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临床试验/NCT07185178
NCT07185178招募中不适用

Investigation of the Effect of Video Game-Based Breathing Exercises on Dysfunctional Respiration in Patients With Asthma-COPD Overlap Syndrome (ACOS)

Istinye University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年8月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Capnography

研究概览

简要总结

Asthma and COPD are significant respiratory diseases that can coexist, referred to as Asthma-COPD Overlap Syndrome (ACOS). Patients with ACOS experience more severe clinical outcomes, including rapid decline in lung function, increased symptom burden, and reduced quality of life. Pulmonary rehabilitation-particularly breathing exercises-is a core non-pharmacological intervention recommended for this patient group. In recent years, video game-based applications have emerged as innovative tools that enhance motivation and participation in exercise programs. However, studies investigating the effects of video game-based breathing exercises in ACOS patients are extremely limited. Additionally, although dysfunctional breathing patterns are common in this group, few studies have addressed targeted interventions. The objective of the present study is to evaluate the effects of video game-based breathing exercises on dysfunctional breathing in ACOS patients.

详细描述

Asthma and chronic obstructive pulmonary disease (COPD) are significant public health problems. Asthma is defined as a chronic respiratory disease characterized by airway hyperresponsiveness causing intermittent and usually reversible airway obstruction, whereas COPD is a chronic respiratory disease characterized by progressive and irreversible airway obstruction, typically occurring in individuals over the age of 40 and associated with tobacco use. These definitions allow asthma and COPD to be recognized as distinct diseases. However, many epidemiological studies indicate that asthma and COPD can coexist, or that one condition may progress into the other, a condition referred to as Asthma-COPD Overlap Syndrome (ACOS). According to global guidelines, individuals who are generally aged 40 years or older, have a history of smoking at least five pack-years or biomass exposure, have a medical history of asthma or allergy, and show a post-bronchodilator FEV₁ increase of typically 12% and 200 mL are considered to have ACOS. Compared to patients with asthma or COPD alone, those with ACOS tend to experience more frequent exacerbations, rapid decline in lung function, and reduced health-related quality of life. These factors contribute to higher mortality rates among ACOS patients. Reports indicate that ACOS patients experience more dyspnea, higher comorbidity indices, more frequent hospitalizations, and higher BODE indices. Functional exercise capacity has also been found to be lower in this group.

A review of the literature suggests pulmonary rehabilitation as a non-pharmacological treatment method for ACOS patients. Breathing exercises, forming the basis of pulmonary rehabilitation, aim to reduce dyspnea and hyperinflation, improve respiratory muscle performance, and optimize thoraco-abdominal movement by regulating respiratory muscle activation and patterns. The most commonly used breathing exercises include deep diaphragmatic and segmental breathing exercises (also known as breathing control), pursed-lip breathing, and thoracic expansion exercises. Pulmonary rehabilitation applied to individuals with ACOS has been reported to improve functional capacity and BODE index, reduce dyspnea and symptom scores, and contribute to improved lung function. Studies investigating the effectiveness of pulmonary rehabilitation have shown significant improvements in six-minute walk distance, BODE index, and quality-of-life questionnaire results. In COPD and ACOS patients, significant improvements have been observed after training in lung function, six-minute walk test distance, peripheral and inspiratory muscle strength, activities of daily living, and quality-of-life scores. Considering the clinical course, further research is necessary to develop personalized pulmonary rehabilitation programs for ACOS patients.

No studies have been found applying video game-based exercise programs specifically for ACOS patients. Initially incorporated only into exercise training programs, these digital applications have recently been integrated into respiratory exercise regimens due to technological advancements and have been established in the literature as comprehensive, effective, and innovative treatment approaches for respiratory diseases. With advantages such as increasing patient motivation, interest, exercise adherence, and active participation while making exercises more enjoyable, video game-based exercise applications are recognized as effective and beneficial methods. Nonetheless, video game-based respiratory exercise applications remain extremely limited. The current research project implements video game-based breathing exercises in ACOS patients for the first time.

Studies indicate that dysfunctional breathing patterns are common in patients with asthma and COPD. Dysfunctional breathing is a respiratory disorder characterized by irregular breathing patterns, occurring either in the absence of concurrent diseases or secondary to cardiopulmonary conditions. Dysfunctional breathing leads to symptoms such as hyperventilation, dyspnea, increased accessory muscle activity, paradoxical breathing, postural disorders, sleep disturbances, fatigue, and difficulty concentrating. Reports demonstrate that pulmonary rehabilitation reduces symptoms of dysfunctional breathing.

In studies on asthma patients, pulmonary rehabilitation has been reported to have a positive effect on dysfunctional breathing and to improve quality of life as well as anxiety and depression levels. In studies on COPD patients, reductions in dyspnea levels and respiratory symptoms, along with increases in physical activity levels, have been observed. A case study reported that a pulmonary rehabilitation program including breathing and posture exercises improved dysfunctional breathing symptoms, increased breath-holding time, reduced pain and depression findings, and enhanced attention and concentration levels. A review of the literature indicates that studies on dysfunctional breathing are quite limited. Furthermore, no studies have been identified examining dysfunctional breathing in ACOS patients. Therefore, investigating the effects of video game-based breathing exercises on dysfunctional breathing in ACOS patients represents an original contribution.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Aged between 40 and 80 years
  • •Diagnosed with Asthma-COPD Overlap Syndrome (ACOS)
  • •Nijmegen Questionnaire score ≥ 23
  • •No severe asthma
  • •No severe COPD
  • •In a stable condition (no acute exacerbation in the last 4 weeks)
  • •To have the cognitive level suitable to adapt to video games

排除标准

  • •Contraindicated for pulmonary rehabilitation
  • •Diagnosed with cancer
  • •Having severe cardiovascular disease
  • •History of thoracic surgery
  • •Presence of acute infectious disease
  • •Cognitive impairment
  • •Presence of vertigo, epilepsy, or visual impairment

研究组 & 干预措施

Group 1: The group receiving video game-based breathing exercises

Experimental

Participants in the study group will undergo the "Breathing Games" exercise program twice a week for 8 weeks, with each session lasting approximately 50 minutes.

