Quality of Life and Physical Performance After Novel Coronavirus Infection (COVID-19);

NCT04375709 | Unknown

• 1 other identifier: 2020_00899 / COV19_2020
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to observe the long-term health-related quality of life (HRQOL) and physical performance in individuals hospitalized due to a COVID-19 infection. Therefore, data is extracted from a study-site standard aftercare program which has been adjusted for this patient population. This comprehensive aftercare program includes education sessions and physical exercise. A second aim is to observe adherence and feasibility to the program and if indicated compare the clinical data and outcomes from patients following the program with patients denying to participate in guided exercise and education sessions. It is expected that patients hospitalized due to COVID-19 infection show a reduction in physical performance and HRQOL directly after discharge. The severity of illness is hypothesized to be associated with a reduction as well in HRQOL and physical performance after one-year post-discharge.

Conditions

Covid-19 (New Coronavirus) Infection

Keywords

COVID-19; SARS-V2; Quality of Life; Physical Performance

Outcome Measures

Primary Outcomes (2)

• Health-related quality of life; EuroQoL (EQ-5D-5L)

  Self-managed questionnaire on functional status, anxiety, pain and independence in daily living; The EuroQoL includes a five item scale and a visual analog scale from 0-100 in order to quantify perception of current health. The five item scale includes ordinary scores from 0-5. Lower numbers equal less problems and better quality of life. For the visual analog scale a higher number represents a better health status perceived.

  01.04.2020 - 30.05.2021

• 6-minute walk test

  6-minute walk test measures the distance acquired during six minutes walking, it quantifies the physical performance, dyspnoea and endurance.

  01.04.2020 - 30.05.2021

Secondary Outcomes (7)

• Jamar dynamometer

  01.04.2020 - 30.05.2021

• Hospital Anxiety and Depression Scale (HADS)

  01.04.2020 - 30.05.2021

• revised Impact of Event Scale (IES-R)

  01.04.2020 - 30.05.2020

• Mini-Nutritional Assessment (MNA)

  01.04.2020 - 30.05.2021

• Spirometry (bed-side)

  01.04.2020 - 30.05.2021

Interventions

Physical exercise OTHER

The intervention consists out of combined aerobic and strength exercise supervised and guided by specialized physical therapists; additional methods like functional electrical stimulation or oxygen supplementation are added during the main training if indicated.

Education sessions BEHAVIORAL

Sessions include information on physical activity (behaviour), coping with stress and anxiety, dyspnoe, or fatigue; Professional support is given in case of risk for nutritional deficits or post-traumatic stress; sessions are conducted by medical specialists or specialized physiotherapists. All sessions are individually-tailored. In case of nutrition or psychological issues individual sessions are guided by specific health-professionals.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult individuals after COVID-19 infection hospitalized at the Kantonsspital Winterthur (Switzerland)

You may qualify if:

• Hospitalized at the Kantonsspital Winterthur (KSW) due to COVID-19 infection (laboratory-confirmed),
• with or without mechanically assisted ventilation
• being at risk to obtain severe illness caused by the COVID-19\*
• individuals without defined risk factors but requiring oxygenation during hospitalisation
• Agree to general consent or specific consent to subsequent use of his/her personal health data for research purpose
• German-speaking

You may not qualify if:

• Presence of mental disability or impairments to reasoning or judgment
• Individuals who are immunocompromised due to medical treatment
• A documented objection of subsequent use of personal health data
• fever \>37.3° C
• sore throat,
• cough (productive or non-productive)
• common cold
• Also, treatment-based immunocompromised patients are excluded for on-site evaluation and training.

Sponsors & Collaborators

• Kantonsspital Winterthur KSW: lead

Study Sites (1)

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8401, Switzerland

RECRUITING

Related Publications (23)

• Arabi YM, Murthy S, Webb S. Correction to: COVID-19: a novel coronavirus and a novel challenge for critical care. Intensive Care Med. 2020 May;46(5):1087-1088. doi: 10.1007/s00134-020-06009-2.

  PMID: 32189010 BACKGROUND

• Bohannon RW. Muscle strength: clinical and prognostic value of hand-grip dynamometry. Curr Opin Clin Nutr Metab Care. 2015 Sep;18(5):465-70. doi: 10.1097/MCO.0000000000000202.

