Study on Post-Acute COVID-19 Syndrome in Improvement of COVID-19 Rehabilitated Patients by Respiratory Training

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Dyspnea; Post-Acute COVID-19 Syndrome; Incentive Spirometer
• Intervention / Treatment: Device: breathing training

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan, 105309
    • Tri Service General Hospital Sonshan Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Experimental; Patients who have recovered from COVID-19
Experimental: Three months after recovering from COVID-19; Patients who have from COVID-19 in three months	Device: breathing training; Breathing training for six weeks.; Other Names: Incentive Spirometer
Experimental: Six months after recovering from COVID-19; Patients who have from COVID-19 in three to six months	Device: breathing training; Breathing training for six weeks.; Other Names: Incentive Spirometer
Experimental: Nine months after recovering from COVID-19; Patients who have from COVID-19 in six to nine months	Device: breathing training; Breathing training for six weeks.; Other Names: Incentive Spirometer
Experimental: Twelve months after recovering from COVID-19; Patients who have from COVID-19 in nine to twelve months	Device: breathing training; Breathing training for six weeks.; Other Names: Incentive Spirometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen requirements, blood draw values	Oxygen requirements, blood draw values	6 WEEKS

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital
• Investigators: Principal Investigator: Yao-Hsiang Chen, Tri Service General Hospital Sonshan Branch

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: December 9, 2023
• First Submitted That Met QC Criteria: December 9, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Post-Infectious Disorders; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Disease; Lung Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Signs and Symptoms, Respiratory; COVID-19; Post-Acute COVID-19 Syndrome; Syndrome; Dyspnea
• Other Study ID Numbers: A202305044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No