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

Primary Purpose

Long COVID-19

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Multidisciplinary Rehabilitation
Sponsored by
Danderyd Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Long COVID-19 focused on measuring COVID-19, rehabilitation, telemedicine, multidisciplinary

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St Göran HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rehabilitation group

Waiting list controls

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
Changes in heart rate variability during physical tests
Heart rate variability measured by puls oximeter during 2 physical tests

Secondary Outcome Measures

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.
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)

Full Information

First Posted
May 7, 2021
Last Updated
July 12, 2021
Sponsor
Danderyd Hospital
Collaborators
St Göran Hospital, Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT04961333
Brief Title
Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome
Acronym
COVID-19
Official Title
Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 23, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danderyd Hospital
Collaborators
St Göran Hospital, Stockholm

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long COVID-19
Keywords
COVID-19, rehabilitation, telemedicine, multidisciplinary

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Intervention group and waiting list control group
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rehabilitation group
Arm Type
Experimental
Arm Description
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.
Arm Title
Waiting list controls
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multidisciplinary Rehabilitation
Other Intervention Name(s)
Individually performed physical activity recorded into ExorLie app.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in health-related quality of life measured by Short Form-36
Description
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
Title
Changes in heart rate variability during physical tests
Description
Heart rate variability measured by puls oximeter during 2 physical tests
Time Frame
Investigators expect normalisation at 6 months follow-up
Secondary Outcome Measure Information:
Title
Overall changed scores in validated questionnaires for fatigue, breathing, pain and sleep disorders
Description
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
Title
Changed functioning and activity
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Indre Bileviciute-Ljungar, Associated professor
Phone
+46858703158
Email
indre.ljungar@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Kristian Borg, professor
Phone
+46812355000
Email
kristian.borg@ki.se
Facility Information:
Facility Name
St Göran Hospital
City
Stockholm
ZIP/Postal Code
112 19
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Indre Bileviciute-Ljungar, Associated professor
Phone
+46858703158
Email
indre.ljungar@ki.se
First Name & Middle Initial & Last Name & Degree
Kristian Borg, professor
Phone
+46812355000
Email
kristian.borg@ki.se

12. IPD Sharing Statement

Learn more about this trial

Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome

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