About this trial
The COVID-19 pandemic has emerged as the most significant public health crisis of the 21st century. As of the end of January 2023, global confirmed cases have exceeded 670 million, with a domestic cumulative total of 10.24 million cases, including occurrences of reinfection. Beyond acute symptoms following infection, patients and society face the challenge of long-term complications associated with COVID-19. Termed 'Post COVID-19 condition' or 'Long COVID' by the World Health Organization (WHO), this encompasses symptoms appearing within three months of the initial infection. Symptoms of Long COVID reveal chronic damage inflicted by the virus on multiple organ systems, including fatigue, cognitive impairment, chest tightness, palpitations, difficulty breathing, and depression.
Despite continuous efforts by healthcare professionals to find suitable treatments, no medication has been confirmed to effectively prevent or reduce post-COVID-19 sequelae. These health issues impose significant burdens and disturbances on patients' quality of life, economies, and societies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals who have contracted and recovered from COVID-19 within the past year must present proof of diagnosis, such as medical certificates or screening results. The ICD-10 diagnosis codes are: U07.1 for confirmed COVID-19 viral infection, and U09.0 for post-COVID-19 condition, unspecified. Recovery is defined as testing negative in a COVID-19 rapid test.
Never diagnosed with hypertensive diseases (ICD-10 codes: I10.x or I11.x), diabetes (ICD-10 codes: E10.x or E11.x), or heart diseases (ICD-10 codes: I25.x, I50.x, I65.x, or I67.x and classified as Class I or II by the New York Heart Association functional classification).
Exhibiting long-term respiratory symptoms related to COVID-19, such as post-exertional breathlessness, chest discomfort, cough, difficulty breathing, rapid breathing, etc., and meeting at least one of these criteria for inclusion.
Aged between 20 - 90 years.
Disqualifiers
Patients with a functional status classified as level 5 or higher on the Modified Rankin Scale (MRS), indicating severe disability and bedridden status.
Patients suffering from dementia, such as Alzheimer's, Parkinson's disease, etc.
Patients with acute psychiatric symptoms who are unable to communicate.
Individuals with a high risk of litigation.
Trial design
Parallel
Treatments tested in this trial
Incentive Spirometer respiratory training
BehavioralThe incentive spirometer is a handheld mechanical breathing device that uses a one-way valve to prevent exhalation. It consists of a corrugated tube and a nozzle connected to three consecutive plastic chambers, each containing a ball. The external chambers are marked with the minimum flow required to raise the ball internally. The ball rises when the patient performs slow, deep breathing through the nozzle. If the patient breathes too quickly, the balls in the chambers rise to the top, and if breathing is too slow, the balls fall to the bottom. The number of increasing balls measures the volume of inhaled air. When all three balls reach the top of the chambers, the patient's flow rate can reach 1200 ml/s. After the patient has maximized their inhalation, they are asked to hold the balls in the same position for more than 3 sec.
Treatment groups
Trial outcomes
Primary outcomes
Post-COVID-19 Functional Status scale
for check the effect of respiratory training
Secondary outcomes
Lung function indices
for check the effect of respiratory training
Hemoglobin and oxygen levels
for check the effect of respiratory training
Six-minute walk test (6MWT)
for check the effect of respiratory training
Dyspnoea-12 (D-12) scale
for check the effect of respiratory training
Locations
Sponsors and contacts
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National Taipei University of Nursing and Health Sciences
Lead sponsor
Tri-Service General Hospital
Collaborator
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