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The Effects of a Multi-factorial Rehabilitation Program for Healthcare Workers Suffering From Post-COVID-19 Fatigue Syndrome

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Exercise
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COVID-19 focused on measuring Long-COVID, SARS-CoV fatigue syndrome, Exercise, Rehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Post COVID-19 fatigue at baseline "yes"

Post COVID-19 fatigue at baseline "no"

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Change of maximum oxygen uptake (VO2max) over time-points (baseline - 4 weeks - 8 weeks) assessed during cardio-pulmonary exercise testing (CPET)
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.

Secondary Outcome Measures

Change of walking distance during a six minutes walk test (6MWT) over time-points (baseline - 4 weeks - 8 weeks)
The 6MWT is used, among other things, to assess and control cardiovascular and pulmonary performance below the anaerobic threshold. This test is used for the clinical evaluation of the basic motor property endurance and measures the distance a patient can walk as quickly as possible on a flat, hard surface in a period of 6 minutes. It will be measured in meters.
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)
The 30seconds Sit-to-Stand test is a well-established functional test used to estimate the strength endurance of the lower extremities and describes how often the test person can get up from a chair and sit down again in a period of 30 seconds. In patients suffering from chronic obstructive pulmonary disease (COPD), the 30seconds sit-to-stand test has proven to be a valid and reliable parameter.
Change of absolute body fat over time-points (baseline - 4 weeks - 8 weeks) via Bioelectrical Impedance Analysis (BiA)
BiA is a non-invasive method for measuring body composition and serves as a basis for assessing metabolic disease risks among others by measuring body fat in absolute (kg) numbers.
Change of body fat percentage over time-points (baseline - 4 weeks - 8 weeks) via Bioelectrical Impedance Analysis (BiA)
BiA is a non-invasive method for measuring body composition and serves as a basis for assessing metabolic disease risks among others by measuring body fat in relative (%) numbers.
Change of absolute Lean Body Mass (LBM) over time-points (baseline - 4 weeks - 8 weeks) via Bioelectrical Impedance Analysis (BiA)
BiA is a non-invasive method for measuring body composition and serves as a basis for assessing metabolic disease risks among others by measuring lean body mass in absolute (kg) numbers.
Change of realtive Lean Body Mass (LBM) over time-points (baseline - 4 weeks - 8 weeks) via Bioelectrical Impedance Analysis (BiA)
BiA is a non-invasive method for measuring body composition and serves as a basis for assessing metabolic disease risks among others by measuring lean body mass in relative (%) numbers.
Change of generalized anxiety measured over time-points (baseline - 4 weeks - 8 weeks) via Generalized Anxiety Disorder Scale-7 (GAD-7)
The GAD-7 (Generalized Anxiety Disorder 7) is a module of the health questionnaire for patients (PHQ-D), which was designed to identify patients with generalized anxiety disorder and to record the severity of symptoms of generalized anxiety (7 items). Scores range from 0 to 21 points with low scores representing low general anxiety and high scores representing high general anxiety.
Change of depression measured over time-points (baseline - 4 weeks - 8 weeks) via the Patient Health Questionnaire-9 (PHQ-9)
The questionnaire PHQ-9 corresponds to the depression module of the health questionnaire for patients (PHQ-D). It was developed as a screening instrument for the diagnosis of depression for routine use in the somatic medical field (9 items). Scores range from 0 to 27 points with low scores representing low levels of depression and high scores representing high levels of depression.
Change of mental stress measured over time-points (baseline - 4 weeks - 8 weeks) via Perceived Stress Scale (PSS-10)
The PSS-10 measures the subjective experience of stress. It records the dimensions of self-efficacy and helplessness in two scales, as well as an overall stress score (10 items). Scores range from 0 to 50 points with low scores representing low stress levels and high scores representing high stress levels.
