RCT Long COVID-19 Rehabilitation

University Hospital of North Norway

Status: Enrolling

Conditions: Rehabilitation; Post-Acute COVID-19 Syndrome; Post-Infectious Disorders

Treatments: Behavioral: One day course; Behavioral: Individual follow-ups

Study type: Interventional

Funder types: Other

Identifiers

NCT06085911

587293

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

individual follow-ups

Experimental group

Description:

tailored individual follow-up rehabilitation program with home-based exercises

Treatment:

Behavioral: Individual follow-ups

a one-day course.

Active Comparator group

Description:

a one-day course.

Treatment:

Behavioral: One day course