Exercise Intolerance in Post-COVID Patients (EXILE)

Karolinska Institute

Status: Active, not recruiting

Conditions: Post-COVID Syndrome

Treatments: Procedure: High-Intensity-Interval-Exercise; Procedure: Moderate-Intensity-Continuous-Exercise; Procedure: Strength training; Procedure: Baseline assessment; Procedure: 1 year follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT05445830

2021-05758-01

Details and patient eligibility

About

The post-COVID syndrome poses an unprecedented challenge to modern society, affecting millions of people worldwide. Persistent fatigue and exercise intolerance are among the most common complaints of these subjects. The mechanisms of exercise intolerance in post-COVID subjects are remained yet unknown, which make the rehabilitation efforts complex and challenging. The overall goals of this project are to: 1) improve physiological understanding of symptoms in this clinical condition, 2) elucidate plausible mechanisms to explain exercise intolerance/symptom exacerbation, and finally 3) provide knowledge that can be directly applied in the clinical setting to improve diagnosis, care, and individualized rehabilitation of subjects with post-COVID syndrome. Post-COVID subjects and age/sex matched healthy controls will undertake a comprehensive set of physiological and functional assessments, followed by 3 experimental visits (in a randomized order), where acute exercise responses will be assessed in either continuous moderate intensity aerobic exercise, high intensity interval exercise, or strength training. The same set of physiological assessments will also be performed after 1 year in both post-COVID subjects and healthy-matched controls to better understand the time course of the syndrome. It is hypothesized that the mechanism responsible for exercise intolerance is linked to specific symptoms and will vary across subjects. However, it is expected that most post-COVID subjects will respond well to at least one type of exercise.

Enrollment: 62 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Verified test of covid-19 infection (PCR, or antigen or antibody before vaccination) (mandatory only for post-COVID group)
• Symptoms persisting for at least 3 months (validaded with DSQ-PEM questionnarie) (only for post-COVID group)

Exclusion criteria

• Subject's complaints may have been present before March 2020
• Previous history cardiovascular, respiratory disease or other autoimmune disease
• History of general anxiety syndrome or somatic symptom disorder

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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62 participants in 2 patient groups

Post-covid patients

Experimental group

Treatment:

Procedure: 1 year follow-up

Procedure: Baseline assessment

Procedure: Strength training

Procedure: Moderate-Intensity-Continuous-Exercise

Procedure: High-Intensity-Interval-Exercise

Control

Experimental group

Treatment:

Procedure: 1 year follow-up

Procedure: Baseline assessment

Procedure: Strength training

Procedure: Moderate-Intensity-Continuous-Exercise

Procedure: High-Intensity-Interval-Exercise