AzTrials
AzTrials

PostCovidPost-COVIDNCT07821385

Interprofessional Rehabilitation for Patients With Post-COVID Condition

An observational study of PostCovid, run by Danderyd Hospital at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
PostCovid
What is being tested?
Interprofessional cognitive group rehabilitation
How many people
120 participants
Where
1 siteSweden
Study dates
20 Aug 2021to 15 Jan 2026
How long will I take part?
3 Months
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients aged 18-65 with persistent cognitive symptoms and fatigue following confirmed or strongly suspected COVID-19 infection, who have undergone assessment at the Cognitive Post-COVID Clinic at Danderyd Hospital and subsequently completed a team evaluation prior to participation in interdisciplinary rehabilitation. During the assessment, it is determined whether the patient needs and can benefit from rehabilitation.

Who may be able to join

  • Individuals aged 18 and older with confirmed COVID-19 or with a very likely prior COVID-19 infection.
  • Newly developed cognitive impairments or cognitive fatigue.
  • --A clear temporal link between COVID-19 onset and symptom onset, with symptoms affecting return to previous activities/occupation.
  • The acute phase of illness ended at least 3 months earlier.
  • Basic investigations for specific differential diagnoses must have been completed at the initial clinic visit, according to "COVID-19 - persistent symptoms" (see viss.nu), excluding anemia, thyroid dysfunction, and alcohol overconsumption. Assessment for depression.
  • Medication review and relevant adjustments carried out with regard to the patient's symptoms

Who cannot join

  • Predominant recurrent and/or fluctuating infectious symptoms, circulatory, respiratory, or cardiac problems.
  • Other symptoms due to organ failure that should primarily be managed by an organ specialist.
  • Severe psychiatric illness, including depression with pronounced cognitive symptoms.
  • Cognitive impairments primarily related to neurodegenerative disease or substance misuse, e.g., alcohol-related dementia, Korsakoff's dementia, or other dementia disorders.

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Department of Rehabilitaiton Medicine Stockholm

    Stockholm, 18288

Other trials in Sweden

About this study

Official title: Interprofessional Rehabilitation for Patients With Cognitive Dysfunction and Fatigue After COVID-19 Infection.

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".

Read more

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?
Read the detailed description

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:

  • Educational components (theory and lectures)
  • Physical activity
  • Body awareness training
  • Pacing strategies
  • Cognitive and behavioral strategies aimed at improving daily functioning and facilitating return to work when applicable The interdisciplinary rehabilitation team comprised an occupational therapist, psychologist, physiotherapist, physician, and social worker.

Procedures Baseline Assessment

Prior to the start of rehabilitation:

  • All participants completed self-reported questionnaires addressing health, quality of life, and psychological well-being
  • Occupational performance and satisfaction were assessed using the Canadian Occupational Performance Measure (COPM) during occupational therapy evaluation
  • Background variables including age, sex, educational level, and family situation were recorded Follow-Up Assessments

Assessments were conducted:

  1. Immediately after completion of the rehabilitation program
  2. Six months post-rehabilitation At follow-up, participants completed the same outcome measures as at baseline, with additional assessments of fatigue, insomnia, and participation.

Study Objectives

The planned analyses aim to:

  1. Evaluate changes in occupational performance, satisfaction, and self-rated health from baseline to post-intervention and six-month follow-up
  2. How do cognitive functions, such as attention and executive functions, correlate with rehabilitation outcomes?

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.

Conditions
PostCovid
Being tested
Interprofessional cognitive group rehabilitation
Keywords
Rehabilitation, Everydays occupations, Health, Life satisfaction
Medical subject headings
Personal Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interprofessional cognitive group rehabilitationOther

    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.

Study groups in NCT07821385
Study groupRoleWhat they receive
Patients with Post-COVID conditionThe study aims to investigate a cohort of patients with post COVID condition whose primary symptoms are cognitive impairment and fatigue. The patients have undergone a comprehensive assessment by a multiprofessional team and have been deemed both to require and to be capable of participating in an on site interprofessional rehabilitation program conducted one day per week.
Receives: Other: Interprofessional cognitive group rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Canadian Occupational Performance Measure (COPM)

    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

    Measured: Before, after and at six months follow-up

Secondary outcomes (6)
  1. EQ5D

    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)

    Measured: Before, after and at six month follow-up

  2. HADS

    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.

    Measured: Before, after and six month follow-up

  3. Rand-36

    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.

    Measured: Before, after and a six months follow-up

  4. MFI-20

    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).

    Measured: Before, after and at six months follow-up

  5. ISI

    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

    Measured: Before, after and at six month follow-up

  6. WHODAS-12

    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

    Measured: Before, after and at six month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2026
  2. Study start20 Aug 2021
  3. Primary completion15 Jan 2026
  4. Study completion15 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
120 participants (actual)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07821385
Sponsor's protocol ID
222333
Acronym
Post-COVID
Status last verified
Sep 2026
First submitted
10 Sep 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data might be shared on request.

