Effects of Individual Tailored Physical Exercise in Patients With POTS After COVID-19 - a Randomized Controlled Study
NCT ID: NCT05877534
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
NA
60 participants
INTERVENTIONAL
2023-05-25
2026-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
A randomized controlled design will be used to evaluate the effects of individual tailored physical exercise in patients with POTS after Covid-19.
Participants: Adults (\>18 years) with post COVID-19 condition and diagnosed with POTS (n=60) will be included. Exclusion criteria: known pregnancy, cancer, already ongoing individual physical exercise (specific for POTS), or not able to perform measurements and/or intervention.
Procedure and outcomes: The primary outcomes are objectively measured time in upright position and health-related quality of life. Secondary outcomes are: physical activity, physical capacity, work ability and disease specific symptoms measured with tests and questionnaires.
Prior to randomization baseline measurements will be performed, aswell as after 16 weeks, 6 months and 12 months.
Intervention: Participants randomized to intervention will receive standard care and undergo a individually designed physical exercise program during 16 weeks, supervised and guided by a physiotherapist. The intervention will consist of different exercises to enhance muscle strength and endurance. Progression will be according to a program (based on previous feasibility studie) but should be halted if post exertional malaise (PEM) or other problems occur.
Controls: Participants randomized to control will receive standard care during 16 weeks.
Measurements of both groups (control and intervention) will be repeated after completion of a period of 16 weeks.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Covid-19, was in March 2020, declared a global pandemic by the World Health Organization (WHO). In August 2021, in Sweden, over 1 100 000 cases were confirmed and over 14 000 deaths. Initially, it was suspected that Covid-19 would primarily affect the airways, but several studies have now shown that it is a disease with multisystem manifestations. The impact of the virus ranges from an asymptomatic infection to a severe and life-threatening disease that can affect the cardiac, renal gastrointestinal, nervous, endocrine, and musculoskeletal systems. Therefore, Covid-19 has the potential to affect physical, cognitive, and psychological functions in multiple ways.
It has been clear that a significant proportion of patients with Covid-19 develop long-term symptoms. Signs and symptoms may arise from any system in the body, often with significant overlap, and may develop over time. The term post COVID-19 condition (defined by WHO) is now used to describe the wide range of prolonged symptoms following the infection. Fatigue, decreased physical and psychological function have been reported in the initial recovery phase, but still little is known on the long-term consequences. Previous studies on the recovery and rehabilitation after other coronavirus shows the importance to develop tailored interventions.
A more specific syndrome that seems to occur more frequently in non-hospitalized persons with post COVID-19 condition is the postural orthostatic tachycardia syndrome (POTS). It is a chronic orthostatic intolerance where upright posture is associated with an excessive increase in heart rate (HR) and associated symptoms, such as palpitation, exercise intolerance, hypermobile joints, migraine headaches, brain-fog, sleep disturbances, and fatigue. Symptoms can be exacerbated by simple activities of daily life and the patients often report a low quality of life, equivalent to what patients with severe heart failure or COPD report. Consequently, patients seem to reduce their physical activity, which make them deconditioned and limits the activities in daily living even more.
Nevertheless, supervised individual tailored physical exercises, is a recommended non-pharmacological treatment of POTS. However, few studies have investigated the effect of physical exercise in POTS, and studies of POTS and post COVID-19 condition are very sparse. Therefore a feasibility study were performed and data found that the intervention (individually tailored physical exercise) was feasible in terms of safety, recruitment and compliance. Moreover the feasibility study provided optimistic results of the effects according to the participants physical, psychological functions as to their quality of life.
The planned RCT is part of research project (ReCOV), integrated with the clinical follow-up at Karolinska University Hospital and linked research project of patients who have been hospitalized or refereed to the clinic from primary care. The hypothesis is that an individually tailored rehabilitation program will have a beneficial effect on the ability to spend time in an upright position, as well as on HRQoL, for individuals with POTS, post COVID-19 condition.
The overall aim of this study is to evaluate the effects of an individually tailored exercise and its impact on time spent in upright position and health-related quality of life (HRQoL), physical activity, physical and psychological function and work-ability in persons with POTS, post COVID-19 condition.
Methods
Participants:
A total of 60 adult patients (\>18 years) with POTS (diagnosed by a cardiologist), post COVID-19 condition. Recruitment will take place at the outpatient clinic at Karolinska University Hospital or in the primary care in Region Stockholm. Exclusion criteria: known pregnancy, cancer, already ongoing individual physical exercise (specific for POTS) or not able to perform measurements and/or intervention.
Procedure:
Prior to randomization baseline measurements will be performed. The measurements include Active Standing (AST), Test, 6-minute Walk Test (6MWT), muscle strength with MicroFET, measurements of pulsoximetry, pulse and blood pressure before, during and after tests, and participant will report their symptoms with BORG CR10 and BORG RPE. To evaluate time in upright position participants will wear two accelerometers (ActivPAL) during a week before intervention start. Questionnaires that will be used are EQ-5D-5L, Vanderbuildt Orthostatic Symptom Scale (VOSS), Malmö POTS Symptom Scale (MaPS), Fatigue Severeity Scale (FSS), Mental Fatigue Scale (MFS), DePaul Symtom Questionnaire - Post-Exertion Malaise (DSQ-PEM), Generalized Anxiety Disorder 7-item scale (GAD-7), Patient Health Questionnaire (PHQ-9) and Insomnia Severeity Index (ISS).
