search
Back to results

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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional chest physiotherapy
Inspiratory muscle training
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, Inspiratory Muscle Training, Chest Physiotherapy, Balance, Postural Stability, Pulmonary Function Test, 6-Minute Walk Test

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Training Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
Change from baseline maximum inspiratory pressure at 8 weeks
Change from baseline maximum expiratory pressure at 8 weeks
Change from baseline distance covered in six-minute walk test at 8 weeks

Secondary Outcome Measures

Change from baseline m. quadriceps strength at 8 weeks

Full Information

First Posted
December 6, 2017
Last Updated
May 22, 2018
Sponsor
Bezmialem Vakif University
search

1. Study Identification

Unique Protocol Identification Number
NCT03375684
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
May 2, 2018 (Actual)
Study Completion Date
May 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic Fibrosis, Inspiratory Muscle Training, Chest Physiotherapy, Balance, Postural Stability, Pulmonary Function Test, 6-Minute Walk Test

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Training Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional chest physiotherapy
Intervention Description
Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), oscillatory PEP (Flutter), postural drainage and coughing tecniques.
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training
Intervention Description
Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure.
Primary Outcome Measure Information:
Title
Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline maximum inspiratory pressure at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline maximum expiratory pressure at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline distance covered in six-minute walk test at 8 weeks
Time Frame
Eight weeks
Secondary Outcome Measure Information:
Title
Change from baseline m. quadriceps strength at 8 weeks
Time Frame
Eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation
City
Istanbul
State/Province
Eyup
ZIP/Postal Code
34060
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30827470
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs