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RehabilitationNCT06085911

RCT Long COVID-19 Rehabilitation

A study testing One day course and Individual follow-ups in people with Rehabilitation and Post-Acute COVID-19 Syndrome, run by University Hospital of North Norway at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The Coronavirus 2019 (COVID-19) pandemic has resulted in at least four million infections in Norway. The vast majority of cases are diagnosed and followed up in the community, but some with extensive symptoms and large degree of reduced function are referred to regional Covid-clinics. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
One day course and Individual follow-ups
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteNorway
Study dates
3 Nov 2023to Nov 2025
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptoms attributable to long COVID according to WHO definition [14] that affect their daily activities
  • Positive Covid test; a home-test, PCR test or serology.
  • Neurocognitive symptoms
  • Age between 18 and 65 years
  • Participant is able and willing to provide informed consent

Who cannot join

  • Patients that do not want to comply to planned physical study visits
  • Patients who are unable to complete surveys in Norwegian
  • Patients with known chronic neurocognitive disease before Covid-19 or other diseases that can explain current symptoms

Trial locations and contacts

1 site in 1 country.

Maja Wilhelmsen, MD, Ph.d contact

+4777627834

maja.wilhelmsen@unn.no

Synne G Pedersen, ph.d contact

+4791838630

Synne.Garder.Pedersen@unn.no

Norway1 site, 1 recruiting

  • University hospital of North Norway

    Tromsø, Troms, 9038

    Marte Wilhelsmen, MSc, +4777669163, marte.wilson@unn.no

    Maja Wilhelmsen, MD ph.d, +4977627834, maja.wilhelmsen@unn.no

    Recruiting

Other trials in Norway

About this study

Official title: Intervention Against Long COVID in Norway - Systematic Rehabilitation. A Randomised Pilot and Feasibility Study.

The Coronavirus 2019 (COVID-19) pandemic has resulted in at least four million infections in Norway. The vast majority of cases are diagnosed and followed up in the community, but some with extensive symptoms and large degree of reduced function are referred to regional Covid-clinics. In total this patient group is placing an enormous burden on the already over stretched health care services. As the pandemic subsides the emerging threat of long-term disability from COVID remains to be quantified. Brain fog and cognitive symptoms are common in long COVID in 30% of mild infections resulting in sick leave and loss of daily function, with women overrepresented among long COVID sufferers. The true prevalence and underlying mechanisms of long COVID remains to be quantified. Although vaccination prevents severe infection and death, we have little knowledge on how best to rehabilitate those who suffers from long COVID.

Here we propose to develop knowledge on treatment interventions to counteract disability from long COVID and lessening the burden on health care services. We will conduct a study of where we compare a short group intervention with systematic personalised neurocognitive rehabilitation to document symptom alleviation. Our overarching goal is to develop effective programmes for this evolving disease to reduce the suffering for the patients, and thereby reducing costs for health services and society at large.

Being tested
One day course, Individual follow-ups
Keywords
Rehabilitation, Long COVID, Clinical trial, Telemedicine, Inflammation, Post-Acute COVID-19 Syndrome, COVID-19, Post-Infectious Disorders
Medical subject headings
Post-Acute COVID-19 Syndrome, Post-Infectious Disorders, Inflammation, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • One day courseBehavioural

    a physical one-day course at the Covid rehabilitation clinic. During these six hours, general information about rehabilitation principals will be given. Theory about three 15 focus areas of importance will be presented; daily routine, importance of being active and cognitive training. They will meet others with similar problems and will be given an opportunity to exchange experience. 8-10 patients will participate in the group.

  • Individual follow-upsBehavioural

    the patient will meet a therapist in a physical consultation at the Covid rehabilitation clinic lasting for 1.5 hours. Together they will in detail map out symptoms and impairment of function in the patient's life. Together the patient and the therapist will create plan to address these problems consisting of tailored home-based exercises within the three focus areas. Tree follow-up consultations will be given.

Study groups in NCT06085911
Study groupRoleWhat they receive
individual follow-upsExperimentaltailored individual follow-up rehabilitation program with home-based exercises
Receives: Behavioral: Individual follow-ups
a one-day course.Active comparatora one-day course.
Receives: Behavioral: One day course

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptom reduction

    A reduction in number present symptoms is evaluated in each patient group. A significant greater alleviation in the of number symptoms at three months is considered as a better prognosis.

    Measured: 3 months

Secondary outcomes (5)

  1. Symptoms grouped by systems reduction

    All individual symptoms separately, and grouped by systems (systemic symptoms, chest-symptoms, cognitive, other neurocognitive symptoms) and as full recovery (absence of all symptoms) at 3-, 6- and 12 months.

    Measured: 12 month follow-up

  2. Graded symptom reduction

    Graded responses for separate symptoms and symptom constellations, including an ordinal variable graded 0-3 for the presence of neurocognitive relevant symptoms and dyspnea.

    Measured: 3-12 months

  3. Work improvement

    Improvement in work participation

    Measured: 3-12 months

  4. Quality of life improvement

    Improvement in quality of life measured by EQ-5D-5L and measurement of Quality-adjusted life year (QALY)

    Measured: 3-12 months

  5. Neuropsychological functions improvement

    Improvement of neuropsychological functions

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2023
  2. Study start3 Nov 2023
  3. Primary completionFeb 2025 (estimated)
  4. Study completionNov 2025 (estimated)

Resources

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
Parallel groups
Model description
randomized controlled trial (RCT) comparing two intervention groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06085911
Sponsor's protocol ID
587293
Status last verified
Sep 2023
First submitted
16 Oct 2023
Last updated
11 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wilson M, Michalsen H, Anke A, Pedersen SG, Espinasse M, Langeland N, Cox RJ, Aukrust P, Dahl TB, Sandvig A, Wilhelmsen M. Effectiveness of tailored individual follow-up vs. standard one-day group course on health-related quality of life in patients with post COVID-19 condition: a randomized controlled trial. Front Rehabil Sci. 2026 Sep 22;7:1927300. doi: 10.3389/fresc.2026.1927300. eCollection 2026.

    PubMed 42840070

  • Wilson M, Pedersen SG, Langeland N, Cox RJ, Aukrust P, Dahl TB, Sandvig A, Wilhelmsen M. Tailored Individual Follow-Ups Versus a One-Day Group Course in Patients With Long COVID (Post- COVID-19 Condition): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Jan 5;15:e74113. doi: 10.2196/74113.

    PubMed 41490577

Questions about this trial

What is this clinical trial studying?

A study testing One day course and Individual follow-ups in people with Rehabilitation and Post-Acute COVID-19 Syndrome, run by University Hospital of North Norway at 1 site in Norway.

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 5 inclusion and 3 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 11 Jun 2024. 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 Norway. 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 Maja Wilhelmsen, MD, Ph.d (+4777627834, maja.wilhelmsen@unn.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom reduction (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06085911, which also lists 2 linked publications.

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 11 Jun 2024.

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