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

NCT05877534 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-09

No results posted yet for this study

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.

Conditions

  • Postural Orthostatic Tachycardia Syndrome
  • COVID-19
  • Post COVID-19 Condition
  • Post-Acute COVID-19 Syndrome

Interventions

OTHER

Individual tailored exercise

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

Sponsors & Collaborators

Principal Investigators

  • Malin Nygren-Bonnier, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-25
Primary Completion
2026-03-01
Completion
2026-06-01

Countries

  • Sweden

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05877534 on ClinicalTrials.gov