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OpenTrials
Completed

NCT Number: NCT03375684

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

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.

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Key information

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation

Istanbul, Eyup, 34060, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional Chest Physiotherapy

Other

Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), oscillatory PEP (Flutter), postural drainage and coughing tecniques.

Inspiratory Muscle Training

Other

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

Primary outcomes

  1. Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks

    Time frame: Eight weeks

  2. Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks

    Time frame: Eight weeks

  3. Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks

    Time frame: Eight weeks

  4. Change from baseline Forced Vital Capacity (FVC) at 8 weeks

    Time frame: Eight weeks

  5. Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks

    Time frame: Eight weeks

  6. Change from baseline Peak Expiratory Flow (PEF) at 8 weeks

    Time frame: Eight weeks

  7. Change from baseline maximum inspiratory pressure at 8 weeks

    Time frame: Eight weeks

  8. Change from baseline maximum expiratory pressure at 8 weeks

    Time frame: Eight weeks

  9. Change from baseline distance covered in six-minute walk test at 8 weeks

    Time frame: Eight weeks

Secondary outcomes

  1. Change from baseline m. quadriceps strength at 8 weeks

    Time frame: Eight weeks

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 18, 2017
Registry last updated
May 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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