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COVID Rehabilitation

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
One day course
Individual follow-ups
Sponsored by
University Hospital of North Norway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rehabilitation focused on measuring Rehabilitation, Long COVID, Clinical trial, Telemedicine, Inflammation, Post-Acute COVID-19 Syndrome, COVID-19, Post-Infectious Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    individual follow-ups

    a one-day course.

    Arm Description

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

    a one-day course.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    Work improvement
    Improvement in work participation
    Quality of life improvement
    Improvement in quality of life measured by EQ-5D-5L and measurement of Quality-adjusted life year (QALY)
    Neuropsychological functions improvement
    Improvement of neuropsychological functions

    Full Information

    First Posted
    October 16, 2023
    Last Updated
    October 16, 2023
    Sponsor
    University Hospital of North Norway
    Collaborators
    University of Bergen, Oslo University Hospital, Norwegian University of Science and Technology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06085911
    Brief Title
    COVID Rehabilitation
    Official Title
    Intervention Against Long COVID in Norway - Systematic Rehabilitation. A Randomised Pilot and Feasibility Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    February 2025 (Anticipated)
    Study Completion Date
    November 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital of North Norway
    Collaborators
    University of Bergen, Oslo University Hospital, Norwegian University of Science and Technology

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized controlled trial (RCT) comparing two intervention groups
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    individual follow-ups
    Arm Type
    Experimental
    Arm Description
    tailored individual follow-up rehabilitation program with home-based exercises
    Arm Title
    a one-day course.
    Arm Type
    Active Comparator
    Arm Description
    a one-day course.
    Intervention Type
    Behavioral
    Intervention Name(s)
    One day course
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Individual follow-ups
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Symptom reduction
    Description
    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.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Symptoms grouped by systems reduction
    Description
    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.
    Time Frame
    12 month follow-up
    Title
    Graded symptom reduction
    Description
    Graded responses for separate symptoms and symptom constellations, including an ordinal variable graded 0-3 for the presence of neurocognitive relevant symptoms and dyspnea.
    Time Frame
    3-12 months
    Title
    Work improvement
    Description
    Improvement in work participation
    Time Frame
    3-12 months
    Title
    Quality of life improvement
    Description
    Improvement in quality of life measured by EQ-5D-5L and measurement of Quality-adjusted life year (QALY)
    Time Frame
    3-12 months
    Title
    Neuropsychological functions improvement
    Description
    Improvement of neuropsychological functions
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maja Wilhelmsen, MD, Ph.d
    Phone
    +4777627834
    Email
    maja.wilhelmsen@unn.no
    First Name & Middle Initial & Last Name or Official Title & Degree
    Synne Garner Pedersen, ph.d
    Phone
    +4791838630
    Email
    Synne.Garder.Pedersen@unn.no
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maja Wilhelmsen, ph.d
    Organizational Affiliation
    University Hospital of North Norway
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    COVID Rehabilitation

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