Long COVID-19COVID-19NCT04961333
Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome
A study testing Multidisciplinary Rehabilitation in people with Long COVID-19, run by Danderyd Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Long COVID-19
- What is being tested?
- Multidisciplinary Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 23 Apr 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
St Göran Hospital
Stockholm, 112 19
Indre Bileviciute-Ljungar, Associated professor, +46858703158, indre.ljungar@ki.se
Kristian Borg, professor, +46812355000, kristian.borg@ki.se
About this study
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.
- Conditions
- Long COVID-19
- Being tested
- Multidisciplinary Rehabilitation
- Keywords
- COVID-19, rehabilitation, telemedicine, multidisciplinary
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary RehabilitationBehavioural
Also called Individually performed physical activity recorded into ExorLie app.
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.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation group | Experimental | 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. Receives: Behavioral: Multidisciplinary Rehabilitation |
| Waiting list controls | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Investigators expect normalisation at 6 months follow-up
Secondary outcomes (2)
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.
Measured: 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)
Measured: Investigators expect normalisation at 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start23 Apr 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Intervention group and waiting list control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St Göran Hospital, Stockholm
- Responsible party
- Principal investigator, Indre Ljungar, Danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961333
- Sponsor's protocol ID
- Danderyd University Hospital
- Acronym
- COVID-19
- Status last verified
- Jul 2021
- First submitted
- 7 May 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome
- ClinicalTrials.gov ID
- NCT04961333
- Acronym / sponsor ID
- COVID-19 / Danderyd University Hospital
- Conditions
- Long COVID-19
- Keywords
- COVID-19, rehabilitation, telemedicine, multidisciplinary
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Collaborators
- St Göran Hospital, Stockholm
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Intervention group and waiting list control group
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation group | Experimental | Behavioral: Multidisciplinary RehabilitationRehabilitation 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. |
| Waiting list controls | No intervention | –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. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary RehabilitationAlso: Individually performed physical activity recorded into ExorLie app.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. | Behavioural | Rehabilitation group |
Primary outcome
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)
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
2 secondary outcomes
Overall changed scores in validated questionnaires for fatigue, breathing, pain and sleep disorders
Time frame: Investigators expect changes already at 6 months follow-up
Changed functioning and activity
Time frame: Investigators expect normalisation at 6 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary Rehabilitation in people with Long COVID-19, run by Danderyd Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Indre Bileviciute-Ljungar, Associated professor (+46858703158, indre.ljungar@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in health-related quality of life measured by Short Form-36 (time frame: Investigators expect changes at 6 months follow-up after rehabilitation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.