Change of fatigue measured over time-points (baseline - 4 weeks - 8 weeks) via Brief Fatigue Inventory (BFI)
The BFI measures the severity and extent of fatigue. The questionnaire covers six dimensions: activity, mood, ability to walk, work, relationship with other people and joie de vivre (10 items). Scores range from 0 to 10 points with low scores representing low fatigue and high scores representing high fatigue.
Change of resilience measured over time-points (baseline - 4 weeks - 8 weeks) via Brief Resilience Scale (BRS)
The Brief Resilience Scale measures resilience, the ability to successfully cope with difficult, stressful situations or to recover quickly from them (6 items). Scores range from 1 to 5 points with low scores representing low resilience and high scores representing high resilience.
Change and time kinetics of handgrip strength (HGS) over time-points (baseline and before each exercise session) measured via handgrip Dynamometer.
Data on the fist force in kg (measurement of the basic motor property force), which are collected using a JAMAR® dynamometer.
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)
The Post-COVID-19 Functional Scale is a questionnaire for self-assessment of physical and functional limitations after a COVID-19 infection. It ranges from 0 (no functional impairment) to 4 (severe functional impairments).
Change of work ability over time-points (baseline, 4 weeks, 8 weeks) via Work Ability Index (WAI) questionnaire.
The Work Ability Index (WAI) is a measuring instrument for recording the work ability of employees. The WAI is a questionnaire that is filled out either by the respondents themselves or by third parties, e.g. company doctors during the company medical examination. The WAI is predictive of reintegration into working life after workplace-specific rehabilitation against back pain. WAI scores range from 7-27 (poor), over 28-36 (moderate), and 37 to 43 (good) to 44-49 (very good).
Change of troponin (TnT) over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
TnT (0 - 14 ng/L) is a heart-specific and very sensitive marker for myocardial damage in case of elevated values
Change of BNP over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
BNP (0 - 125 pg/ml) is increased in cardiac insufficiency and increased volume load on the heart
Change of CK-MB over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
CK-MB (< 24 U/l) are elevated in cardiac muscle diseases e.g. myocardial infarction, myocarditis, ischemic conditions e.g. angina pectoris, or for the differential diagnosis of muscle diseases
Change of HS-CRP over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
CRP (< 0,5 mg/dl) is an "acute phase protein" which increases in infections (bacterial, less viral and fungi), inflammation, post-OP, malignant processes; ultra-sensitive CRP is additionally a risk assessment marker of aterosclerosis
Change of IL-6 over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
IL-6 (<= 7 pg/mL) is a mediator of the immune system and elevated in inflammatory processes
Change of cholesterol over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
Cholesterol (< 200 mg/dL) is a risk factor for early atherosclerosis
Change of triglycerides over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
Triglycerides (< 150 mg/dl) increased in primary hyperlipidemia as a risk faktor for cardiovascular diseases
Change of distance walked in meters per day over time
Spare time physical activity is a key indicator for physical function and will be measured via activity tracker
Change of time of physical activity per day in minutes over time
Spare time physical activity is a key indicator for physical function and will be measured via activity tracker
Change of step count per day over time
Spare time physical activity is a key indicator for physical function and will be measured via activity tracker
Change of average heart rate per day over time
A low average heart rate during activities of daily living is an indicator for a relatively low cardiovascular load
Change of maximum heart rate per day over time
A low maximum heart rate during activities of daily living is an indicator for a relatively lower level of cardiovascular load
Change of average oxygen saturation (in %) per day over time
A high oxygen saturation is an indicator for a well functioning gas exchange in the lungs and distribution into the circulatory system
Change of Mild Cognitive Impairment over time-points (baseline, 8 weeks) via Montreal Cognitive Assessment (MoCA)
The MoCA test is a screening instrument for Mild Cognitive Impairment. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
Change of sleep quality over time points (baseline, 4 weeks, 8 weeks) via Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) is a brief self-report instrument measuring the patient's perception of both nocturnal and diurnal symptoms of insomnia.

