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

NCT ID: NCT04841759

Last Updated: 2021-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2021-12-22

Brief Summary

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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

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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

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COVID-19

Keywords

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Long-COVID SARS-CoV fatigue syndrome Exercise Rehabilitation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Stratification regarding post-COVID-19 fatigue syndrome at baseline yes/no
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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)

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

8 week exercise program, nutritional \& psychological consultation

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)

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

8 week exercise program, nutritional \& psychological consultation

Interventions

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Exercise

8 week exercise program, nutritional \& psychological consultation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Richard Crevenna

Univ.-Prof. Dr. MBA MMSc, Head of Department of Physical Medicine, Rehabilitation and Occupational Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

References

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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.

Reference Type BACKGROUND
PMID: 32644129 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32730238 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32764112 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32729939 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32199474 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32441196 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32658823 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28501804 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19726392 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28181204 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32398306 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35980383 (View on PubMed)

Related Links

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https://covid19.who.int/

WHO (2021) WHO Coronavirus Disease (COVID-19)

Other Identifiers

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1181/2021

Identifier Type: -

Identifier Source: org_study_id