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

NCT04841759 | Completed

• 1 other identifier: 1181/2021
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Long-COVID; SARS-CoV fatigue syndrome; Exercise; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Baseline, 4 weeks, 8 weeks

• Change of numbers over time-points (baseline - 4 weeks - 8 weeks) how often someone can stand up and sit down on a chair within 30 seconds during a 30-seconds sit-to-stand test (30secSTS)

  Baseline, 4 weeks, 8 weeks

• Change of absolute body fat over time-points (baseline - 4 weeks - 8 weeks) via Bioelectrical Impedance Analysis (BiA)

  Baseline, 4 weeks, 8 weeks

• Change of body fat percentage over time-points (baseline - 4 weeks - 8 weeks) via Bioelectrical Impedance Analysis (BiA)

  Baseline, 4 weeks, 8 weeks

• Change of absolute Lean Body Mass (LBM) over time-points (baseline - 4 weeks - 8 weeks) via Bioelectrical Impedance Analysis (BiA)

  Baseline, 4 weeks, 8 weeks

Other Outcomes (6)

• Status of bone resorption at baseline

  Baseline only

• Status of bone formation at baseline

  Baseline only

• Status of bone turnover at baseline

  Baseline only

Study Arms (2)

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)

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)

Other: Exercise

Interventions

Exercise OTHER

8 week exercise program, nutritional \& psychological consultation

Post COVID-19 fatigue at baseline "no"; Post COVID-19 fatigue at baseline "yes"

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (12)

• 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.

  PMID: 32644129 BACKGROUND

• 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.

  PMID: 32730238 BACKGROUND

• 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.

  PMID: 32764112 BACKGROUND

• 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.

  PMID: 32729939 BACKGROUND

• 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.

  PMID: 32199474 BACKGROUND

• 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.

  PMID: 32441196 BACKGROUND

• 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.

  PMID: 32658823 BACKGROUND

• 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.

  PMID: 28501804 BACKGROUND

• 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.

  PMID: 19726392 BACKGROUND

• 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.

  PMID: 28181204 BACKGROUND

• 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.

  PMID: 32398306 BACKGROUND

• 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.

  PMID: 35980383 DERIVED

Related Links

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

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr. MBA MMSc, Head of Department of Physical Medicine, Rehabilitation and Occupational Medicine

Model Details: Stratification regarding post-COVID-19 fatigue syndrome at baseline yes/no

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 12, 2021
• Study Start: April 1, 2021
• Primary Completion: December 3, 2021
• Study Completion: December 22, 2021
• Last Updated: December 27, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)