Full Information

First Posted
April 7, 2021
Last Updated
December 23, 2021
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT04841759
Brief Title
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 3, 2021 (Actual)
Study Completion Date
December 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Long-COVID, SARS-CoV fatigue syndrome, Exercise, Rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Stratification regarding post-COVID-19 fatigue syndrome at baseline yes/no
Masking
Participant
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post COVID-19 fatigue at baseline "yes"
Arm Type
Experimental
Arm Description
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)
Arm Title
Post COVID-19 fatigue at baseline "no"
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
8 week exercise program, nutritional & psychological consultation
Primary Outcome Measure Information:
Title
Change of maximum oxygen uptake (VO2max) over time-points (baseline - 4 weeks - 8 weeks) assessed during cardio-pulmonary exercise testing (CPET)
Description
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.
Time Frame
Baseline, 4 weeks, 8 weeks
Secondary Outcome Measure Information:
Title
Change of walking distance during a six minutes walk test (6MWT) over time-points (baseline - 4 weeks - 8 weeks)
Description
The 6MWT is used, among other things, to assess and control cardiovascular and pulmonary performance below the anaerobic threshold. This test is used for the clinical evaluation of the basic motor property endurance and measures the distance a patient can walk as quickly as possible on a flat, hard surface in a period of 6 minutes. It will be measured in meters.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
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)
Description
The 30seconds Sit-to-Stand test is a well-established functional test used to estimate the strength endurance of the lower extremities and describes how often the test person can get up from a chair and sit down again in a period of 30 seconds. In patients suffering from chronic obstructive pulmonary disease (COPD), the 30seconds sit-to-stand test has proven to be a valid and reliable parameter.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change of absolute body fat over time-points (baseline - 4 weeks - 8 weeks) via Bioelectrical Impedance Analysis (BiA)
Description
BiA is a non-invasive method for measuring body composition and serves as a basis for assessing metabolic disease risks among others by measuring body fat in absolute (kg) numbers.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change of body fat percentage over time-points (baseline - 4 weeks - 8 weeks) via Bioelectrical Impedance Analysis (BiA)
Description
BiA is a non-invasive method for measuring body composition and serves as a basis for assessing metabolic disease risks among others by measuring body fat in relative (%) numbers.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change of absolute Lean Body Mass (LBM) over time-points (baseline - 4 weeks - 8 weeks) via Bioelectrical Impedance Analysis (BiA)
Description
BiA is a non-invasive method for measuring body composition and serves as a basis for assessing metabolic disease risks among others by measuring lean body mass in absolute (kg) numbers.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change of realtive Lean Body Mass (LBM) over time-points (baseline - 4 weeks - 8 weeks) via Bioelectrical Impedance Analysis (BiA)
Description
BiA is a non-invasive method for measuring body composition and serves as a basis for assessing metabolic disease risks among others by measuring lean body mass in relative (%) numbers.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change of generalized anxiety measured over time-points (baseline - 4 weeks - 8 weeks) via Generalized Anxiety Disorder Scale-7 (GAD-7)
Description
The GAD-7 (Generalized Anxiety Disorder 7) is a module of the health questionnaire for patients (PHQ-D), which was designed to identify patients with generalized anxiety disorder and to record the severity of symptoms of generalized anxiety (7 items). Scores range from 0 to 21 points with low scores representing low general anxiety and high scores representing high general anxiety.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change of depression measured over time-points (baseline - 4 weeks - 8 weeks) via the Patient Health Questionnaire-9 (PHQ-9)
Description
The questionnaire PHQ-9 corresponds to the depression module of the health questionnaire for patients (PHQ-D). It was developed as a screening instrument for the diagnosis of depression for routine use in the somatic medical field (9 items). Scores range from 0 to 27 points with low scores representing low levels of depression and high scores representing high levels of depression.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change of mental stress measured over time-points (baseline - 4 weeks - 8 weeks) via Perceived Stress Scale (PSS-10)
Description
The PSS-10 measures the subjective experience of stress. It records the dimensions of self-efficacy and helplessness in two scales, as well as an overall stress score (10 items). Scores range from 0 to 50 points with low scores representing low stress levels and high scores representing high stress levels.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change of fatigue measured over time-points (baseline - 4 weeks - 8 weeks) via Brief Fatigue Inventory (BFI)
Description
The BFI measures the severity and extent of fatigue. The questionnaire covers six dimensions: activity, mood, ability to walk, work, relationship with other people and joie de vivre (10 items). Scores range from 0 to 10 points with low scores representing low fatigue and high scores representing high fatigue.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change of resilience measured over time-points (baseline - 4 weeks - 8 weeks) via Brief Resilience Scale (BRS)
Description
The Brief Resilience Scale measures resilience, the ability to successfully cope with difficult, stressful situations or to recover quickly from them (6 items). Scores range from 1 to 5 points with low scores representing low resilience and high scores representing high resilience.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change and time kinetics of handgrip strength (HGS) over time-points (baseline and before each exercise session) measured via handgrip Dynamometer.
