Functional Inspiratory Training in Bronchiectasis

Official title

Effects of Functional Inspiratory Muscle Training on Pulmonary Function, Muscle Thickness, and Core Performance in Patients With Bronchiectasis

Overview

Bronchiectasis is a chronic respiratory disease clinically characterized by recurrent pulmonary exacerbations, chronic cough, and sputum production, and is associated with an increase in the airway-artery ratio and permanent airway dilatation. It is recognized as the third most common chronic respiratory disease after chronic obstructive pulmonary disease (COPD) and asthma. In the International Classification of Diseases and Related Health Problems (ICD-10), it has its own diagnostic code (J47.9). In bronchiectasis, mucociliary clearance is impaired due to bronchial dilatation, and the insufficient clearance of bacteria and mucus from the respiratory tract leads to persistent infection, inflammation, and further airway damage. Progressive airway damage results in impaired lung function, worsening of symptoms, and, ultimately, respiratory failure and death. It can represent the final pathway of various infectious, allergic, inflammatory, genetic, and degenerative disorders, making it one of the most complex and heterogeneous syndromes. Some patients present with daily symptoms, while others remain asymptomatic except during exacerbations. The most common symptom is chronic cough caused by purulent or mucopurulent sputum. Other symptoms include dyspnea, pleuritic chest pain, wheezing, fatigue, and weight loss. Fever, however, is not a common finding and differs from pneumonia. The most frequently used classification system categorizes bronchiectasis into varicose, cylindrical, and saccular (cystic) types. In the most severe form, the saccular type, the bronchi lose their structural integrity completely, forming cystic structures filled with secretions. The mildest form is cylindrical, in which the bronchi have thick, straight walls. In the varicose type, localized narrowings are observed. Diagnosis is made following history and physical examination, with high-resolution computed tomography (HRCT) being the most sensitive and specific method, along with sputum culture and chest radiography. The goals of bronchiectasis treatment are to manage symptoms, prevent complications, and improve quality of life. Both pharmacological and patient-managed interventions are commonly applied. Pharmacological treatments include antibiotics, bronchodilators, and corticosteroids, which are generally administered via inhalation. Patient-managed interventions require active participation and behavioral modification. Within published guidelines, airway clearance techniques are widely described under pulmonary rehabilitation (PR), but there is no consensus regarding PR itself. For individuals with reduced exercise tolerance, participation in PR and engagement in physical activity are recommended. However, research has shown that referral rates to PR are often low, and exercise and physical activity are not consistently prescribed. Within PR, techniques such as the active cycle of breathing techniques (ACBT), postural drainage, thoracic expansion exercises, and various airway clearance methods are applied, with inspiratory muscle training (IMT) forming an important component. Functional inspiratory muscle training (FIMT) is an IMT program developed by considering not only the ventilatory roles of the respiratory muscles but also their non-respiratory functions. FIMT integrates inspiratory muscle training with core stabilization and postural control exercises. The rhythmic co-contractions of the muscles in the core region support trunk stability and provide the basis for movement. In the first stage of the program, participants receive IMT, and subsequently, core stabilization training and dynamic trunk activation exercises are incorporated into the intervention. A review of the literature reveals that no studies have investigated the effectiveness of FIMT in adults with bronchiectasis. In our study, we aim to evaluate the effects of FIMT, applied in addition to home-based chest physiotherapy, on pulmonary function, diaphragm thickness, balance, core stability, functional capacity, physical activity, posture, and quality of life in adults with bronchiectasis. Furthermore, we aim to compare these outcomes with those of IMT applied alongside home-based chest physiotherapy. We believe that this approach will contribute to the development of treatment strategies in clinical practice and help address existing gaps in the literature.

Interventions

• Other Functional Inspiratory Muscle Training (FIMT)
  Participants will begin with Inspiratory Muscle Training (IMT) at 50% of maximal inspiratory pressure (MIP) for 4 weeks. Training will be performed once a week face-to-face, while adherence will be monitored on other days via WhatsApp. During each face-to-face session, MIP will be reassessed and training loads adjusted. Participants will perform 30 dynamic inspiratory efforts twice daily. In the following 4 weeks, Functional Inspiratory Muscle Training (FIMT) will be applied: once face-to-face,
• Other Inspiratory Muscle Training (IMT)
  Participants will perform IMT daily for 8 weeks. Training will be conducted once a week face-to-face, while on other days adherence will be monitored via WhatsApp. The group will complete 30 dynamic inspiratory efforts twice daily. The POWERbreathe Classic Light Resistance device (PowerBreathe, IMT Technologies Ltd, Birmingham, UK) will be used to strengthen the diaphragm and chest wall muscles by breathing against a set pressure load. Training intensity will be set at 50% of maximal inspiratory

Primary outcome measures

• Forced Expiratory Volume in 1 Second (FEV1) [Time frame: At baseline (before the intervention) and at the end of the 8th week of intervention]
• Forced Vital Capacity (FVC) [Time frame: At baseline (before the intervention) and at the end of the 8th week of intervention]
• FEV1/FVC Ratio [Time frame: At baseline (before the intervention) and at the end of the 8th week of intervention]
• Peak Expiratory Flow (PEF) [Time frame: At baseline (before the intervention) and at the end of the 8th week of intervention]
• Forced Expiratory Flow (FEF25-75%) [Time frame: At baseline (before the intervention) and at the end of the 8th week of intervention.]
• Maximal Inspiratory Pressure (MIP) [Time frame: Baseline and Week 8(Post-Intervention)]
• Maximal Expiratory Pressure (MEP) [Time frame: Baseline and Week 8 (Post-Intervention)]
• Biceps Brachii Muscle Strength [Time frame: At baseline and at the end of the 8th week of intervention.]
• Quadriceps Femoris Muscle Strength [Time frame: At baseline and at the end of the 8th week of intervention.]
• Handgrip Strength [Time frame: At baseline and at the end of the 8th week of intervention.]

Secondary outcome measures (6)

• Physical Activity (Accelerometer Assessment) [Time frame: At baseline and at the end of the 8th week of intervention.]
• Posture Assessment [Time frame: At baseline and at the end of the 8th week of intervention.]
• Quality of Life (Leicester Cough Questionnaire - LCQ) [Time frame: At baseline and at the end of the 8th week of intervention.]
• Patient Satisfaction (Telemedicine Satisfaction Questionnaire - TSQ) [Time frame: At the end of the 8th week of intervention.]
• Treatment Adherence (Exercise Diary) [Time frame: During the 8-week intervention.]
• Perceived Health Change (Global Rating of Change - GROC) [Time frame: At the end of the 8th week of intervention.]

Eligibility criteria

Inclusion criteria

• Age between 18 and 30 years
• Diagnosed with bronchiectasis
• Clinically stable
• Able to cooperate
• Able to walk independently
• Volunteering to participate in the study

Exclusion criteria

• History of acute exacerbation and/or hospitalization within the past 4 weeks
• Change in medical treatment within the past month
• Known diagnosed conditions affecting balance (visual, auditory, vestibular, or musculoskeletal disorders)
• Participation in a supervised physiotherapy rehabilitation program within the past 6 months
• History of lung or liver transplantation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Istinye University, Istanbul, — Istanbul

Identifiers

NCT: NCT07188675 · ISU-2025-005

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