NCT07185178

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Aug 2025Jun 2026

First Submitted

Initial submission to the registry

August 3, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

August 4, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 22, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2026

Expected
Last Updated

September 22, 2025

Status Verified

June 1, 2025

Enrollment Period

Same day

First QC Date

August 3, 2025

Last Update Submit

September 17, 2025

Conditions

Keywords

asthma-copd overlap syndromepulmonary rehabilitationdysfunctional breathingvideo games

Outcome Measures

Primary Outcomes (5)

  • Capnography

    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.

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

  • Hi-Lo Test

    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.

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

  • Manual Assessment of Respiratory Movements (MARM)

    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.

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

  • Posture Assessment - Posture Screen Application

    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.

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

  • Nijmegen Questionnaire

    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.

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

Secondary Outcomes (13)

  • 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.

  • +8 more secondary outcomes

Study Arms (2)

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.

Other: Video game-based breathing exercises

Group 2: Control group

EXPERIMENTAL

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

Other: Control group

Interventions

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 program will consist of a warm-up phase lasting approximately 10 minutes, including breathing control, stretching exercises, and rest; 25-30 minutes of five breathing games combined with posture exercises; followed by a cool-down phase of about 10 minutes with breathing control, stretching exercises, and rest.Additionally, participants will be provided with a home exercise program to be performed twice daily for 30 minutes, three days a week, over 8 weeks.

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

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 lifestyle modifications (e.g., smoking cessation, physical activity recommendations) To maintain and improve physical activity levels, patients will be advised to engage in walking activities for 30 minutes, twice a week After covering these topics, participants will be given brochures containing this information. Additionally, follow-up will be conducted by phone every two weeks. All assessments will be repeated at the end of the 8-week period.

Group 2: Control group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University Training and Research Hospital

Kocaeli, Izmit, 41000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome

Interventions

Control Groups

Condition Hierarchy (Ancestors)

AsthmaBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesPulmonary Disease, Chronic ObstructiveRespiratory HypersensitivityHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • HÜSNA GÜZEL, PT,PhD (c)

    Istinye University

    PRINCIPAL INVESTIGATOR
  • NURGÜL DÜRÜSTKAN ELBASI, asst. prof.

    Istinye University

    STUDY DIRECTOR
  • TUGBA ÖNYILMAZ, asst. prof.

    Kocaeli University

    STUDY CHAIR
  • Haşim Boyacı, Prof. Dr

    Kocaeli University

    STUDY CHAIR

Central Study Contacts

HÜSNA GÜZEL, PT,PhD (c)

CONTACT

NURGÜL DÜRÜSTKAN ELBASI, asst. prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2025

First Posted

September 22, 2025

Study Start

August 4, 2025

Primary Completion

August 4, 2025

Study Completion (Estimated)

June 10, 2026

Last Updated

September 22, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

For reasons of participant confidentiality and ethical considerations, sharing of individual participant data (IPD) is not planned for this study.

Locations