  PMID: 26147527 BACKGROUND

• Dres M, Jung B, Molinari N, Manna F, Dube BP, Chanques G, Similowski T, Jaber S, Demoule A. Respective contribution of intensive care unit-acquired limb muscle and severe diaphragm weakness on weaning outcome and mortality: a post hoc analysis of two cohorts. Crit Care. 2019 Nov 21;23(1):370. doi: 10.1186/s13054-019-2650-z.

  PMID: 31752937 BACKGROUND

• Gandotra S, Lovato J, Case D, Bakhru RN, Gibbs K, Berry M, Files DC, Morris PE. Physical Function Trajectories in Survivors of Acute Respiratory Failure. Ann Am Thorac Soc. 2019 Apr;16(4):471-477. doi: 10.1513/AnnalsATS.201806-375OC.

  PMID: 30571923 BACKGROUND

• Hatch R, Young D, Barber V, Griffiths J, Harrison DA, Watkinson P. Anxiety, Depression and Post Traumatic Stress Disorder after critical illness: a UK-wide prospective cohort study. Crit Care. 2018 Nov 23;22(1):310. doi: 10.1186/s13054-018-2223-6.

  PMID: 30466485 BACKGROUND

• Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.

  PMID: 21470008 BACKGROUND

• Hosey MM, Bienvenu OJ, Dinglas VD, Turnbull AE, Parker AM, Hopkins RO, Neufeld KJ, Needham DM. The IES-R remains a core outcome measure for PTSD in critical illness survivorship research. Crit Care. 2019 Nov 19;23(1):362. doi: 10.1186/s13054-019-2630-3. No abstract available.

  PMID: 31744551 BACKGROUND

• Hsieh MJ, Lee WC, Cho HY, Wu MF, Hu HC, Kao KC, Chen NH, Tsai YH, Huang CC. Recovery of pulmonary functions, exercise capacity, and quality of life after pulmonary rehabilitation in survivors of ARDS due to severe influenza A (H1N1) pneumonitis. Influenza Other Respir Viruses. 2018 Sep;12(5):643-648. doi: 10.1111/irv.12566. Epub 2018 Jun 12.

  PMID: 29676537 BACKGROUND

• Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

  PMID: 31986264 BACKGROUND

• King J, O'Neill B, Ramsay P, Linden MA, Darweish Medniuk A, Outtrim J, Blackwood B. Identifying patients' support needs following critical illness: a scoping review of the qualitative literature. Crit Care. 2019 May 24;23(1):187. doi: 10.1186/s13054-019-2441-6.

  PMID: 31126335 BACKGROUND

• Lai CC, Liu YH, Wang CY, Wang YH, Hsueh SC, Yen MY, Ko WC, Hsueh PR. Asymptomatic carrier state, acute respiratory disease, and pneumonia due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): Facts and myths. J Microbiol Immunol Infect. 2020 Jun;53(3):404-412. doi: 10.1016/j.jmii.2020.02.012. Epub 2020 Mar 4.

  PMID: 32173241 BACKGROUND

• Ling Y, Xu SB, Lin YX, Tian D, Zhu ZQ, Dai FH, Wu F, Song ZG, Huang W, Chen J, Hu BJ, Wang S, Mao EQ, Zhu L, Zhang WH, Lu HZ. Persistence and clearance of viral RNA in 2019 novel coronavirus disease rehabilitation patients. Chin Med J (Engl). 2020 May 5;133(9):1039-1043. doi: 10.1097/CM9.0000000000000774.

  PMID: 32118639 BACKGROUND

• Major ME, Kwakman R, Kho ME, Connolly B, McWilliams D, Denehy L, Hanekom S, Patman S, Gosselink R, Jones C, Nollet F, Needham DM, Engelbert RH, van der Schaaf M. Surviving critical illness: what is next? An expert consensus statement on physical rehabilitation after hospital discharge. Crit Care. 2016 Oct 29;20(1):354. doi: 10.1186/s13054-016-1508-x.

  PMID: 27793165 BACKGROUND

• Sillen MJ, Franssen FM, Delbressine JM, Vaes AW, Wouters EF, Spruit MA. Efficacy of lower-limb muscle training modalities in severely dyspnoeic individuals with COPD and quadriceps muscle weakness: results from the DICES trial. Thorax. 2014 Jun;69(6):525-31. doi: 10.1136/thoraxjnl-2013-204388. Epub 2014 Jan 7.

