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Clinical Trials/NCT04961333
NCT04961333
Unknown
N/A

Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome

Danderyd Hospital1 site in 1 country200 target enrollmentApril 23, 2021
ConditionsLong COVID-19

Overview

Phase
N/A
Intervention
Not specified
Conditions
Long COVID-19
Sponsor
Danderyd Hospital
Enrollment
200
Locations
1
Primary Endpoint
Changes in heart rate variability during physical tests
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 23, 2021
End Date
December 31, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Danderyd Hospital
Responsible Party
Principal Investigator
Principal Investigator

Indre Ljungar

associated professor in rehabilitation medicine

Danderyd Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Changes in heart rate variability during physical tests

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

Heart rate variability measured by puls oximeter during 2 physical tests

Change in health-related quality of life measured by Short Form-36

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

Important sub scales: vitality, general health, physical functioning, pain. Scale varies between 0 and 100 (highest)

Secondary Outcomes

  • Overall changed scores in validated questionnaires for fatigue, breathing, pain and sleep disorders(Investigators expect changes already at 6 months follow-up)
  • Changed functioning and activity(Investigators expect normalisation at 6 months follow-up)

Study Sites (1)

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