Publications

  • Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

    PubMed 11438246
  • Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25. doi: 10.1016/0022-3999(94)00125-o.

    PubMed 7636775
  • Hays RD, Morales LS. The RAND-36 measure of health-related quality of life. Ann Med. 2001 Jul;33(5):350-7. doi: 10.3109/07853890109002089.

    PubMed 11491194
  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PubMed 6880820
  • Balestroni G, Bertolotti G. [EuroQol-5D (EQ-5D): an instrument for measuring quality of life]. Monaldi Arch Chest Dis. 2012 Sep;78(3):155-9. doi: 10.4081/monaldi.2012.121. Italian.

    PubMed 23614330
  • Pollini E, Lazzarini SG, Cordani C, Del Furia MJ, Kiekens C, Negrini S, Arienti C. Effectiveness of Rehabilitation Interventions on Adults With COVID-19 and Post-COVID-19 Condition. A Systematic Review With Meta-analysis. Arch Phys Med Rehabil. 2024 Jan;105(1):138-149. doi: 10.1016/j.apmr.2023.08.023. Epub 2023 Oct 5.

    PubMed 37802177
  • Zeraatkar D, Ling M, Kirsh S, Jassal T, Shahab M, Movahed H, Talukdar JR, Walch A, Chakraborty S, Turner T, Turkstra L, McIntyre RS, Izcovich A, Mbuagbaw L, Agoritsas T, Flottorp SA, Garner P, Pitre T, Couban RJ, Busse JW. Interventions for the management of long covid (post-covid condition): living systematic review. BMJ. 2024 Nov 27;387:e081318. doi: 10.1136/bmj-2024-081318.

    PubMed 39603702
  • Ballouz T, Kerksieck P, Haile SR, Dressel H, Hammig O, Bauer GF, Fehr JS, Puhan MA, Menges D. Work ability trajectories and sick leave in individuals with post COVID-19 condition: 3-year follow-up of a population-based cohort. Lancet Reg Health Eur. 2025 Nov 20;61:101536. doi: 10.1016/j.lanepe.2025.101536. eCollection 2026 Feb.

    PubMed 41362299
  • Kerksieck P, Ballouz T, Haile SR, Schumacher C, Lacy J, Domenghino A, Fehr JS, Bauer GF, Dressel H, Puhan MA, Menges D. Post COVID-19 condition, work ability and occupational changes in a population-based cohort. Lancet Reg Health Eur. 2023 Jun 23;31:100671. doi: 10.1016/j.lanepe.2023.100671. Online ahead of print.

    PubMed 37366496
  • MacEwan SR, Rahurkar S, Tarver WL, Eiterman LP, Melnyk H, Olvera RG, Eramo JL, Teuschler L, Gaughan AA, Rush LJ, Stanwick S, Burpee SB, McConnell E, Schamess A, McAlearney AS. The Impact of Long COVID on Employment and Well-Being: A Qualitative Study of Patient Perspectives. J Gen Intern Med. 2025 Apr;40(5):1070-1077. doi: 10.1007/s11606-024-09062-5. Epub 2024 Oct 8.

    PubMed 39379779
  • Hawke LD, Nguyen ATP, Sheikhan NY, Strudwick G, Rossell SL, Soklaridis S, Kloiber S, Shields R, Ski CF, Thompson DR, Castle D. Swept under the carpet: a qualitative study of patient perspectives on Long COVID, treatments, services, and mental health. BMC Health Serv Res. 2023 Oct 11;23(1):1088. doi: 10.1186/s12913-023-10091-9.

    PubMed 37821939
  • Rosenstein J, Lemhofer C, Loudovici-Krug D, Sturm C, Bokel A. Impact of post-COVID symptoms on activity and participation of women and men. Sci Rep. 2024 Oct 17;14(1):24379. doi: 10.1038/s41598-024-74568-1.

    PubMed 39420197
  • Ottiger M, Poppele I, Sperling N, Schlesinger T, Muller K. Work ability and return-to-work of patients with post-COVID-19: a systematic review and meta-analysis. BMC Public Health. 2024 Jul 7;24(1):1811. doi: 10.1186/s12889-024-19328-6.

    PubMed 38973011
  • Pizarro-Pennarolli C, Sanchez-Rojas C, Torres-Castro R, Vera-Uribe R, Sanchez-Ramirez DC, Vasconcello-Castillo L, Solis-Navarro L, Rivera-Lillo G. Assessment of activities of daily living in patients post COVID-19: a systematic review. PeerJ. 2021 Apr 6;9:e11026. doi: 10.7717/peerj.11026. eCollection 2021.

    PubMed 33868804
  • Zakia H, Pradana K, Iskandar S. Risk factors for psychiatric symptoms in patients with long COVID: A systematic review. PLoS One. 2023 Apr 7;18(4):e0284075. doi: 10.1371/journal.pone.0284075. eCollection 2023.

    PubMed 37027455

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in