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

NCT ID: NCT06165835

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-12-30

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.

Conditions

COVID-19; Post-Acute COVID-19 Syndrome; Dyspnea; Incentive Spirometer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

Patients who have recovered from COVID-19

Group Type: NO_INTERVENTION

No interventions assigned to this group

Three months after recovering from COVID-19

Patients who have from COVID-19 in three months

Group Type: EXPERIMENTAL

breathing training

Intervention Type: DEVICE

Breathing training for six weeks.

Six months after recovering from COVID-19

Patients who have from COVID-19 in three to six months

Group Type: EXPERIMENTAL

breathing training

Intervention Type: DEVICE

Breathing training for six weeks.

Nine months after recovering from COVID-19

Patients who have from COVID-19 in six to nine months

Group Type: EXPERIMENTAL

breathing training

Intervention Type: DEVICE

Breathing training for six weeks.

Twelve months after recovering from COVID-19

Patients who have from COVID-19 in nine to twelve months

Group Type: EXPERIMENTAL

breathing training

Intervention Type: DEVICE

Breathing training for six weeks.

Interventions

breathing training

Breathing training for six weeks.

Intervention Type: DEVICE

Other Intervention Names

Incentive Spirometer

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tri-Service General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chen, Yao-Hsiang

assistant hand nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yao-Hsiang Chen

Role: PRINCIPAL_INVESTIGATOR

Tri Service General Hospital Sonshan Branch

Locations

Tri Service General Hospital Sonshan Branch

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

A202305044

Identifier Type: -

Identifier Source: org_study_id