Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome

Long COVID-19 Clinical Trial

— COVID-19  

Official title:

Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04961333
• Other study ID #: Danderyd University Hospital
• Status: Recruiting
• Phase: N/A
• Start date: April 23, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2021
• Source: Danderyd Hospital
• Contact: Indre Bileviciute-Ljungar, Associated professor
• Phone: +46858703158
• Email: indre.ljungar[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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.

Related Conditions & MeSH terms

• Long COVID-19

Intervention

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.

Locations

Country	Name	City	State
Sweden	St Göran Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Danderyd Hospital	St Göran Hospital, Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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