Clinical trial NCT03375684: Effects of Inspiratory Muscle Training on Postural Stability, Balance, Pulmonary Function and Functional Capacity in Children With Cystic Fibrosis
Official title: Effects of Inspiratory Muscle Training on Postural Stability, Balance, Pulmonary Function and Functional Capacity in Children With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Inspiratory Muscle Training
Chest Physiotherapy
Balance
Postural Stability
Pulmonary Function Test
6-Minute Walk Test
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 32
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline Forced Vital Capacity (FVC) at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline maximum inspiratory pressure at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline maximum expiratory pressure at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline distance covered in six-minute walk test at 8 weeks
timeFrame: Eight weeks
Secondary outcomes:
measure: Change from baseline m. quadriceps strength at 8 weeks
timeFrame: Eight weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation
state: Eyup
Study officials:
References:
citation: Zeren M, Cakir E, Gurses HN. Effects of inspiratory muscle training on postural stability, pulmonary function and functional capacity in children with cystic fibrosis: A randomised controlled trial. Respir Med. 2019 Mar;148:24-30. doi: 10.1016/j.rmed.2019.01.013. Epub 2019 Jan 28.