Exercise Intolerance in Post-COVID Patients

NCT05445830 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-09-03

No results posted yet for this study

Summary

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.

Conditions

  • Post-COVID Syndrome

Interventions

PROCEDURE

High-Intensity-Interval-Exercise

Subjects will perform high-intensity-interval exercise, where the acute exercise responses will be closely monitored, including measurements of O2 saturation, heart rate, blood pressure, borg scale and blood lactate. In addition, symptoms via multiple validated questionnaries and blood samples will be collected before, immediately after each exercise session to describe leukocyte and cytokine release as well as systemic metabolism. After a 48-hour rest period subjects will return to the laboratory for symptom assessment, submaximal exercise response (CPET), and blood sampling.

PROCEDURE

Moderate-Intensity-Continuous-Exercise

Subjects will perform moderate intensity continuous exercise, where the acute exercise responses will be closely monitored, including measurements of O2 saturation, heart rate, blood pressure, borg scale and blood lactate. In addition, symptoms via multiple validated questionnaries and blood samples will be collected before, immediately after each exercise session to describe leukocyte and cytokine release as well as systemic metabolism. After a 48-hour rest period subjects will return to the laboratory for symptom assessment, submaximal exercise response (CPET), and blood sampling.

PROCEDURE

Strength training

Subjects will perform a series of a whole-body resistance exercises, where the acute exercise responses will be closely monitored, including measurements of O2 saturation, heart rate, blood pressure, borg scale and blood lactate. In addition, symptoms via multiple validated questionnaries and blood samples will be collected before, immediately after each exercise session to describe leukocyte and cytokine release as well as systemic metabolism. After a 48-hour rest period subjects will return to the laboratory for symptom assessment, submaximal exercise response (CPET), and blood sampling.

PROCEDURE

Baseline assessment

Subjects will perform a series of baseline assessment including neurophysiological function, circulatory and vascular function, blood volume assessment, respiratory/ventilatory function, maximal oxygen uptake, strength, physical function and fitness, blood status and muscle biopsy.

PROCEDURE

1 year follow-up

Subjects will perform the same series of baseline assessment in 1-year time, including neurophysiological function, circulatory and vascular function, blood volume assessment, respiratory/ventilatory function, maximal oxygen uptake, strength, physical function and fitness, blood status and muscle biopsy.

Sponsors & Collaborators

Principal Investigators

  • Thomas Gustafsson, Prof · Karolinska Institutet and Karolinska University Hospital

  • Helene Rundqvist, PhD · Karolinska Institutet

  • Tommy Lundberg, PhD · Karolinska Institutet

  • Kaveh Pourhamidi, PhD · Karolinska University Hospital

  • Andrea Tryfonos, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-09-15
Completion
2025-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

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 NCT05445830 on ClinicalTrials.gov