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NCT05225688

Skeletal Muscle in PASC and ME/CFS Patients

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

View on ClinicalTrials.gov

Summary

Rationale: A common feature in patients with Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) and Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) are skeletal muscle-related symptoms, such as muscle pain, weakness, fatigue and post-exertional malaise. Objective: The primary aim is to determine markers for skeletal muscle structure and function, and circulating factors, in patients with PASC and ME/CFS, and compare with controls. The secondary objective is to determine skeletal muscle structure and function before and after induction of post-exertional malaise, and assess the relationships between the measures obtained from muscle biopsies and parameters of exercise tolerance. Study design: Case-control observational study Study population: Patients with PASC, ME/CFS and healthy human volunteers, 18 - 65 yr old. Intervention (if applicable): none Main study parameters/endpoints: Primary outcome parameters are markers for local inflammation, viral infiltration, mitochondrial respiratory function and myokine concentrations in a muscle biopsy and venous blood before and after induction of post-exertional malaise. Heart rate variability and measures of exercise performance will also be determined. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants will be asked to perform physical exercise tests, give muscle biopsies (2 samples), and various blood samples. There is some extent of burden and risk associated with harvesting muscle biopsies and blood samples, however this will be mitigated by the fact that these procedures will only be carried out by trained physicians. Moreover, the scientific gain from obtaining intracellular information outweighs these relatively quick procedures with minimal discomfort afterwards. The acute risks of the physical exercise measurements are negligible. The main risk for patients is that these patients often suffer from post-exertional malaise, which causes the participants to feel fatigued for some time after the maximal exercise test. It is one of the aims to better understand post-exertional malaise.

Official title: Skeletal Muscle Structure and Function in Relation to Post-exertional Malaise in Patients With PASC and ME/CFS

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

Start Date

2022-01-03

Completion Date

2025-12-01

Last Updated

2024-08-06

Healthy Volunteers

Yes

Conditions

LONG-COVID Post-acute Sequelae of COVID-19 ME/CFS

Interventions

BEHAVIORAL

Bike exertion test

maximal exercise test

Inclusion criteria In order to be eligible to participate in this study, a subject with PASC must meet all of the following criteria: * Non-hospitalized individuals with prior confirmed diagnosis of severe acute respiratory coronavirus 2 (SARS-CoV-2) infection by reverse transcription-polymerase chain reaction testing or serology (wantai) testing * Individuals with diagnosed PASC by a post-covid physician * \>3 months of symptoms * Post exertional malaise, according to the DSQ-PEM questionnaire or 1:1 interview with post-covid physician * No symptoms present before confirmed diagnosis of severe acute respiratory coronavirus 2 * Aged between 18-65 years In order to be eligible to participate in this study, a subject with ME/CFS must meet all of the following criteria: * Fulfill the Canadian Consensus Criteria (CCC) * Post exertional malaise, according to the DSQ-PEM questionnaire or 1:1 interview with post-covid physician * \>3 months of symptoms * Aged between 18-65 years * Confirmed diagnosis of severe acute respiratory coronavirus2 (SARS-CoV-2) infection by reverse transcription-polymerase chain reaction testing or serology (wantai) testing For the healthy controls: * Aged between 18-65 years * Confirmed diagnosis of severe acute respiratory coronavirus2 (SARS-CoV-2) infection by reverse transcription-polymerase chain reaction testing or serology (wantai) testing without admission Exclusion criteria A potential subject who meets any of the following criteria will be excluded from participation in this study: * History of asthma, stroke, chronic obstructive pulmonary disease, congestive heart failure, heart surgery, or congenital heart diseases * Severe illness (e.g., active malignancy, CHD, uncontrolled diabetes) * Current treatment with drugs known to interfere with metabolism e.g. systemic corticosteroids, statins, SGLT2 inhibitors, GLP1 receptor agonists or immune modulatory drugs in the last three months. * Severe psychiatric or mood disorders * Insulin pump therapy * Symptomatic autonomic or distal neuropathy * BMI \>35 due to adiposity, since this is known to cause difficulties in obtaining muscle biopsies. * Pregnancy * Recent acute myocardial infarction (\<6 months) * Uncontrolled arrhythmia/severe conduction disorder (atrial fibrillation or second/third degree AV block) causing hemodynamic compromise * Implantable pacemaker or other cardiac device with complete ventricular pacing * Uncontrolled heart failure with hemodynamic compromise * Uncontrolled hypertension (Systolic Blood Pressure \>150 mmHg and Diastolic Blood Pressure \> 100 mmHg on repeated measurements) * Active infection, anaemia, severe renal dysfunction (estimated Glomerular filtration rate \<30 ml/min/1,73m2) likely to significantly impact on exercise performance * Chronic illness (including orthopaedic, endocrinological, haematological, malignant, gastrointestinal, neurological, muscle or inflammatory disorders) likely to significantly impact on exercise performance * \> 6 alcohol units per day or \>14 alcohol units per week * Use of anticoagulants or anti platelet therapy For the healthy controls: ● Individuals hospitalized in the last 6 months (i.e. after SARS-CoV-2 infection).

Locations (1)

Amsterdam university medical centre AMC

Amsterdam, North Holland, Netherlands