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Идёт набор NCT07185178

Effect of Video Game-Based Breathing Exercises on Respiratory Dysfunction in ACOS

Без фазы С лечением Asthma-COPD Overlap Syndrome Pulmonary Rehabilitation Video Games

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Video game-based breathing exercises, Control group.
Кому может быть актуально
Состояния в реестре: Asthma-COPD Overlap Syndrome, Pulmonary Rehabilitation, Video Games. Базовые параметры: 40 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

The objective of the present research is to investigate the effects of video game-based breathing exercises on dysfunctional breathing in patients with ACOS.

Вмешательства

  • Другое Video game-based breathing exercises
    Twenty individuals will be enrolled in the video game-based breathing exercise program. 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. This video game-based breathing exercise program includes warm-up, cool-down, and five breathing games designed for the target patients.From the second week onward, posture exercises combined with the breathing games will be added.Thus, the exercise
  • Другое Control group
    Participants in the control group will receive a 30-45 minute patient education session after the assessment. The content of the education will include: Providing general information about Asthma-COPD Overlap Syndrome (ACOS) Teaching dyspnea-relieving positions Instruction in diaphragmatic breathing techniques Teaching secretion clearance methods (Active Cycle of Breathing Techniques - ACBT) Educating on energy conservation strategies Providing information on correct posture Counseling on lifes

Первичные конечные точки

  • Capnography [Срок оценки: All assessments will be performed on the participants at the first session and repeated after 8 weeks.]
  • Hi-Lo Test [Срок оценки: All assessments will be performed on the participants at the first session and repeated after 8 weeks.]
  • Manual Assessment of Respiratory Movements (MARM) [Срок оценки: All assessments will be performed on the participants at the first session and repeated after 8 weeks.]
  • Posture Assessment - Posture Screen Application [Срок оценки: All assessments will be performed on the participants at the first session and repeated after 8 weeks.]
  • Nijmegen Questionnaire [Срок оценки: All assessments will be performed on the participants at the first session and repeated after 8 weeks.]
Вторичные конечные точки (12)
  • FEV₁ assesment [Срок оценки: All assessments will be performed on the participants at the first session and repeated after 8 weeks.]
  • Breath-Holding Time Test [Срок оценки: All assessments will be performed on the participants at the first session and repeated after 8 weeks.]
  • 30-Second Sit-to-Stand Test [Срок оценки: All assessments will be performed on the participants at the first session and repeated after 8 weeks.]
  • 6-Minute Walk Test (6MWT) [Срок оценки: All assessments will be performed on the participants at the first session and repeated after 8 weeks.]
  • St. George's Respiratory Questionnaire (SGRQ) [Срок оценки: All assessments will be performed on the participants at the first session and repeated after 8 weeks.]
  • Fatigue Severity Scale (FSS) [Срок оценки: All assessments will be performed on the participants at the first session and repeated after 8 weeks.]
  • Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: All assessments will be performed on the participants at the first session and repeated after 8 weeks.]
  • Beck Anxiety Inventory (BAI) [Срок оценки: All assessments will be performed on the participants at the first session and repeated after 8 weeks.]
  • Beck Depression Inventory (BDI) [Срок оценки: All assessments will be performed on the participants at the first session and repeated after 8 weeks.]
  • FEV₁/FVC ratio evaluation [Срок оценки: All evaluations will be made to the participants in the first session and will be repeated after 8 weeks.]
  • PEF Assessment [Срок оценки: All evaluations will be made to the participants in the first session and will be repeated after 8 weeks.]
  • FEF25-75 assessment [Срок оценки: All evaluations will be made to the participants in the first session and will be repeated after 8 weeks.]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Kocaeli University Training and Research Hospital — Kocaeli

Идентификаторы

NCT: NCT07185178 · hg_tez

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