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

NCT ID: NCT03790410

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2020-02-28

Brief Summary

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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

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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.

Conditions

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COPD Postural Control IMT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control group-Complex pulmonary rehab.

Complex pulmonary rehabilitation:

The complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings.

Group Type ACTIVE_COMPARATOR

Complex pulmonary rehabilitation

Intervention Type OTHER

Complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings.

Inspiratory muscle training group

Complex pulmonary rehabilitation:

The complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings.

Inspiratory muscle training

The training program contains strengthening exercises on the diaphragm muscle.

Group Type ACTIVE_COMPARATOR

Complex pulmonary rehabilitation

Intervention Type OTHER

Complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings.

Inspiratory muscle training

Intervention Type OTHER

The training program contains strengthening exercises on the diaphragm muscle.

Interventions

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Complex pulmonary rehabilitation

Complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings.

Intervention Type OTHER

Inspiratory muscle training

The training program contains strengthening exercises on the diaphragm muscle.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Szeged University

OTHER

Sponsor Role lead

Responsible Party

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Levente Szilagyi

University Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Szeged

Szeged, Csongrád megye, Hungary

Site Status

Countries

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Hungary

Other Identifiers

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COPD IMT PC

Identifier Type: -

Identifier Source: org_study_id