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

NCT03375684 | Completed

• 1 other identifier: bvumzeren01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Inspiratory Muscle Training; Chest Physiotherapy; Balance; Postural Stability; Pulmonary Function Test; 6-Minute Walk Test

Outcome Measures

Primary Outcomes (9)

• 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

• 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 maximum inspiratory pressure at 8 weeks

  Eight weeks

• Change from baseline maximum expiratory pressure at 8 weeks

  Eight weeks

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

  Eight weeks

Secondary Outcomes (1)

• Change from baseline m. quadriceps strength at 8 weeks

  Eight weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Training Group

EXPERIMENTAL

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: Conventional chest physiotherapy; Other: Inspiratory muscle training

Interventions

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.

Control Group; Training Group

Inspiratory muscle training OTHER

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

Training Group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Cystic fibrosis diagnosis
• Stable clinical condition (no exacerbation in last 4 weeks)

You may not qualify if:

• Documented diagnosis of vestibular, neurological or orthopedic disorders which may affect balance and mobility
• Subjects previously involved in exercise training or physiotherapy programs

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation

Istanbul, Eyup, 34060, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 30827470 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, MSc, PT

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 18, 2017
• Study Start: January 2, 2018
• Primary Completion: May 2, 2018
• Study Completion: May 21, 2018
• Last Updated: May 23, 2018

Record last verified: 2018-05

Locations

TU (1)