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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Other: Inspiratory muscle training; Other: Conventional chest physiotherapy

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Eyup
    • Istanbul, Eyup, Turkey, 34060
      • Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	Other: Inspiratory muscle training; Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 distance covered in six-minute walk test 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 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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): May 2, 2018
• Study Completion (Actual): May 21, 2018

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): May 23, 2018
• Last Update Submitted That Met QC Criteria: May 22, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Balance; Cystic Fibrosis; Postural Stability; Inspiratory Muscle Training; Chest Physiotherapy; Pulmonary Function Test; 6-Minute Walk Test
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Respiratory Aspiration; Cystic Fibrosis
• Other Study ID Numbers: bvumzeren01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No