RCT Long COVID-19 Rehabilitation

NCT06085911 | Unknown

• 1 other identifier: 587293
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Rehabilitation; Long COVID; Clinical trial; Telemedicine; Inflammation; Post-Acute COVID-19 Syndrome; COVID-19; Post-Infectious Disorders

Outcome Measures

Primary Outcomes (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.

  3 months

Secondary Outcomes (5)

• Symptoms grouped by systems reduction

  12 month follow-up

• Graded symptom reduction

  3-12 months

• Work improvement

  3-12 months

• Quality of life improvement

  3-12 months

• Neuropsychological functions improvement

  6 months

Study Arms (2)

individual follow-ups

EXPERIMENTAL

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

Behavioral: Individual follow-ups

a one-day course.

ACTIVE COMPARATOR

a one-day course.

Behavioral: One day course

Interventions

One day course BEHAVIORAL

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.

a one-day course.

Individual follow-ups BEHAVIORAL

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.

individual follow-ups

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of North Norway: lead
• University of Bergen: collaborator
• Oslo University Hospital: collaborator
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

University hospital of North Norway

Tromsø, Troms, 9038, Norway

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Post-Infectious Disorders; Inflammation; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maja Wilhelmsen, ph.d

  University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maja Wilhelmsen, MD, Ph.d

CONTACT

+4777627834; maja.wilhelmsen@unn.no

Synne G Pedersen, ph.d

CONTACT

+4791838630; Synne.Garder.Pedersen@unn.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled trial (RCT) comparing two intervention groups

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 17, 2023
• Study Start: November 3, 2023
• Primary Completion: February 1, 2025
• Study Completion: November 1, 2025
• Last Updated: June 11, 2024

Record last verified: 2023-09

Locations

NO (1)