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

A study testing Exercise in people with COVID-19, run by Medical University of Vienna at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Exercise
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteAustria
Study dates: 1 Apr 2021to 22 Dec 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Austria1 site

Medical University of Vienna
Vienna, 1090

Other trials in Austria

About this study

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.

Read the 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.

Conditions: COVID-19
Being tested: Exercise
Keywords: Long-COVID, SARS-CoV fatigue syndrome, Exercise, Rehabilitation
Medical subject headings: COVID-19, Post-Acute COVID-19 Syndrome, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ExerciseOther
8 week exercise program, nutritional \& psychological consultation

Study groups in NCT04841759
Study group	Role	What they receive
Post COVID-19 fatigue at baseline "yes"	Experimental	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) Receives: Other: Exercise
Post COVID-19 fatigue at baseline "no"	Active comparator	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) Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, 4 weeks, 8 weeks

Secondary outcomes (29)

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.
Measured: 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)
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.
Measured: Baseline, 4 weeks, 8 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Baseline, 4 weeks, 8 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks
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.
Measured: 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.
Data on the fist force in kg (measurement of the basic motor property force), which are collected using a JAMAR® dynamometer.
Measured: 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)
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).
Measured: Baseline, and before every supervised resistance exercise session
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).
Measured: Baseline, 4 weeks, 8 weeks
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
Measured: Baseline, 4 weeks, 8 weeks
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
Measured: Baseline, 4 weeks, 8 weeks
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
Measured: Baseline, 4 weeks, 8 weeks
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
Measured: Baseline, 4 weeks, 8 weeks
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
Measured: Baseline, 4 weeks, 8 weeks
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
Measured: Baseline, 4 weeks, 8 weeks
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
Measured: Baseline, 4 weeks, 8 weeks
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
Measured: 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
Spare time physical activity is a key indicator for physical function and will be measured via activity tracker
Measured: From the first exercise session over 8 weeks until the last exercise session (daily)
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
Measured: From the first exercise session over 8 weeks until the last exercise session (daily)
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
Measured: From the first exercise session over 8 weeks until the last exercise session (daily)
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
Measured: From the first exercise session over 8 weeks until the last exercise session (daily)
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
Measured: From the first exercise session over 8 weeks until the last exercise session (daily)
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.
Measured: Baseline, 8 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 202122 Dec 2021

First posted12 Apr 2021
Study start1 Apr 2021
Primary completion3 Dec 2021
Study completion22 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by Medical University of ViennaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Stratification regarding post-COVID-19 fatigue syndrome at baseline yes/no
Masking: Single blind
Who is masked: Participant
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04841759
Sponsor's protocol ID: 1181/2021
Status last verified: Dec 2021
First submitted: 7 Apr 2021
Last updated: 27 Dec 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 32644129
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.
PubMed 32730238
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.
PubMed 32764112
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.
PubMed 32729939
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.
PubMed 32199474
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.
PubMed 32441196
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.
PubMed 32658823
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.
PubMed 28501804
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.
PubMed 19726392
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.
PubMed 28181204
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.
PubMed 32398306
Hasenoehrl T, Palma S, Huber DF, Kastl S, Steiner M, Jordakieva G, Crevenna R. Post-COVID: effects of physical exercise on functional status and work ability in health care personnel. Disabil Rehabil. 2023 Sep;45(18):2872-2878. doi: 10.1080/09638288.2022.2111467. Epub 2022 Aug 18.
PubMed 35980383

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of a Multi-factorial Rehabilitation Program for Healthcare Workers Suffering From Post-COVID-19 Fatigue Syndrome
ClinicalTrials.gov ID: NCT04841759
Acronym / sponsor ID: 1181/2021
Conditions: COVID-19
Keywords: Long-COVID, SARS-CoV fatigue syndrome, Exercise, Rehabilitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Medical University of ViennaUniversity, hospital or other
Study start: 1 Apr 2021 (actual)
Primary completion: 3 Dec 2021 (actual)
Study completion: 22 Dec 2021 (actual)
First posted: 12 Apr 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Parallel to this workplace health promotion program, the scientific evaluation of this intevention will be undertaken via this study.

