Study on the Effect of Incentive Spirometer-based Respiratory Training on the Long COVID-19

NCT06231225 | Not Yet Recruiting

• 1 other identifier: B202305165
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The COVID-19 pandemic has emerged as the most significant public health crisis of the 21st century. As of the end of January 2023, global confirmed cases have exceeded 670 million, with a domestic cumulative total of 10.24 million cases, including occurrences of reinfection. Beyond acute symptoms following infection, patients and society face the challenge of long-term complications associated with COVID-19. Termed 'Post COVID-19 condition' or 'Long COVID' by the World Health Organization (WHO), this encompasses symptoms appearing within three months of the initial infection. Symptoms of Long COVID reveal chronic damage inflicted by the virus on multiple organ systems, including fatigue, cognitive impairment, chest tightness, palpitations, difficulty breathing, and depression. Despite continuous efforts by healthcare professionals to find suitable treatments, no medication has been confirmed to effectively prevent or reduce post-COVID-19 sequelae. These health issues impose significant burdens and disturbances on patients' quality of life, economies, and societies.

Conditions

COVID-19 Pandemic; Diabetes; Hypertension; Cardiac Disease; Long COVID

Keywords

COVID-19; Post-Acute COVID-19 Syndrome; Long COVID-19; respiratory training; Hypertensive diseases; Cardiac diseases; Diabetes; Dyspnea; Incentive Spirometer

Outcome Measures

Primary Outcomes (1)

• Post-COVID-19 Functional Status scale

  for check the effect of respiratory training

  through study completion, an average of 1 year

Secondary Outcomes (4)

• Lung function indices

  through study completion, an average of 1 year

• Hemoglobin and oxygen levels

  through study completion, an average of 1 year

• Six-minute walk test (6MWT)

  through study completion, an average of 1 year

• Dyspnoea-12 (D-12) scale

  through study completion, an average of 1 year

Study Arms (2)

control group

NO INTERVENTION

not assign respiratory training

treatment group

EXPERIMENTAL

assign respiratory training

Behavioral: Incentive Spirometer respiratory training

Interventions

Incentive Spirometer respiratory training BEHAVIORAL

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.

treatment group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).
• Aged between 20 - 90 years.
• Able to communicate in and understand Mandarin or Taiwanese, either verbally or non-verbally.
• Willing to participate in the study and agree to be assigned.

You may not qualify if:

• Patients with a functional status classified as level 5 or higher on the Modified Rankin Scale (MRS), indicating severe disability and bedridden status.
• Patients suffering from dementia, such as Alzheimer's, Parkinson's disease, etc.
• Patients with acute psychiatric symptoms who are unable to communicate.
• Individuals with a high risk of litigation.
• Patients suffering from Chronic Obstructive Pulmonary Disease (COPD) or any other respiratory system diseases.
• Patients with moderate or severe heart disease, classified as Class III or IV by the New York Heart Association functional classification.

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead
• Tri-Service General Hospital: collaborator

MeSH Terms

Conditions

COVID-19; Diabetes Mellitus; Hypertension; Heart Diseases; Post-Acute COVID-19 Syndrome; Dyspnea

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: January 30, 2024
• Study Start: July 1, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share