Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome
- Conditions
- Long COVID-19
- Interventions
- Behavioral: Multidisciplinary Rehabilitation
- Registration Number
- NCT04961333
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Rehabilitation group Multidisciplinary Rehabilitation 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.
- Primary Outcome Measures
Name Time Method Changes in heart rate variability during physical tests Investigators expect normalisation at 6 months follow-up Heart rate variability measured by puls oximeter during 2 physical tests
Change in health-related quality of life measured by Short Form-36 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)
- Secondary Outcome Measures
Name Time Method Overall changed scores in validated questionnaires for fatigue, breathing, pain and sleep disorders 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.
Changed functioning and activity 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)
Trial Locations
- Locations (1)
St Göran Hospital
🇸🇪Stockholm, Sweden