Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome

NCT ID: NCT04961333

Last Updated: 2021-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-23

Study Completion Date

2022-12-31

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.

Conditions

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Long COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Intervention group and waiting list control group
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Multidisciplinary Rehabilitation

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Individually performed physical activity recorded into ExorLie app.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St Göran Hospital, Stockholm

UNKNOWN

Sponsor Role collaborator

Danderyd Hospital

OTHER

Sponsor Role lead

Responsible Party

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Indre Ljungar

associated professor in rehabilitation medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St Göran Hospital

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Indre Bileviciute-Ljungar, Associated professor

Role: CONTACT

+46858703158

Kristian Borg, professor

Role: CONTACT

+46812355000

Facility Contacts

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Indre Bileviciute-Ljungar, Associated professor

Role: primary

+46858703158

Kristian Borg, professor

Role: backup

+46812355000

Other Identifiers

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Danderyd University Hospital

Identifier Type: -

Identifier Source: org_study_id

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