Department of Rehabilitaiton Medicine Stockholm
Stockholm, 18288, Sweden
NCT Number: NCT07821385
Since 2020, millions of individuals have been infected with SARS-CoV-2 virus and a substantial proportion continue to experience persistent symptoms that impair functional capacity, limit daily activities, and negatively affect quality of life. The terminology and definitions surrounding this condition remain diverse, such as long COVID, post-COVID-19 syndrome or ongoing symptomatic COVID-19 . In October 2021, the World Health Organization (WHO) introduced the term post-COVID condition (PCC) through a Delphi consensus process defined as:
"As the persistence or onset of new symptoms three months after the initial SARS-CoV-2 infection, with symptoms lasting for at least two months and not explained by alternative diagnoses".
PCC is characterized by a wide range of symptoms, most commonly fatigue, cognitive impairments, muscle weakness, respiratory and cardiac symptoms, and pain often occurring alongside anxiety, depression, and sleep disturbances. Research shows that PCC markedly impairs activities of daily living (ADL), work ability, and overall functioning. Qualitative studies further demonstrate that the combination of physical and cognitive symptoms limits individuals' ability to engage in everyday occupations and reduce work capacity. Consequently, PCC is associated with difficulties in maintaining employment, often resulting in prolonged sick leave, reduced working hours, or the need for workplace accommodations. Given the heterogeneous nature of PCC, its impact on everyday life varies between individuals, highlighting the importance of understanding patients´ own experiences and priorities when planning rehabilitation interventions.
Global efforts have focused on understanding and managing PCC, with rehabilitation emerging as a central strategy. Rehabilitation strategies seem to be a key intervention for improving fatigue, cognitive dysfunction, mood disturbances, and decrease overall well-being; however, current evidence is heterogeneous and insufficient to establish standardized interventions. A lack of research on PCC patients would lead to profound consequences for both patients and society. Without such knowledge, patients' risk of being misdiagnosed or receiving inadequate care, rehabilitation efforts may be ineffective, and healthcare systems will struggle to allocate resources properly. This increases long-term disability, reduces work ability, and places an avoidable burden on individuals and society. Therefore, a deeper understanding of the scope and nature of PCC is essential for understanding this patient group better, developing effective rehabilitation approaches and informing public health policy.
The goal of this observational study is to learn more about the impact of post-COVID condition (PCC) on individuals' everyday occupational performance, cognitive functioning, perceived health, and life satisfaction, with the aim of understanding these patient groups better, and to generate evidence to guide rehabilitation strategies. The research focuses on patients diagnosed with post-COVID condition who are receiving an interprofessional rehabilitation program at a specialized Rehabilitation Clinic in Sweden, Danderyds Hospital,
The main questions aim to answer are:
* Which activities do individuals with PCC identify as most important to improve, and how do they rate these activities in terms of performance and satisfaction? * How do individuals with PCC rate their overall health and occupational performance before and after participating in an interprofessional rehabilitation program?
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Notify Me18 year–65 year
All sexes
Observational
Stockholm, 18288, Sweden
This is a prospective clinical cohort study, describing occupational performance, cognitive dysfunction and health aspects within patients with post-COVID condition (PCC), which have participated in an interprofessional rehabilitation program. Data collection began in 2021 and continued through 2025. Participants were recruited prior to initiation of rehabilitation and assessed at baseline, immediately post-intervention, and at six-month follow-up.
Setting The study was conducted at the Stockholm Department of Rehabilitation Medicine, Danderyd University Hospital, within the Cognitive Post-COVID Clinic .
Participants Between August 2021 and December 2025, patients with persistent cognitive symptoms and fatigue following mild COVID-19 infection were assessed for eligibility. A total of approximately 100 patients aged 18-65 years were included.
All patients underwent a comprehensive interdisciplinary assessment to determine the need for and potential benefit from interprofessional multimodal rehabilitation (IMR). Only patients who provided written informed consent were enrolled in the study.
Intervention:
Interprofessional Rehabilitation Program The interprofessional rehabilitation program was initiated in spring 2021 and progressively refined based on expanding clinical knowledge of PCC and neurorehabilitation. The program is grounded in principles of chronic pain rehabilitation and neurorehabilitation.
