Effects of Inspiratory Muscle Training on Postural Stability, Balance, Pulmonary Function and Functional Capacity in Children With Cystic Fibrosis

Study Overview
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Brief Summary
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It is extensively reported in the literature that patients with chronic obstructive lung disease may have impairments in balance and postural control which further increase the disease burden. Mechanisms related to these impairments include, but are not limited to increased work of breathing, diaphragm weakness, peripheral muscle weakness and systemic inflammation. Since the similar symptoms are reported for the children with cystic fibrosis, it is hypothesized that balance and postural control may also be compromised in these patients. Inspiratory muscle training (IMT) is shown to improve diaphragm strength and pulmonary function. Considering the relation between diaphragm which is one of the core muscles, and balance, IMT may also have an impact on postural control and balance alongside the standard clinical parameters such as respiratory muscle strength, pulmonary function and functional capacity in these patients. Thus, the aim of this study was to investigate the effects of inspiratory muscle training and conventional chest physiotherapy on postural stability, balance, pulmonary function and functional capacity in children with cystic fibrosis.

Official Title
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Effects of Inspiratory Muscle Training on Postural Stability, Balance, Pulmonary Function and Functional Capacity in Children With Cystic Fibrosis

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Other: Conventional chest physiotherapy
* Other: Inspiratory muscle training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cystic fibrosis diagnosis Stable clinical condition (no exacerbation in last 4 weeks) Exclusion Criteria: Documented diagnosis of vestibular, neurological or orthopedic disorders which may affect balance and mobility Subjects previously involved in exercise training or physiotherapy programs

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Patients in this group will receive conventional chest physiotherapy, two times a day, 7 days a week for 8 weeks. One exercise session will be supervised in a clinic per week, other sessions will be performed at home. | Other: Conventional chest physiotherapy<br>* Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), oscillatory PEP (Flutter), postural drainage and coughing tecniques.<br>|
| Experimental: Training Group<br>In addition to conventional chest physiotherapy programme, patients in this group will also receive inspiratory muscle training for 15 minutes, twice a day, 7 days a week for 8 weeks. One exercise session will be supervised in a clinic per week, other sessions will be performed at home. | Other: Conventional chest physiotherapy<br>* Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), oscillatory PEP (Flutter), postural drainage and coughing tecniques.<br>Other: Inspiratory muscle training<br>* Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks |  | Eight weeks | 
| Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks |  | Eight weeks | 
| Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks |  | Eight weeks | 
| Change from baseline Forced Vital Capacity (FVC) at 8 weeks |  | Eight weeks | 
| Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks |  | Eight weeks | 
| Change from baseline Peak Expiratory Flow (PEF) at 8 weeks |  | Eight weeks | 
| Change from baseline maximum inspiratory pressure at 8 weeks |  | Eight weeks | 
| Change from baseline maximum expiratory pressure at 8 weeks |  | Eight weeks | 
| Change from baseline distance covered in six-minute walk test at 8 weeks |  | Eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline m. quadriceps strength at 8 weeks |  | Eight weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Balance, Cystic Fibrosis, Inspiratory Muscle Training, Chest Physiotherapy, Postural Stability, Pulmonary Function Test, 6-Minute Walk Test