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ClinicalTrials.gov; 26/01/2024; TrialID: NCT06231225
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06231225
ABSTRACT
Condition:
COVID-19 Pandemic;Diabetes;Hypertension;Cardiac Disease;Long COVIDIntervention:
Behavioral: Incentive Spirometer respiratory trainingPrimary outcome:
Post-COVID-19 Functional Status scaleCriteria:
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.
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