Controls: Participants randomized to control will receive standard care during 16 weeks. Standard care includes (but not restricted to) information about POTS and lifestyle changes that may effect the symptoms, advice about what fluid intake and nutrition, compression garments, pharmacological interventions etc.
Intervention: Participants randomized to intervention will receive standard care (same as controls) and undergo an individually tailored physical exercise program during a period of 16 weeks. The intervention will consist of exercises to enhance muscle strength and endurance. The program includes progression regarding duration and position for the exercise (starting i laying position and progression towards upright position). Progression should be halted if post exertional malaise (PEM) or other problems occur whitin 24h after exercise. The participants will once a week be supervised and guided individually by a physioherapist. Participants will, on a weekly basis, complete a training diary regarding their physical activity and training intensity in which they report any setbacks or adverse events.
Measurements of both groups (control and intervention) will be repeated after completion of a period of 16 weeks and longitudinal follow-up at 6 and 12 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention
A 16 week period of exercise, supervised by a physiotherapist once a week. The exercise should be individually tailored from a programme based on a previous feasibility study. The program consist of exercises both to improve endurance and muscle strength. Progression and adjustments of time and position will be performed during the intervention period based any symptoms the participant exhibits. Progression should be halted if the participant experience PEM or other symptoms within \>24hours after last exercise. The participants will also recieve standard care during the intervention period. Standard care includes (but not restricted to) information about POTS and lifestyle changes that may effect the symptoms, advice about fluid intake and nutrition, compression garments, pharmacological interventions etc.
Individual tailored exercise
A 16 week period of progressive exercise, supervised by a physiotherapist once a week.
Control
Standard care during 16 weeks. Standard care includes (but not restricted to) information about POTS and lifestyle changes that may effect the symptoms, advice about fluid intake and nutrition, compression garments, pharmacological interventions etc.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Individual tailored exercise
A 16 week period of progressive exercise, supervised by a physiotherapist once a week.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Karolinska University Hospital
OTHER
Karolinska Institutet
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Malin Nygren-Bonnier
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Malin Nygren-Bonnier, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Karolinska University Hospital
Stockholm, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Fu Q, Levine BD. Exercise and non-pharmacological treatment of POTS. Auton Neurosci. 2018 Dec;215:20-27. doi: 10.1016/j.autneu.2018.07.001. Epub 2018 Jul 4.
Crook H, Raza S, Nowell J, Young M, Edison P. Long covid-mechanisms, risk factors, and management. BMJ. 2021 Jul 26;374:n1648. doi: 10.1136/bmj.n1648.
Nalbandian A, Sehgal K, Gupta A, Madhavan MV, McGroder C, Stevens JS, Cook JR, Nordvig AS, Shalev D, Sehrawat TS, Ahluwalia N, Bikdeli B, Dietz D, Der-Nigoghossian C, Liyanage-Don N, Rosner GF, Bernstein EJ, Mohan S, Beckley AA, Seres DS, Choueiri TK, Uriel N, Ausiello JC, Accili D, Freedberg DE, Baldwin M, Schwartz A, Brodie D, Garcia CK, Elkind MSV, Connors JM, Bilezikian JP, Landry DW, Wan EY. Post-acute COVID-19 syndrome. Nat Med. 2021 Apr;27(4):601-615. doi: 10.1038/s41591-021-01283-z. Epub 2021 Mar 22.
Fedorowski A. Postural orthostatic tachycardia syndrome: clinical presentation, aetiology and management. J Intern Med. 2019 Apr;285(4):352-366. doi: 10.1111/joim.12852. Epub 2018 Nov 23.
Johansson M, Stahlberg M, Runold M, Nygren-Bonnier M, Nilsson J, Olshansky B, Bruchfeld J, Fedorowski A. Long-Haul Post-COVID-19 Symptoms Presenting as a Variant of Postural Orthostatic Tachycardia Syndrome: The Swedish Experience. JACC Case Rep. 2021 Apr;3(4):573-580. doi: 10.1016/j.jaccas.2021.01.009. Epub 2021 Mar 10.
Stahlberg M, Reistam U, Fedorowski A, Villacorta H, Horiuchi Y, Bax J, Pitt B, Matskeplishvili S, Luscher TF, Weichert I, Thani KB, Maisel A. Post-COVID-19 Tachycardia Syndrome: A Distinct Phenotype of Post-Acute COVID-19 Syndrome. Am J Med. 2021 Dec;134(12):1451-1456. doi: 10.1016/j.amjmed.2021.07.004. Epub 2021 Aug 11.
Arnold AC, Ng J, Raj SR. Postural tachycardia syndrome - Diagnosis, physiology, and prognosis. Auton Neurosci. 2018 Dec;215:3-11. doi: 10.1016/j.autneu.2018.02.005. Epub 2018 Feb 28.
Benrud-Larson LM, Dewar MS, Sandroni P, Rummans TA, Haythornthwaite JA, Low PA. Quality of life in patients with postural tachycardia syndrome. Mayo Clin Proc. 2002 Jun;77(6):531-7. doi: 10.4065/77.6.531.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RCT-POTS-ReCov
Identifier Type: -
Identifier Source: org_study_id