RCT Long COVID-19 Rehabilitation

Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06085911
• Other study ID #: 587293
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2023
• Est. completion date: November 2025

Study information

• Verified date: September 2023
• Source: University Hospital of North Norway
• Contact: Maja Wilhelmsen, MD, Ph.d
• Phone: +4777627834
• Email: maja.wilhelmsen[@]unn.no
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• Rehabilitation

Intervention

Behavioral:
• One day course
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-ups
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.

Locations

Country	Name	City	State
Norway	University hospital of North Norway	Tromsø	Troms

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital of North Norway	Norwegian University of Science and Technology, Oslo University Hospital, University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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.	12 month follow-up
Secondary	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.	3-12 months
Secondary	Work improvement	Improvement in work participation	3-12 months
Secondary	Quality of life improvement	Improvement in quality of life measured by EQ-5D-5L and measurement of Quality-adjusted life year (QALY)	3-12 months
Secondary	Neuropsychological functions improvement	Improvement of neuropsychological functions	6 months