Official Title
Study on the Effect of Incentive Spirometer-based Respiratory Training on the Long COVID-19 Symptoms in Chronic Disease Patients After Recovery From COVID-19
Brief Summary

The COVID-19 pandemic has emerged as the most significant public health crisis of the21st century. As of the end of January 2023, global confirmed cases have exceeded 670million, with a domestic cumulative total of 10.24 million cases, including occurrencesof reinfection. Beyond acute symptoms following infection, patients and society face thechallenge of long-term complications associated with COVID-19. Termed 'Post COVID-19condition' or 'Long COVID' by the World Health Organization (WHO), this encompassessymptoms appearing within three months of the initial infection. Symptoms of Long COVIDreveal chronic damage inflicted by the virus on multiple organ systems, includingfatigue, cognitive impairment, chest tightness, palpitations, difficulty breathing, anddepression.Despite continuous efforts by healthcare professionals to find suitable treatments, nomedication has been confirmed to effectively prevent or reduce post-COVID-19 sequelae.These health issues impose significant burdens and disturbances on patients' quality oflife, economies, and societies.

Detailed Description

According to the Ministry of Health and Welfare's report on the top 10 causes of death in
the 111th year, aside from the marked increase in COVID-19 cases, there have been
significant increases in hypertensive diseases, Cardiac diseases, and diabetes
.Therefore, addressing the post-COVID-19 sequelae among chronic disease patients is an
essential global health issue in the post-pandemic era.

Current research indicates that respiratory training is safe and effective in improving
the exercise capacity, lung function, and alleviating respiratory difficulties in
COVID-19 recovered patients. The impact of respiratory training on patients' respiratory
and physical function remains uncertain, especially considering that many present-day
infections are among non-hospitalized individuals with mild symptoms. Thus, exploring
simple and effective respiratory training methods to reduce COVID-19's long-term impact
on patients warrants continuous investigation.

Therefore, this study will employ Incentive spirometer-based respiratory training to
assist COVID-19 patients who has diabetes, hypertensive disease, or cardiac disease in
respiratory training. Data collection before and after the intervention will involve
oxygen demand, blood parameters, the post-COVID-19 Functional Status scale (PCFS scale),
and lung function indices, to investigate and evaluate the effectiveness of intervention
respiratory training in improving Long COVID symptoms.

Not yet recruiting
COVID-19 Pandemic
Diabetes
Hypertension
Cardiac Disease
Long Covid

Behavioral: Incentive Spirometer respiratory training

The 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.

Eligibility Criteria

Inclusion Criteria:

1. 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.

2. 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).

3. 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.

4. Aged between 20 - 90 years.

5. Able to communicate in and understand Mandarin or Taiwanese, either verbally or
non-verbally.

6. Willing to participate in the study and agree to be assigned.

Exclusion Criteria:

1. Patients with a functional status classified as level 5 or higher on the Modified
Rankin Scale (MRS), indicating severe disability and bedridden status.

2. Patients suffering from dementia, such as Alzheimer's, Parkinson's disease, etc.

3. Patients with acute psychiatric symptoms who are unable to communicate.

4. Individuals with a high risk of litigation.

5. Patients suffering from Chronic Obstructive Pulmonary Disease (COPD) or any other
respiratory system diseases.

6. Patients with moderate or severe heart disease, classified as Class III or IV by the
New York Heart Association functional classification.

-

Eligibility Gender
All
Eligibility Age
Minimum: 20 Years ~ Maximum: 90 Years
Locations

Not Provided

Not Provided

Tri-Service General Hospital
NCT Number
Keywords
Covid-19
Post-Acute COVID-19 Syndrome
Long COVID-19
respiratory training
Hypertensive diseases
Cardiac diseases
Diabetes
dyspnea
Incentive Spirometer
MeSH Terms
COVID-19
Post-Acute COVID-19 Syndrome
Heart Diseases