Description
Data on the fist force in kg (measurement of the basic motor property force), which are collected using a JAMAR® dynamometer.
Time Frame
Baseline, and before every supervised resistance exercise session
Title
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)
Description
The Post-COVID-19 Functional Scale is a questionnaire for self-assessment of physical and functional limitations after a COVID-19 infection. It ranges from 0 (no functional impairment) to 4 (severe functional impairments).
Time Frame
Baseline, and before every supervised resistance exercise session
Title
Change of work ability over time-points (baseline, 4 weeks, 8 weeks) via Work Ability Index (WAI) questionnaire.
Description
The Work Ability Index (WAI) is a measuring instrument for recording the work ability of employees. The WAI is a questionnaire that is filled out either by the respondents themselves or by third parties, e.g. company doctors during the company medical examination. The WAI is predictive of reintegration into working life after workplace-specific rehabilitation against back pain. WAI scores range from 7-27 (poor), over 28-36 (moderate), and 37 to 43 (good) to 44-49 (very good).
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change of troponin (TnT) over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
Description
TnT (0 - 14 ng/L) is a heart-specific and very sensitive marker for myocardial damage in case of elevated values
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change of BNP over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
Description
BNP (0 - 125 pg/ml) is increased in cardiac insufficiency and increased volume load on the heart
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change of CK-MB over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
Description
CK-MB (< 24 U/l) are elevated in cardiac muscle diseases e.g. myocardial infarction, myocarditis, ischemic conditions e.g. angina pectoris, or for the differential diagnosis of muscle diseases
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change of HS-CRP over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
Description
CRP (< 0,5 mg/dl) is an "acute phase protein" which increases in infections (bacterial, less viral and fungi), inflammation, post-OP, malignant processes; ultra-sensitive CRP is additionally a risk assessment marker of aterosclerosis
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change of IL-6 over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
Description
IL-6 (<= 7 pg/mL) is a mediator of the immune system and elevated in inflammatory processes
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change of cholesterol over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
Description
Cholesterol (< 200 mg/dL) is a risk factor for early atherosclerosis
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change of triglycerides over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
Description
Triglycerides (< 150 mg/dl) increased in primary hyperlipidemia as a risk faktor for cardiovascular diseases
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change of distance walked in meters per day over time
Description
Spare time physical activity is a key indicator for physical function and will be measured via activity tracker
Time Frame
From the first exercise session over 8 weeks until the last exercise session (daily)
Title
Change of time of physical activity per day in minutes over time
Description
Spare time physical activity is a key indicator for physical function and will be measured via activity tracker
Time Frame
From the first exercise session over 8 weeks until the last exercise session (daily)
Title
Change of step count per day over time
Description
Spare time physical activity is a key indicator for physical function and will be measured via activity tracker
Time Frame
From the first exercise session over 8 weeks until the last exercise session (daily)
