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

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ClinicalTrials.gov Identifier: NCT04375709
Recruitment Status : Recruiting
First Posted : May 5, 2020
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Kantonsspital Winterthur KSW

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.


Condition or disease Intervention/treatment
Covid-19 (New Coronavirus) Infection Other: Physical exercise Behavioral: Education sessions

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Health-related Quality of Life (HRQOL) and Physical Performance in Individuals After COVID-19 Induced Hospitalisation and the Impact of a Standard Care Follow-up Program: a Longitudinal Observational Cohort Study
Actual Study Start Date : March 15, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Physical exercise
    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.
  • Behavioral: Education sessions
    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.


Primary Outcome Measures :
  1. Health-related quality of life; EuroQoL (EQ-5D-5L) [ Time Frame: 01.04.2020 - 30.05.2021 ]

    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.


  2. 6-minute walk test [ Time Frame: 01.04.2020 - 30.05.2021 ]
    6-minute walk test measures the distance acquired during six minutes walking, it quantifies the physical performance, dyspnoea and endurance.


Secondary Outcome Measures :
  1. Jamar dynamometer [ Time Frame: 01.04.2020 - 30.05.2021 ]
    Measures the handgrip strength and is associated with sarcopenia, mortality and independence in life (e.g. for older individuals and patients after or with critical illness)

  2. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 01.04.2020 - 30.05.2021 ]
    Self-administered questionnaire on anxiety and depression after hospitalization; bot, anxiety and depression is quantified by an ordinal scale from 0-3, respectively. The lower the number the less signs of depression or anxiety are present.

  3. revised Impact of Event Scale (IES-R) [ Time Frame: 01.04.2020 - 30.05.2020 ]
    Questionnaire on avoidance, intrusion and arousal (or overreaction) in order to identify potential risk for post-traumatic stress. The Scale includes 22 questions ordinally scored from "not at all" to " very frequent" with four scores. The scores are transformed into numbers (0,1,3,5). The values are put in a formula resulting in a single value.A value below zero indicates no risk of post-traumatic stress disorder (PTSD) is present. Values equal or higher than zero indicate the risk of a PTSD

  4. Mini-Nutritional Assessment (MNA) [ Time Frame: 01.04.2020 - 30.05.2021 ]
    Questionnaire on the nutritional condition of the patient. It includes 16 questions and 2 measures. Points range from 0-30; A score <17 indicates malnutirtion, a score from 17-23.5 indicates a risk of malnutrition and scores between 24-30 indicate normal nutritional behaviour.

  5. Spirometry (bed-side) [ Time Frame: 01.04.2020 - 30.05.2021 ]
    Measures the lung function (bedside screening)

  6. Post-Covid Functional Scale (PCFS) [ Time Frame: 01.04.2020 - 30.05.2021 ]
    This scale measures the functional state and Independence of patients after COVID-19 infection. The scale includes two items scored from 0-4 and 0-5. A high value indicates more restrictions in function and independence during daily life.

  7. modified Medical Research Council Dyspnoea Scale (mMRC Dyspnoea) [ Time Frame: 01.04.2020 - 30.05.2021 ]
    Quantifies and stratifies the perception of dyspnoea with a score ranging from 0-4. The higher the value the more frequent and more severe is the perception of dyspnoea during daily life activities.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult individuals after COVID-19 infection hospitalized at the Kantonsspital Winterthur (Switzerland)
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Specific exclusion criteria for presence at the hospital (for evaluation and training); criteria will be verified during the phone-based screening process. After two weeks of a COVID-19 positive diagnosis and with four entire days the patient reports no signs of:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04375709


Contacts
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Contact: Martina Betschart, PhD +41 52 266 48 90 ext 37 48 martina1.betschart@ksw.ch
Contact: David Gisi +41 52 266 48 90 david.gisi@ksw.ch

Locations
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Switzerland
Kantonsspital Winterthur Recruiting
Winterthur, Zürich, Switzerland, 8401
Contact: Martina Betschart, PhD    +41 52 266 48 90 ext 37 48    martina1.betschart@ksw.ch   
Contact: David Gisi    +41 52 266 48 90    david.gisi@ksw.ch   
Sponsors and Collaborators
Kantonsspital Winterthur KSW
Investigators
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Study Director: David Gisi Kantonsspital Winterthur KSW
Principal Investigator: Martina Betschart, PhD Kantonsspital Winterthur KSW
Study Chair: 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 Director: Cornel Sieber, Prof. MD Kantonsspital Winterthur KSW
Additional Information:
Publications:
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 Mölken 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. Erratum in: Am J Respir Crit Care Med. 2014 Jun 15;189(12):1570.

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Responsible Party: Kantonsspital Winterthur KSW
ClinicalTrials.gov Identifier: NCT04375709    
Other Study ID Numbers: 2020_00899 / COV19_2020
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kantonsspital Winterthur KSW:
COVID-19
SARS-V2
Quality of Life
Physical Performance
Additional relevant MeSH terms:
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Infections
COVID-19
Coronavirus Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases