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Clinical Trials/NCT03790410
NCT03790410
Completed
Not Applicable

The Effect of Inspiratory Muscle Training on Postural Control in Chronic Obstructive Pulmonary Disease

Szeged University1 site in 1 country40 target enrollmentJuly 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD Postural Control IMT
Sponsor
Szeged University
Enrollment
40
Locations
1
Primary Endpoint
Maximal Inspiratory Pressure
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Deficits in postural control are increasingly recognized among the important secondary impairments in patients with chronic obstructive pulmonary disease (COPD). There are conflicting results regarding the effect of inspiratory muscle training in improvement of inspiratory muscle strength, endurance, and dyspnea in stable COPD patients. The main inspiratory muscle, the diaphragm has also a stabilizing function of the trunk. The aim of this study to enhance postural control of COPD patients with improving the stability of the trunk by using inspiratory muscle training.

Detailed Description

The study is a randomized controlled trial in patients with stable COPD. The participants are divided into two groups. Patients in the inspiratory muscle training (IMT) group take part in a complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings completed by inspiratory muscle training. The members of the IMT group use the POWERbreathe Medic device. The control group perform the complex pulmonary rehabilitation program without IMT. The program is divided into 3 weeks inpatient period and 3 weeks home period. Before, between and after the 3 weeks period all subjects are measured. 60 patients are planned to take part in the investigation. The inspiratory muscle strength is measured by POWERbreathe K1 device. Balance is assessed by functional balance tests: Timed Up and Go Test, Four Square Step Test, Modified Functional Reach Test, Modified Lateral Reach Test, Stand Up Test. Body Sway is measured by HR Mat VersaTek System. The diameter of the diaphragm muscle is assessed by B-mode ultrasound examination using Zonare Z. One Ultrasound System. Arterial stiffness parameters measured by Arteriograph.

Registry
clinicaltrials.gov
Start Date
July 1, 2017
End Date
February 28, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Szeged University
Responsible Party
Principal Investigator
Principal Investigator

Levente Szilagyi

University Lecturer

Szeged University

Eligibility Criteria

Inclusion Criteria

  • Stable COPD
  • Do not take part in other treatment
  • Be able to learn the usage of inspiratory muscle trainer

Exclusion Criteria

  • Acute exacerbation
  • Balance problems with neurological cause
  • The patient unable to cooperate
  • Participation in pulmonary rehabilitation 3 months before the study
  • IMT use in the 3 months before the study

Outcomes

Primary Outcomes

Maximal Inspiratory Pressure

Time Frame: 6 weeks

The inspiratory pressure generated against a completely occluded airway; used to evaluate inspiratory respiratory muscle strength and readiness for weaning from A maximum inspiratory pressure is measured in H2Ocm. MIP is measured with POWERbreathe K1

Timed Up and Go Test

Time Frame: 6 weeks

Timed Up and Go: It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.

Four Square Step Test

Time Frame: 6 weeks

Four Square Step Test: The subject is required to sequentially step over four canes set-up in a cross configuration on the ground. The aim is to step as fast as possible into each square with both feet.

Modified Functional Reach Test

Time Frame: 6 weeks

Modified Functional Reach Test: The MFRT assesses a patient's stability by measuring the maximum distance an individual can reach forward while sitting in a fixed position.

Modified Lateral Reach Test

Time Frame: 6 weeks

Modified Lateral Reach Test: The MLRT assesses a patient's stability by measuring the maximum distance an individual can reach side direction while sitting in a fixed position.

Stand Up Test

Time Frame: 6 weeks

Stand Up Test: Individual stand up from tailor sit from the floor as fast as possible.

Secondary Outcomes

  • Sway analysis: COF distance (cm)(6 weeks)
  • Sway analysis: COF variability (cm)(6 weeks)
  • Sway analysis: COF area (cm2)(6 weeks)
  • Sway analysis: COF A-P excursion (cm)(6 weeks)
  • Thickness of the diaphragm muscle's belly(6 weeks)
  • Sway analysis: COF L-R excursion (cm)(6 weeks)
  • Pulse wave velocity(6 weeks)
  • Vibration Sense Testing(6 weeks)
  • Augmentation index(6 weeks)

Study Sites (1)

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