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Stratification regarding post-COVID-19 fatigue syndrome at baseline yes/no

Arm	Type	Receives
Post COVID-19 fatigue at baseline "yes"	Experimental	Other: ExerciseSARS-CoV2 survivor who attends the exercise program and suffers from post-COVID-19 fatigue Syndrome according to the Post-Covid-19-Functional Scale (PCFS)
Post COVID-19 fatigue at baseline "no"	Active comparator	Other: ExerciseSARS-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)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Exercise8 week exercise program, nutritional \& psychological consultation	Other	Post COVID-19 fatigue at baseline "no", Post COVID-19 fatigue at baseline "yes"

Primary outcome

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

29 secondary outcomes

Change of walking distance during a six minutes walk test (6MWT) over time-points (baseline - 4 weeks - 8 weeks)
Time frame: 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)
Time frame: Baseline, 4 weeks, 8 weeks
Change of absolute body fat over time-points (baseline - 4 weeks - 8 weeks) via Bioelectrical Impedance Analysis (BiA)
Time frame: Baseline, 4 weeks, 8 weeks
Change of body fat percentage over time-points (baseline - 4 weeks - 8 weeks) via Bioelectrical Impedance Analysis (BiA)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline, 4 weeks, 8 weeks
Change of mental stress measured over time-points (baseline - 4 weeks - 8 weeks) via Perceived Stress Scale (PSS-10)
Time frame: Baseline, 4 weeks, 8 weeks
Change of fatigue measured over time-points (baseline - 4 weeks - 8 weeks) via Brief Fatigue Inventory (BFI)
Time frame: Baseline, 4 weeks, 8 weeks
Change of resilience measured over time-points (baseline - 4 weeks - 8 weeks) via Brief Resilience Scale (BRS)
Time frame: 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.
Time frame: 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)
Time frame: Baseline, and before every supervised resistance exercise session
Change of work ability over time-points (baseline, 4 weeks, 8 weeks) via Work Ability Index (WAI) questionnaire.
Time frame: Baseline, 4 weeks, 8 weeks
Change of troponin (TnT) over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
Time frame: Baseline, 4 weeks, 8 weeks
Change of BNP over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
Time frame: Baseline, 4 weeks, 8 weeks
Change of CK-MB over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
Time frame: Baseline, 4 weeks, 8 weeks
Change of HS-CRP over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
Time frame: Baseline, 4 weeks, 8 weeks
Change of IL-6 over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
Time frame: Baseline, 4 weeks, 8 weeks
Change of cholesterol over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
Time frame: Baseline, 4 weeks, 8 weeks
Change of triglycerides over time-points (baseline - 4 weeks - 8 weeks) via blood sample.
Time frame: Baseline, 4 weeks, 8 weeks
Change of distance walked in meters per day over time
Time frame: 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
Time frame: From the first exercise session over 8 weeks until the last exercise session (daily)
Change of step count per day over time
Time frame: From the first exercise session over 8 weeks until the last exercise session (daily)
Change of average heart rate per day over time
Time frame: From the first exercise session over 8 weeks until the last exercise session (daily)
Change of maximum heart rate per day over time
Time frame: From the first exercise session over 8 weeks until the last exercise session (daily)
Change of average oxygen saturation (in %) per day over time
Time frame: From the first exercise session over 8 weeks until the last exercise session (daily)
Change of Mild Cognitive Impairment over time-points (baseline, 8 weeks) via Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, 8 weeks
Change of sleep quality over time points (baseline, 4 weeks, 8 weeks) via Insomnia Severity Index (ISI)
Time frame: Baseline, 4 weeks, 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
Background: PubMed 32644129Carfi 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.
Background: PubMed 32730238Tenforde 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.
Background: PubMed 32764112Belli 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.
Background: PubMed 32729939Halpin 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.
Background: PubMed 32199474The 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.
Background: PubMed 32441196Barranco 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.
Background: PubMed 32658823Salazar 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.
Background: PubMed 28501804Hilfiker 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.
Background: PubMed 19726392Wood 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.
Background: PubMed 28181204Marzetti 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.
Background: PubMed 32398306Klok 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.
Derived from this study: PubMed 35980383Hasenoehrl T, Palma S, Huber DF, Kastl S, Steiner M, Jordakieva G, Crevenna R. Post-COVID: effects of physical exercise on functional status and work ability in health care personnel. Disabil Rehabil. 2023 Sep;45(18):2872-2878. doi: 10.1080/09638288.2022.2111467. Epub 2022 Aug 18.
WHO (2021) WHO Coronavirus Disease (COVID-19)Link provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for COVID-19

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with COVID-19, run by Medical University of Vienna at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of maximum oxygen uptake (VO2max) over time-points (baseline - 4 weeks - 8 weeks) assessed during cardio-pulmonary exercise testing (CPET) (time frame: Baseline, 4 weeks, 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04841759, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2021.