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NCT05877534

Effects of Individual Tailored Physical Exercise in Patients With POTS After COVID-19 - a Randomized Controlled Study

ENROLLING BY INVITATION NA Last updated 9 December 2024
What this trial tests

NA trial testing Individual tailored exercise in Postural Orthostatic Tachycardia Syndrome in 60 participants. Enrolling by invitation.

Timeline
25 May 2023
Primary endpoint
1 March 2026
1 June 2026

Quick facts

Lead sponsorKarolinska Institutet
PhaseNA
StatusENROLLING BY INVITATION
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment60
Start date25 May 2023
Primary completion1 March 2026
Estimated completion1 June 2026
Sites1 location across Sweden

Drugs / interventions tested

Conditions studied

Sponsor

Karolinska Institutet

Who can join

18 and older, any sex, with Postural Orthostatic Tachycardia Syndrome or COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. The term post COVID-19 condition (defined by WHO) is used to describe the wide range of prolonged symptoms following the infection. Patients may need specialized rehabilitation to be able to meet the complex symptoms and problems that may arise. A more specific syndrome that seems to occur more frequently than expected in the group of non-hospitalized patients with post COVID-19 condition is the postural orthostatic tachycardia syndrome (POTS). 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Postural Orthostatic Tachycardia Syndrome

Currently open trials in the same condition.

Other Karolinska Institutet trials

Trials by the same sponsor.

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Data sources for this page

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