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Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome

Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04961333
Acronym
COVID-19
Enrollment
200
Registered
2021-07-14
Start date
2021-04-23
Completion date
2022-12-31
Last updated
2021-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long COVID-19

Keywords

COVID-19, rehabilitation, telemedicine, multidisciplinary

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.

Interventions

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.

Sponsors

St Göran Hospital, Stockholm
CollaboratorUNKNOWN
Danderyd Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

Intervention group and waiting list control group

Eligibility

Sex/Gender
ALL
Age
18 Years to 67 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in health-related quality of life measured by Short Form-36Investigators expect changes at 6 months follow-up after rehabilitationImportant sub scales: vitality, general health, physical functioning, pain. Scale varies between 0 and 100 (highest)
Changes in heart rate variability during physical testsInvestigators expect normalisation at 6 months follow-upHeart rate variability measured by puls oximeter during 2 physical tests

Secondary

MeasureTime frameDescription
Overall changed scores in validated questionnaires for fatigue, breathing, pain and sleep disordersInvestigators expect changes already at 6 months follow-upValidated 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 activityInvestigators expect normalisation at 6 months follow-upFunctioning 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)

Countries

Sweden

Contacts

Primary ContactIndre Bileviciute-Ljungar, Associated professor
indre.ljungar@ki.se+46858703158
Backup ContactKristian Borg, professor
kristian.borg@ki.se+46812355000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026