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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03375684
• Other study ID #: bvumzeren01
• Status: Completed
• Phase: N/A
• Start date: January 2, 2018
• Est. completion date: May 21, 2018

Study information

• Verified date: May 2018
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 21, 2018
• Est. primary completion date: May 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Respiratory Aspiration

Intervention

Other:
• Conventional chest physiotherapy
Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), oscillatory PEP (Flutter), postural drainage and coughing tecniques.
• Inspiratory muscle training
Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation	Istanbul	Eyup

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks		Eight weeks
Primary	Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks		Eight weeks
Primary	Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks		Eight weeks
Primary	Change from baseline Forced Vital Capacity (FVC) at 8 weeks		Eight weeks
Primary	Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks		Eight weeks
Primary	Change from baseline Peak Expiratory Flow (PEF) at 8 weeks		Eight weeks
Primary	Change from baseline maximum inspiratory pressure at 8 weeks		Eight weeks
Primary	Change from baseline maximum expiratory pressure at 8 weeks		Eight weeks
Primary	Change from baseline distance covered in six-minute walk test at 8 weeks		Eight weeks
Secondary	Change from baseline m. quadriceps strength at 8 weeks		Eight weeks