  PMID: 24399630 BACKGROUND

• Singh SJ, Puhan MA, Andrianopoulos V, Hernandes NA, Mitchell KE, Hill CJ, Lee AL, Camillo CA, Troosters T, Spruit MA, Carlin BW, Wanger J, Pepin V, Saey D, Pitta F, Kaminsky DA, McCormack MC, MacIntyre N, Culver BH, Sciurba FC, Revill SM, Delafosse V, Holland AE. An official systematic review of the European Respiratory Society/American Thoracic Society: measurement properties of field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1447-78. doi: 10.1183/09031936.00150414. Epub 2014 Oct 30.

  PMID: 25359356 BACKGROUND

• Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.

  PMID: 24127811 BACKGROUND

• Taito S, Yamauchi K, Tsujimoto Y, Banno M, Tsujimoto H, Kataoka Y. Does enhanced physical rehabilitation following intensive care unit discharge improve outcomes in patients who received mechanical ventilation? A systematic review and meta-analysis. BMJ Open. 2019 Jun 9;9(6):e026075. doi: 10.1136/bmjopen-2018-026075.

  PMID: 31182443 BACKGROUND

• Tipping CJ, Young PJ, Romero L, Saxena MK, Dulhunty J, Hodgson CL. A systematic review of measurements of physical function in critically ill adults. Crit Care Resusc. 2012 Dec;14(4):302-11.

  PMID: 23230880 BACKGROUND

• Wolfel R, Corman VM, Guggemos W, Seilmaier M, Zange S, Muller MA, Niemeyer D, Jones TC, Vollmar P, Rothe C, Hoelscher M, Bleicker T, Brunink S, Schneider J, Ehmann R, Zwirglmaier K, Drosten C, Wendtner C. Virological assessment of hospitalized patients with COVID-2019. Nature. 2020 May;581(7809):465-469. doi: 10.1038/s41586-020-2196-x. Epub 2020 Apr 1.

  PMID: 32235945 BACKGROUND

• Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.

  PMID: 32105632 BACKGROUND

• Zanini A, Aiello M, Adamo D, Casale S, Cherubino F, Della Patrona S, Raimondi E, Zampogna E, Chetta A, Spanevello A. Estimation of minimal clinically important difference in EQ-5D visual analog scale score after pulmonary rehabilitation in subjects with COPD. Respir Care. 2015 Jan;60(1):88-95. doi: 10.4187/respcare.03272. Epub 2014 Oct 21.

  PMID: 25336531 BACKGROUND

• Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

  PMID: 32171076 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

Related Links

• Verified the 27th of April
• verified the 2nd of April 2020
• verified the 2nd of April 2020
• verified the 9nd of April 2020
• Guidelines on management of critical illness; verified the 9th of April 2020

MeSH Terms

Conditions

COVID-19; Infections

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• David Gisi

  Kantonsspital Winterthur KSW

  STUDY DIRECTOR

• Martina Betschart, PhD

  Kantonsspital Winterthur KSW

  PRINCIPAL INVESTIGATOR

• Spencer Rezek, MSc Cand.

  Kantonsspital Winterthur KSW

  STUDY CHAIR

• Ines Unger, MSc Cand.

  Kantonsspital Winterthur KSW

  STUDY CHAIR

• Natalie Ott, MSc Cand.

  Kantonsspital Winterthur KSW

  STUDY CHAIR

• Swantje Beyer, MD

  Kantonsspital Winterthur KSW

  STUDY CHAIR

• Markus Hofer, MD

  Kantonsspital Winterthur KSW

  STUDY CHAIR

• Karrer Urs, PD MD

  Kantonsspital Winterthur KSW

  STUDY CHAIR

• Giuseppe Mungo, MSc

  Kantonsspital Winterthur KSW

  STUDY CHAIR

• Cornel Sieber, Prof. MD

  Kantonsspital Winterthur KSW

  STUDY DIRECTOR

Central Study Contacts

Martina Betschart, PhD

CONTACT

+41 52 266 48 90; martina1.betschart@ksw.ch

David Gisi

CONTACT

+41 52 266 48 90; david.gisi@ksw.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 5, 2020
• Study Start: March 15, 2020
• Primary Completion: June 30, 2021
• Study Completion: August 31, 2021
• Last Updated: May 12, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)