Title
Change of average heart rate per day over time
Description
A low average heart rate during activities of daily living is an indicator for a relatively low cardiovascular load
Time Frame
From the first exercise session over 8 weeks until the last exercise session (daily)
Title
Change of maximum heart rate per day over time
Description
A low maximum heart rate during activities of daily living is an indicator for a relatively lower level of cardiovascular load
Time Frame
From the first exercise session over 8 weeks until the last exercise session (daily)
Title
Change of average oxygen saturation (in %) per day over time
Description
A high oxygen saturation is an indicator for a well functioning gas exchange in the lungs and distribution into the circulatory system
Time Frame
From the first exercise session over 8 weeks until the last exercise session (daily)
Title
Change of Mild Cognitive Impairment over time-points (baseline, 8 weeks) via Montreal Cognitive Assessment (MoCA)
Description
The MoCA test is a screening instrument for Mild Cognitive Impairment. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
Time Frame
Baseline, 8 weeks
Title
Change of sleep quality over time points (baseline, 4 weeks, 8 weeks) via Insomnia Severity Index (ISI)
Description
The Insomnia Severity Index (ISI) is a brief self-report instrument measuring the patient's perception of both nocturnal and diurnal symptoms of insomnia.
Time Frame
Baseline, 4 weeks, 8 weeks
Other Pre-specified Outcome Measures:
Title
Status of bone resorption at baseline
Description
Carboxy-terminal type I collagen (CTX-1; 0.003-0.44 ng/ml) is a marker of bone resorption.
Time Frame
Baseline only
Title
Status of bone formation at baseline
Description
Procollagen type 1 amino-terminal propeptide (P1NP; 20-92 ng/ml) is an early marker of bone formation.
Time Frame
Baseline only
Title
Status of bone turnover at baseline
Description
Bone-specific alkaline phosphatase (BAP) is used to detect minor changes in bone turnover.
Time Frame
Baseline only
Title
Status of bone mineralization at baseline
Description
Osteocalcin (Oc; 11-46 ng/ml) is a late marker of bone formation.
Time Frame
Baseline only
Title
Status of calcium metabolism at baseline
Description
25-OH-vitamin D (75-250 nmol/l) is the precursor for calcitriol, the active form of vitamin D which is essential for calcium metabolism
Time Frame
Baseline only
Title
Status of serum calcium concentration regulation at baseline
Description
Parathyroid hormone (PTH; 15-65 pg/ml) regulates the serum calcium concentration through its effects on bone, kidney, and intestine.
Time Frame
Baseline only

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32644129
Citation
Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
Results Reference
background
PubMed Identifier
32730238
Citation
Tenforde MW, Kim SS, Lindsell CJ, Billig Rose E, Shapiro NI, Files DC, Gibbs KW, Erickson HL, Steingrub JS, Smithline HA, Gong MN, Aboodi MS, Exline MC, Henning DJ, Wilson JG, Khan A, Qadir N, Brown SM, Peltan ID, Rice TW, Hager DN, Ginde AA, Stubblefield WB, Patel MM, Self WH, Feldstein LR; IVY Network Investigators; CDC COVID-19 Response Team; IVY Network Investigators. Symptom Duration and Risk Factors for Delayed Return to Usual Health Among Outpatients with COVID-19 in a Multistate Health Care Systems Network - United States, March-June 2020. MMWR Morb Mortal Wkly Rep. 2020 Jul 31;69(30):993-998. doi: 10.15585/mmwr.mm6930e1.
Results Reference
background
PubMed Identifier
32764112
Citation
Belli S, Balbi B, Prince I, Cattaneo D, Masocco F, Zaccaria S, Bertalli L, Cattini F, Lomazzo A, Dal Negro F, Giardini M, Franssen FME, Janssen DJA, Spruit MA. Low physical functioning and impaired performance of activities of daily life in COVID-19 patients who survived hospitalisation. Eur Respir J. 2020 Oct 15;56(4):2002096. doi: 10.1183/13993003.02096-2020. Print 2020 Oct.
