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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: May 2, 2018

Interventions

  • 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.
  • Other: Inspiratory muscle training
    • Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure.

Arms, Groups and Cohorts

  • Active Comparator: Control Group
    • 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.
  • Experimental: Training Group
    • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Change from baseline m. quadriceps strength at 8 weeks
    • Time Frame: Eight weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bezmialem Vakif University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Melih Zeren, Lecturer, MSc, PT – Bezmialem Vakif University

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