CClinicalTrials.gg
Status unknownNCT04961333COVID-19Updated Jul 14, 2021

Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome

An interventional study of Multidisciplinary Rehabilitation in Long COVID-19, sponsored by Danderyd Hospital. Status unknown at 1 site in Sweden. Open to participants aged 18 Years to 67 Years. Per ClinicalTrials.gov, last updated 2021-07-14.

Sponsored by Danderyd Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 67 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Long COVID-19

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Keywords

  • COVID-19
  • rehabilitation
  • telemedicine
  • multidisciplinary
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Danderyd Hospital is the lead sponsor of 58 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 67 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
200 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralMultidisciplinary 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.

    Also known as: Individually performed physical activity recorded into ExorLie app.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Investigators expect changes at 6 months follow-up after rehabilitation

  2. Changes in heart rate variability during physical tests

    Heart rate variability measured by puls oximeter during 2 physical tests

    Time frame: Investigators expect normalisation at 6 months follow-up

Secondary outcomes

  1. 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.

    Time frame: Investigators expect changes already at 6 months follow-up

  2. 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)

    Time frame: Investigators expect normalisation at 6 months follow-up

07

Study locations

1 of 1 sites recruiting
  • St Göran Hospital
    Stockholm, 112 19, Sweden
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04961333
Lead sponsor
Danderyd Hospital
Collaborators
St Göran Hospital, Stockholm
Responsible party
Indre Ljungar (associated professor in rehabilitation medicine, Danderyd Hospital) — Principal investigator
First posted
Jul 14, 2021
Start date
Apr 23, 2021
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Jul 14, 2021

Study contacts

Indre Bileviciute-Ljungar, Associated professor
Contact
indre.ljungar@ki.se
+46858703158
Kristian Borg, professor
Contact
kristian.borg@ki.se
+46812355000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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