Clinical trial NCT06165835: Study on Post-Acute COVID-19 Syndrome in Improvement of COVID-19 Rehabilitated Patients by Respiratory Training
Official title: Study on Post-Acute COVID-19 Syndrome in Improvement of COVID-19 Rehabilitated Patients by Respiratory Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Post-Acute COVID-19 Syndrome
Dyspnea
Incentive Spirometer
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Since the emergence of Corona Virus Disease 2019(COVID-19), it has spread rapidly around the world, And it has had a profound impact on the lives and health of people around the world, most of the COVID-19 positive patients are 3-4 weeks after the onset of infection patients can turn negative and recover, however, increasing observational data suggest that these patients long-term or recurring symptoms such as: fatigue, palpitations, cognitive impairment, dyspnea, anxiety, chest tightness and Pain, etc., symptoms may last at least two months or even longer (for example, up to 12 months), the patient's quality of life and The ability to work and social activities also decline accordingly. Therefore, in addition to the acute symptoms after infection, patients also face the same. The challenge of long-term health sequelae associated with COVID-19.

Detailed description: Relevant studies have shown that breathing training can improve the exercise capacity, lung function, and respiratory rate of patients who have recovered from COVID-19. Difficult and other aspects are safe and effective. However, because COVID-19 is an emerging disease, the clinical research literature so far has limited Clinical data are still insufficient, and the effect of respiratory training on the breathing and physical function of COVID-19 patients has not been determined, and most of the patients are not living in the hospital. How to carry out simple and effective breathing training to reduce the long-term impact of COVID-19 on patients is worthy of continuous discussion. This study will assist COVID-19 patients to perform respiratory training with incentive spirometer intervention, and collect patients before and after the intervention Oxygen requirements, blood draw values and Post-COVID-19 Functional Status scale(PCFS scale) and other data to explore and evaluate the effect of interventional breathing training on the improvement of symptoms of new coronary pneumonia, as a reference for future clinical treatment and improvement of symptoms of COVID-19.

Eligibility criteria: Inclusion Criteria:

1. Patients who have recovered from COVID-19

Exclusion Criteria:

1. Have suffered from within one year. Those who have recovered from COVID-19 must present proof of diagnosis, such as a medical certificate or screening results, etc., and ICD10 when seeking medical treatment The diagnostic codes are: U07.1 Confirmed COVID-19 virus infection, U09.0 Severe specific infectious pneumonia (COVID-19), unspecified.
2. adult, aged 20-90
3. conscious mind and behavior normal mental state examination (Mini-Mental State Examination, MMSE) score \> 21 points.
4. Those who can communicate in verbal or non-verbal ways and understand Chinese and Taiwanese.
5. are willing to participate in the research and agree to accept random machine dispatcher

Primary outcomes:
measure: Oxygen requirements, blood draw values
timeFrame: 6 WEEKS
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Tri Service General Hospital Sonshan Branch
Study officials:
affiliation: Tri Service General Hospital Sonshan Branch
name: Yao-Hsiang Chen
role: PRINCIPAL_INVESTIGATOR
References: