFrame: Baseline only
measure: Status of calcium metabolism at baseline
timeFrame: Baseline only
measure: Status of serum calcium concentration regulation at baseline
timeFrame: Baseline only
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
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