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

NCT ID: NCT03375684

Last Updated: 2018-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-02
• Study Completion Date: 2018-05-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Conventional chest physiotherapy

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Conventional chest physiotherapy

Intervention Type: 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

Intervention Type: OTHER

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

Interventions

Conventional chest physiotherapy

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

Intervention Type: OTHER

Inspiratory muscle training

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Melih Zeren

Lecturer, MSc, PT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation

Istanbul, Eyup, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 30827470 (View on PubMed)

Other Identifiers

bvumzeren01

Identifier Type: -

Identifier Source: org_study_id