Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome

Conditions
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Long COVID-19

Intervention / Treatment
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* Behavioral: Multidisciplinary Rehabilitation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Intervention group and waiting list control group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rehabilitation group<br>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<br>* 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.<br>* Other names: Individually performed physical activity recorded into ExorLie app.;|
| No Intervention: Waiting list controls<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health-related quality of life measured by Short Form-36 | Important sub scales: vitality, general health, physical functioning, pain. Scale varies between 0 and 100 (highest) | Investigators expect changes at 6 months follow-up after rehabilitation | 
| Changes in heart rate variability during physical tests | Heart rate variability measured by puls oximeter during 2 physical tests | Investigators expect normalisation at 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall changed scores in validated questionnaires for fatigue, breathing, pain and sleep disorders | 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. | Investigators expect changes already at 6 months follow-up | 
| Changed functioning and activity | 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) | Investigators expect normalisation at 6 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, rehabilitation, telemedicine, multidisciplinary