Clinical trial NCT05445830: Exercise Intolerance in Post-COVID Patients
Official title: Physiological Characterization of Functional Limitations and Exercise Intolerance in Post-COVID Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Post-COVID Syndrome
Keywords: Exercise intolerance
Acute exercise
Skeletal muscle
Cardiorespiratory fitness
Post-COVID syndrome
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2022-07-06
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Post-exertional malaise (PEM) symptoms of post-COVID subjects and age/sex matched controls in response to different exercise trials.
timeFrame: Three exercises trials & 48 hours follow-ups of each trial
Secondary outcomes:
measure: Absolute immune cell count in blood samples of post-COVID subjects and age/sex matched controls in response to different exercise trials.
timeFrame: Three exercises trials & 48 hours follow-ups of each exercise trial
measure: Exploratory metabolomic and cytokine profiling using blood samples of post-COVID subjects and age/sex matched controls in response to different exercise trials.
timeFrame: Three exercises trials & 48 hours follow-ups of each exercise trial
measure: Cardiac function in the post-COVID subjects and age/sex matched controls
timeFrame: Baseline & 1y follow-up
measure: Respiratory function in the post-COVID subjects and age/sex matched controls
timeFrame: Baseline & 1y follow-up
measure: Arterial stiffness in the post-COVID subjects and age/sex matched controls
timeFrame: Baseline & 1y follow-up
measure: Dysautonomia in the post-COVID subjects and age/sex matched controls
timeFrame: Baseline & 1y follow-up
measure: 6-min walk test the post-COVID subjects and age/sex matched controls
timeFrame: Baseline & 1y follow-up
measure: Handgrip strength the post-COVID subjects and age/sex matched controls
timeFrame: Baseline & 1y follow-up
measure: Blood volume in the post-COVID subjects and age/sex matched controls
timeFrame: Baseline & 1y follow-up
measure: Lower body muscle strength the post-COVID subjects and age/sex matched controls
timeFrame: Baseline & 1y follow-up
measure: Nerve conduction studies the post-COVID subjects and age/sex matched controls
timeFrame: Baseline & 1y follow-up
measure: Needle Electromyography in the post-COVID subjects and age/sex matched controls
timeFrame: Baseline & 1y follow-up
measure: Sympathetic skin response in the post-COVID subjects and age/sex matched controls
timeFrame: Baseline & 1y follow-up
measure: Heart rate variability in the post-COVID subjects and age/sex matched controls
timeFrame: Baseline & 1y follow-up
measure: Muscle biopsy in the post-COVID subjects and age/sex matched controls
timeFrame: Baseline & 1y follow-up
measure: Exercise (in)capacity of post-COVID subjects and age/sex matched controls
timeFrame: Baseline & 48 hours follow-ups of each trial & 1y follow-up
measure: Post-exertional symptoms using the Multifactional Fatigue Inventory (MFI) in post-COVID subjects and age/sex matched controls in response to different exercise trials.
timeFrame: Three exercises trials & 48 hours follow-ups of each trial
measure: Post-exertional symptoms using the Profile of Mood States (POMS) in post-COVID subjects and age/sex matched controls in response to different exercise trials.
timeFrame: Three exercises trials & 48 hours follow-ups of each trial
measure: Post-exertional symptoms using the Somatic and Psychological Health REport (SPHERE) instrument in post-COVID subjects and age/sex matched controls in response to different exercise trials.
timeFrame: Three exercises trials & 48 hours follow-ups of each trial
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Huddinge
state: Huddinge
Study officials:
affiliation: Karolinska Institutet and Karolinska University Hospital
name: Thomas Gustafsson, Prof
role: STUDY_CHAIR
affiliation: Karolinska Institutet
name: Helene Rundqvist, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Tommy Lundberg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hospital
name: Kaveh Pourhamidi, PhD
role: STUDY_CHAIR
affiliation: Karolinska Institutet
name: Andrea Tryfonos, PhD
role: STUDY_DIRECTOR
References: