Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome (COVID-19)

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.

Study Overview

• Status: Recruiting
• Conditions: Long COVID-19
• Intervention / Treatment: Behavioral: Multidisciplinary Rehabilitation

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: Interventional
• Enrollment (Anticipated): 200
• 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

• Sweden
  • Stockholm, Sweden, 112 19
    • Recruiting
    • St Goran Hospital
    • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

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.	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.; Other Names: Individually performed physical activity recorded into ExorLie app.
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.

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	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

Collaborators and Investigators

• Sponsor: Danderyd Hospital
• Collaborators: St Göran Hospital, Stockholm

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: May 7, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: rehabilitation; COVID-19; telemedicine; multidisciplinary
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Danderyd University Hospital

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No