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Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome (COVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04961333
Recruitment Status : Recruiting
First Posted : July 14, 2021
Last Update Posted : July 14, 2021
Sponsor:
Collaborator:
St Göran Hospital, Stockholm
Information provided by (Responsible Party):
Indre Ljungar, Danderyd Hospital

Brief Summary:
Internet-based multidisciplinary interventions will be offered to participants suffering from longterm COVID-19 syndrome. Data will be collected by internet platform at Karolinska Institutet (BASS) before, after rehabilitation and at follow-up after 6 months. Both self-scored questionnaires and physical tests performed at home will be collected to understand the symptomatology, functioning and activity level. Rehabilitation during 8 weeks period will be given in groups as face-to-group, pre-recorded film sessions and by individual approach, the participants will use ExorLive app for physical activity.

Condition or disease Intervention/treatment Phase
Long COVID-19 Behavioral: Multidisciplinary Rehabilitation Not Applicable

Detailed Description:

This randomised study aimed to understand if multidisciplinary internet-based interventions performed in group and individually are applicable for participants suffering from longterm COVID-19 syndrome. Data will be collected by internet platform at Karolinska Institutet (BASS) before, after rehabilitation and at follow-up after 6 months. Both self-scored questionnaires and physical tests performed at home will be collected to understand the symptomatology, functioning and activity level. Rehabilitation during 8 weeks period will be given in groups as face-to-group, pre-recorded film sessions and by individual approach, the participants will use ExorLive app for physical activity.

The participants will be randomised for treatment and waiting lists using a website random.org. Waiting list will be offered rehabilitation interventions after at least 8 weeks period of waiting to exclude a spontaneous improvement or worsening of symptoms. To understand the impact of rehabilitation on work capacity and employment/economic supply, the data from Social Insurance databas will be obtained 2021 year before and upp to 2 years after the intervention. To understand the impact of rehabilitation on sickness-leave, the data from National Insurance Agency will be obtained for 2021 and 2022.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Intervention group and waiting list control group
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome
Actual Study Start Date : April 23, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Rehabilitation group
Rehabilitation group will be provided multidisciplinary interventions online and individually by ExorLive app. The screening with self-scored questionnaires and physical tests will be performed before and after 8 weeks rehabilitation.
Behavioral: Multidisciplinary Rehabilitation
Body therapies to improve breathing, normalise dysfunction in the autonomic nervous system, relaxation, mindfulness, in some part Acceptance and Commitment Therapy given preferably through body therapies.
Other Name: Individually performed physical activity recorded into ExorLie app.

No Intervention: Waiting list controls
Passive waiting list or control group, which will be offered to participate in rehabilitation after at least 8 weeks of waiting time. The group will fulfil screening twice, following the time schedule of intervention group. When invited to rehabilitation a new screening will be asked to be completed if the waiting time after the last screening will be longer than 2 weeks.



Primary Outcome Measures :
  1. Change in health-related quality of life measured by Short Form-36 [ Time Frame: Investigators expect changes at 6 months follow-up after rehabilitation ]
    Important sub scales: vitality, general health, physical functioning, pain. Scale varies between 0 and 100 (highest)

  2. Changes in heart rate variability during physical tests [ Time Frame: Investigators expect normalisation at 6 months follow-up ]
    Heart rate variability measured by puls oximeter during 2 physical tests


Secondary Outcome Measures :
  1. Overall changed scores in validated questionnaires for fatigue, breathing, pain and sleep disorders [ Time Frame: Investigators expect changes already at 6 months follow-up ]
    Validated self-scored questionnaires such as Multidimentional Fatigue Inventory - for fatigue (values 0-20), Clinical COPD Questionnaire - for breathing (0-50), Chronic Visual Analogue Scale - for pain (0-100), Insomnia Severity Scale - for sleep (0-21) and other questionnaires.

  2. Changed functioning and activity [ Time Frame: Investigators expect normalisation at 6 months follow-up ]
    Functioning and activity will be evaluated by self-scored questionnaires and a new questionnaire Functional compass for COVID-19 based on ICF (International Classification of Functioning and Disability)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • confirmed COVID-19 infection
  • post-infection symptoms lasting longer than 3-6 months
  • clinically stable persons regarding symtoms or other co-morbidities
  • ability to participate in internet-based rehabilitation in group in Swedish.

Exclusion Criteria:

  • uncertainty regarding covid-19 infection or co-morbidities started or exacerbated during the same time
  • alcohol and drug abuse
  • untreated psychiatric and somatic co-morbidities
  • undergoing medical or psychotherapeutic treatment or rehabilitation which can interact with rehabilitation outcomes.

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): NCT04961333


Contacts
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Contact: Indre Bileviciute-Ljungar, Associated professor +46858703158 indre.ljungar@ki.se
Contact: Kristian Borg, professor +46812355000 kristian.borg@ki.se

Locations
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Sweden
St Göran Hospital Recruiting
Stockholm, Sweden, 112 19
Contact: Indre Bileviciute-Ljungar, Associated professor    +46858703158    indre.ljungar@ki.se   
Contact: Kristian Borg, professor    +46812355000    kristian.borg@ki.se   
Sponsors and Collaborators
Danderyd Hospital
St Göran Hospital, Stockholm
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Responsible Party: Indre Ljungar, associated professor in rehabilitation medicine, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT04961333    
Other Study ID Numbers: Danderyd University Hospital
First Posted: July 14, 2021    Key Record Dates
Last Update Posted: July 14, 2021
Last Verified: July 2021

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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 Indre Ljungar, Danderyd Hospital:
COVID-19
rehabilitation
telemedicine
multidisciplinary