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ENROLLING BY INVITATION
NCT05877534
NA

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

Sponsor: Karolinska Institutet

View on ClinicalTrials.gov

Summary

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.

Official title: Effects of Individual Tailored Physical Exercise in Patients With Post COVID-19 Condition, Diagnosed With Postural Orthostatic Tachycardia Syndrome (POTS) - a Randomized Controlled Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-05-25

Completion Date

2026-06-01

Last Updated

2024-12-09

Healthy Volunteers

No

Interventions

OTHER

Individual tailored exercise

A 16 week period of progressive exercise, supervised by a physiotherapist once a week.

Locations (1)

Karolinska University Hospital

Stockholm, Sweden