干预措施: Video game-based breathing exercises (Other)

Group 2: Control group

Experimental

Participants in the control group will receive a 30-45 minute patient education session after the assessment.

干预措施: Control group (Other)

结局指标

主要结局

Capnography

时间窗: All assessments will be performed on the participants at the first session and repeated after 8 weeks.

It will be used to evaluate whether ventilation is adequate and if the breathing pattern is appropriate. It is a monitoring device that continuously records the concentration of CO₂ in the exhaled gases during respiration graphically (in mmHg), providing information about the patient's respiratory rate per minute and the amount of CO₂ exhaled in each breath. It measures the partial pressure of CO₂ in the exhaled air, referred to as end-tidal CO₂ (ETCO₂), which is a reliable and time-sensitive clinical measurement of respiratory function. ETCO₂ shows good concurrent validity when compared directly with blood measurements. A value of 35 mmHg or below is commonly used as a cutoff point to define hypocapnia.

Hi-Lo Test

时间窗: All assessments will be performed on the participants at the first session and repeated after 8 weeks.

This is a clinical assessment used to evaluate the breathing pattern, specifically to determine whether thoracic (chest) or abdominal (diaphragm) movement is more dominant. The patient is seated comfortably, and the clinician stands or kneels slightly to the side in front of the patient. The clinician places one hand on the patient's sternum (breastbone) and the other hand on the upper abdomen (just below the rib cage). This allows the clinician to feel the movements of both the chest and abdominal areas during inhalation. The clinician observes and senses which area moves more with each breath, indicating whether the patient primarily uses chest or abdominal muscles for breathing. Five breathing cycles are assessed.

Manual Assessment of Respiratory Movements (MARM)

时间窗: All assessments will be performed on the participants at the first session and repeated after 8 weeks.

This method is used to evaluate and measure breathing patterns, particularly the distribution of respiratory movements between the upper and lower parts of the rib cage and the abdomen under various conditions. The 4th and 5th fingers of both hands are placed on the lower ribs, and the vertical and horizontal mobility of the fingers is assessed while the patient breathes in and out. If there is more vertical and upper rib cage movement, the upper line will be farther from the horizontal and closer to the apex. If there is more lateral and lower rib cage/abdominal movement, the lower line will be farther from the horizontal and closer to the base.

Posture Assessment - Posture Screen Application

时间窗: All assessments will be performed on the participants at the first session and repeated after 8 weeks.

Posture examination will be performed using the PostureScreen® Mobile application through a photographic method. This application essentially digitizes a valid posture assessment technique, namely the photographic method using a vertical plumb line or lead wire method. This examination is simple, quick, easily repeatable, and does not require in-depth knowledge of posturology. For cervical measurements, forward head tilt, cervical lordosis angle, and lateral deviations of the neck will be evaluated. For thoracic measurements, thoracic kyphosis angle, shoulder height difference, thoracic scoliosis, and scapular position will be assessed.

Nijmegen Questionnaire

时间窗: All assessments will be performed on the participants at the first session and repeated after 8 weeks.

The Nijmegen Questionnaire is a valid and reliable self-report tool used for the diagnosis of dysfunctional breathing syndrome. Dysfunctional breathing is a disorder characterized by irregular or abnormal breathing patterns, often confused with conditions such as asthma or anxiety. The questionnaire was developed to assess the frequency of respiratory-related symptoms and consists of 16 items in total. These items include clinically relevant symptoms such as shortness of breath, chest pain, dizziness, and tingling sensations. Each item is scored on a scale from 0 (never) to 4 (very often), and the total score provides information about the severity of dysfunctional breathing.

次要结局

  • FEV₁ assesment(All assessments will be performed on the participants at the first session and repeated after 8 weeks.)
  • Breath-Holding Time Test(All assessments will be performed on the participants at the first session and repeated after 8 weeks.)
  • 30-Second Sit-to-Stand Test(All assessments will be performed on the participants at the first session and repeated after 8 weeks.)
  • 6-Minute Walk Test (6MWT)(All assessments will be performed on the participants at the first session and repeated after 8 weeks.)
  • St. George's Respiratory Questionnaire (SGRQ)(All assessments will be performed on the participants at the first session and repeated after 8 weeks.)
  • Fatigue Severity Scale (FSS)(All assessments will be performed on the participants at the first session and repeated after 8 weeks.)
  • Pittsburgh Sleep Quality Index (PSQI)(All assessments will be performed on the participants at the first session and repeated after 8 weeks.)
  • Beck Anxiety Inventory (BAI)(All assessments will be performed on the participants at the first session and repeated after 8 weeks.)
  • Beck Depression Inventory (BDI)(All assessments will be performed on the participants at the first session and repeated after 8 weeks.)
  • FEV₁/FVC ratio evaluation(All evaluations will be made to the participants in the first session and will be repeated after 8 weeks.)
  • PEF Assessment(All evaluations will be made to the participants in the first session and will be repeated after 8 weeks.)
  • FEF25-75 assessment(All evaluations will be made to the participants in the first session and will be repeated after 8 weeks.)
  • FVC assessment(All assessments will be performed on the participants at the first session and repeated after 8 weeks.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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