Results Reference
background
PubMed Identifier
32729939
Citation
Halpin SJ, McIvor C, Whyatt G, Adams A, Harvey O, McLean L, Walshaw C, Kemp S, Corrado J, Singh R, Collins T, O'Connor RJ, Sivan M. Postdischarge symptoms and rehabilitation needs in survivors of COVID-19 infection: A cross-sectional evaluation. J Med Virol. 2021 Feb;93(2):1013-1022. doi: 10.1002/jmv.26368. Epub 2020 Aug 17.
Results Reference
background
PubMed Identifier
32199474
Citation
The Lancet. COVID-19: protecting health-care workers. Lancet. 2020 Mar 21;395(10228):922. doi: 10.1016/S0140-6736(20)30644-9. No abstract available.
Results Reference
background
PubMed Identifier
32441196
Citation
Barranco R, Ventura F. Covid-19 and infection in health-care workers: An emerging problem. Med Leg J. 2020 Jul;88(2):65-66. doi: 10.1177/0025817220923694. Epub 2020 May 22.
Results Reference
background
PubMed Identifier
32658823
Citation
Salazar de Pablo G, Vaquerizo-Serrano J, Catalan A, Arango C, Moreno C, Ferre F, Shin JI, Sullivan S, Brondino N, Solmi M, Fusar-Poli P. Impact of coronavirus syndromes on physical and mental health of health care workers: Systematic review and meta-analysis. J Affect Disord. 2020 Oct 1;275:48-57. doi: 10.1016/j.jad.2020.06.022. Epub 2020 Jun 25.
Results Reference
background
PubMed Identifier
28501804
Citation
Hilfiker R, Meichtry A, Eicher M, Nilsson Balfe L, Knols RH, Verra ML, Taeymans J. Exercise and other non-pharmaceutical interventions for cancer-related fatigue in patients during or after cancer treatment: a systematic review incorporating an indirect-comparisons meta-analysis. Br J Sports Med. 2018 May;52(10):651-658. doi: 10.1136/bjsports-2016-096422. Epub 2017 May 13.
Results Reference
background
PubMed Identifier
19726392
Citation
Wood LJ, Nail LM, Winters KA. Does muscle-derived interleukin-6 mediate some of the beneficial effects of exercise on cancer treatment-related fatigue? Oncol Nurs Forum. 2009 Sep;36(5):519-24. doi: 10.1188/09.ONF.519-524.
Results Reference
background
PubMed Identifier
28181204
Citation
Marzetti E, Calvani R, Tosato M, Cesari M, Di Bari M, Cherubini A, Broccatelli M, Savera G, D'Elia M, Pahor M, Bernabei R, Landi F; SPRINTT Consortium. Physical activity and exercise as countermeasures to physical frailty and sarcopenia. Aging Clin Exp Res. 2017 Feb;29(1):35-42. doi: 10.1007/s40520-016-0705-4. Epub 2017 Feb 8.
Results Reference
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PubMed Identifier
32398306
Citation
Klok FA, Boon GJAM, Barco S, Endres M, Geelhoed JJM, Knauss S, Rezek SA, Spruit MA, Vehreschild J, Siegerink B. The Post-COVID-19 Functional Status scale: a tool to measure functional status over time after COVID-19. Eur Respir J. 2020 Jul 2;56(1):2001494. doi: 10.1183/13993003.01494-2020. Print 2020 Jul.
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Links:
URL
https://covid19.who.int/
Description
WHO (2021) WHO Coronavirus Disease (COVID-19)

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The Effects of a Multi-factorial Rehabilitation Program for Healthcare Workers Suffering From Post-COVID-19 Fatigue Syndrome

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