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ChiCTR; 2024-02-23; TrialID: ChiCTR2400081132
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2400081132
ABSTRACT
Condition:
Long CovidIntervention:
healthy group:Maintain daily habits;Rehabilitation group:Maintain daily habits;fatigue patients with Long Covid:Maintain daily habits;Primary outcome:
Peak cardiorespiratory oxygen uptake;Proteomic features;Metabolomics profile;Criteria:
Inclusion criteria: 1. Inclusion criteria for healthy populations(1) No history of novel coronavirus infection and SARS infection or morbidity
(2) 18 years = age = 80 years
(3) Those who can perform exercise cardiopulmonary testing
(4) Able to read and understand the contents of the informed consent form, sign the informed consent form and voluntarily participate
(5) Axillary temperature <37.3?
(6) No history of allergy to vaccine exposure
(7) Non-pregnant or lactating women
(8) No history of immune system diseases, other serious diseases or mental illnesses
(9) Ability to comply with vaccination and blood sample collection procedures, obey the management of the study center, and return to the study center for follow-up visits on time
2. Inclusion criteria for persons recovering from novel coronavirus infection
(1) Positive polymerase chain reaction (PCR) test or antigen results for novel coronaviruses and no sequelae such as fatigue or malaise 12 weeks after the diagnosis of COVID-19
(2) 18 years = age = 80 years
(3) Those who can perform exercise cardiopulmonary testing
(4) Able to read and understand the contents of the informed consent form, sign the informed consent form and voluntarily participate
(5) Axillary temperature <37.3?
(6) No history of allergy to vaccine exposure
(7) Non-pregnant or lactating women
(8) No history of immune system diseases, other serious diseases or mental illnesses
(9) Ability to comply with vaccination and blood sample collection procedures, obey the management of the study center, and return to the study center for follow-up visits on time
3. Long Covid with Fatigue Patient Inclusion Criteria
(1) Positive polymerase chain reaction (PCR) test or antigen results for novel coronaviruses with sequelae such as fatigue and malaise 12 weeks after diagnosis of COVID-19
(2) 18 years = age = 80 years
(3) Those who can perform exercise cardiopulmonary testing
(4) Able to read and understand the contents of the informed consent form, sign the informed consent form and voluntarily participate
(5) Axillary temperature <37.3?
(6) No history of allergy to vaccine exposure
(7) Non-pregnant or lactating women
(8) No history of immune system diseases, other serious diseases or mental illnesses
(9) Ability to comply with vaccination and blood sample collection procedures, obey the management of the study center, and return to the study center for follow-up visits on time
Exclusion criteria: Subjects with the following conditions should be excluded:
(1) Pulmonary embolism;
(2) Absolute and relative contraindications to cardiopulmonary exercise testing or exercise training;
(3) Obvious arrhythmia or ischemia during low-intensity exercise and severe pulmonary hypertension;
(4) Severe pulmonary diseases (e.g., chronic obstructive pulmonary disease, severe COVID-19-related symptoms, severe asthma);
(5) Recent cardiovascular events (cardiac decompensation, angioplasty or cardiac surgery less than 4 weeks, valvular heart disease requiring surgical correction, pericarditis, fatigue caused by various arrhythmias);
(6) Renal failure requiring dialysis;
(7) Patients with New York Heart Association (NYHA) class ? or recurrent malignant arrhythmia;
(8) Drug-induced muscle atrophy, such as steroids or neuromuscular blocking drugs;
(9) Metabolic diseases ( such as hyperglycemia, malnutrition), and weakness caused by electrolyte disturbances;
(10) Myalgic encephalomyelitis/chronic fatigue syndrome;
(11) Allergic to known components of study drugs;
(12) Refusal to sign informed consent;
(13)Those who participated in other clinical trials or used Chinese medicine (proprietary Chinese medicine) in the last three months.