Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome (COVID-19)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Indre Bileviciute-Ljungar, Associated professor
- Phone Number: +46858703158
- Email: indre.ljungar@ki.se
Study Contact Backup
- Name: Kristian Borg, professor
- Phone Number: +46812355000
- Email: kristian.borg@ki.se
Study Locations
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Stockholm, Sweden, 112 19
- Recruiting
- St Goran Hospital
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Contact:
- Indre Bileviciute-Ljungar, Associated professor
- Phone Number: +46858703158
- Email: indre.ljungar@ki.se
-
Contact:
- Kristian Borg, professor
- Phone Number: +46812355000
- Email: kristian.borg@ki.se
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
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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 Names:
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in health-related quality of life measured by Short Form-36
Time Frame: Investigators expect changes at 6 months follow-up after rehabilitation
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Important sub scales: vitality, general health, physical functioning, pain.
Scale varies between 0 and 100 (highest)
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Investigators expect changes at 6 months follow-up after rehabilitation
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Changes in heart rate variability during physical tests
Time Frame: Investigators expect normalisation at 6 months follow-up
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Heart rate variability measured by puls oximeter during 2 physical tests
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Investigators expect normalisation at 6 months follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall changed scores in validated questionnaires for fatigue, breathing, pain and sleep disorders
Time Frame: Investigators expect changes already at 6 months follow-up
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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.
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Investigators expect changes already at 6 months follow-up
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Changed functioning and activity
Time Frame: Investigators expect normalisation at 6 months follow-up
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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)
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Investigators expect normalisation at 6 months follow-up
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Danderyd University Hospital
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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