Rehabilitation was delivered in a group-based, in-person format consisting of half-day sessions once weekly for 10 weeks. Participants attended together with other patients with PCC.
Interventions were individually adapted according to participants' energy levels and physical capacity and included:
Procedures Baseline Assessment
Prior to the start of rehabilitation:
Assessments were conducted:
Study Objectives
The planned analyses aim to:
Statistical Analysis and Sample Size The COPM is the primary outcome measure. The study has 90% power to detect a pre-post difference of 2.2 COPM points, assuming a standard deviation of 2.1, a significance level of 5%, and using non-parametric methods, with a sample size of 10 participants.
Non-parametric statistical methods will be applied due to the nature of the data. Spearman's rank correlation will be used for correlation analyses. Logistic regression analyses will be conducted to investigate factors associated with rehabilitation outcomes, including age, sex, and educational level.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
--A clear temporal link between COVID-19 onset and symptom onset, with symptoms affecting return to previous activities/occupation.
Exclusion criteria
The Interprofessional rehabilitation program (IPR) was delivered in a group format, one half day per week over 10 weeks. The interprofessional team comprised an occupational therapist, psychologist, physiotherapist, physician, and social worker. All patients underwent an initial team assessment to determine eligibility for the IRP. Based on this assessment; an individualized rehabilitation plan was developed prior to program initiation. The IPR included lectures, group discussions, and physical activity, with the overall goal of improving daily functioning and facilitating return to work when applicable.
Time frame: Before, after and at six months follow-up
The COPM assesses an individual's perceived occupational performance in the areas of self-care, productivity and leisure.
Semi-structured interview format and structured scoring method. The person rates/ describes which activities are important for them and after that satisfaction. The person rates importance, performance and satisfaction
Time frame: Before, after and at six month follow-up
The EuroQol 5D (EQ 5D) is a widely used measure of quality of life, the instrument consists of a health index with five dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Responses across these dimensions generate a health profile that can be converted into an EQ 5D index score, ranging from 0 (equivalent to death) to 1 (representing perfect health). In addition, the EQ 5D includes a Visual Analog Scale (VAS), on which respondents rate their perceived health status from 0 (worst imaginable health) to 100 (best imaginable health)
Time frame: Before, after and six month follow-up
The Hospital Anxiety and Depression Scale (HADS) was developed as a tool for identifying symptoms of anxiety and depression in patients attending hospital medical outpatient clinics, and it has been shown to be reliable for this purpose. Both the anxiety and depression subscales are considered valid indicators of the severity of these emotional disorders.
Time frame: Before, after and a six months follow-up
The RAND-36 item health survey is a 36-item questionnaire used as a generic measure of health-related quality of life (HRQoL). It assesses eight health domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to emotional problems, mental health, social functioning, vitality (energy/fatigue), and general health perceptions. Subscale scores range from 0 to 100, with higher scores indicating better health status. The RAND-36 has been translated into Swedish and psychometrically validated for use in the Swedish population.
Time frame: Before, after and at six months follow-up
The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report questionnaire developed to assess fatigue across five dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation, and Reduced Activity (5).
Time frame: Before, after and at six month follow-up
The Insomnia Severity Index (ISI) is a self-report questionnaire that assesses perceived insomnia severity. It evaluates subjective symptoms and consequences of insomnia, as well as the level of concern or distress associated with sleep difficulties. The instrument comprises seven items measuring the severity of sleep-onset and sleep-maintenance problems. Each item is rated on a 5-point scale (0-4), yielding a total score ranging from 0 to 28, with higher scores indicating more severe insomnia
Time frame: Before, after and at six month follow-up
The World Health Organization Disability Assessment Schedule (WHODAS) is a standardized instrument developed to evaluate disability and activity limitations associated with a wide range of health conditions, including acute and chronic diseases, injuries, mental and emotional disorders, and problems related to alcohol or substance use. WHODAS 12 is the abbreviated version of the 36 item WHODAS 2.0 and is a self administered questionnaire consisting of 12 items. It provides a global assessment of the impact of health conditions on daily functioning over the preceding 30 days
Danderyd Hospital
Other
Interprofessional Rehabilitation for Patients With Cognitive Dysfunction and Fatigue After COVID-19 Infection.
Acronym: Post-COVID
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