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

Not Applicable
Completed
Conditions
COPD Postural Control IMT
Interventions
Other: Complex pulmonary rehabilitation
Other: Inspiratory muscle training
Registration Number
NCT03790410
Lead Sponsor
Szeged University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control group-Complex pulmonary rehab.Complex pulmonary rehabilitationComplex pulmonary rehabilitation: The complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings.
Inspiratory muscle training groupComplex pulmonary rehabilitationComplex 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.
Inspiratory muscle training groupInspiratory muscle trainingComplex 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.
Primary Outcome Measures
NameTimeMethod
Maximal Inspiratory Pressure6 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 Test6 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 Test6 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 Test6 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 Test6 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 Test6 weeks

Stand Up Test:

Individual stand up from tailor sit from the floor as fast as possible.

Secondary Outcome Measures
NameTimeMethod
Sway analysis: COF distance (cm)6 weeks

Sway is the oscillating movement of the body, while posture is the relative alignment and orientation of the segments of the body. Sway analysis is a systematic assessment of the readiness and stability of the human body to achieve and maintain equilibrium. Area and direction of sway, elliptical pattern of sway, distance and direction traveled by Center of Force (CoF) is measured with HR Mat VersaTek System.

Sway analysis: COF variability (cm)6 weeks

Sway is the oscillating movement of the body, while posture is the relative alignment and orientation of the segments of the body. Sway analysis is a systematic assessment of the readiness and stability of the human body to achieve and maintain equilibrium. Area and direction of sway, elliptical pattern of sway, distance and direction traveled by Center of Force (CoF) is measured with HR Mat VersaTek System.

Sway analysis: COF area (cm2)6 weeks

Sway is the oscillating movement of the body, while posture is the relative alignment and orientation of the segments of the body. Sway analysis is a systematic assessment of the readiness and stability of the human body to achieve and maintain equilibrium. Area and direction of sway, elliptical pattern of sway, distance and direction traveled by Center of Force (CoF) is measured with HR Mat VersaTek System.

Sway analysis: COF A-P excursion (cm)6 weeks

Sway is the oscillating movement of the body, while posture is the relative alignment and orientation of the segments of the body. Sway analysis is a systematic assessment of the readiness and stability of the human body to achieve and maintain equilibrium. Area and direction of sway, elliptical pattern of sway, distance and direction traveled by Center of Force (CoF) is measured with HR Mat VersaTek System.

Thickness of the diaphragm muscle's belly6 weeks

The diameter of the diaphragm muscle is assessed by B-mode ultrasound examination using Zonare Z. One Ultrasound System.

Sway analysis: COF L-R excursion (cm)6 weeks

Sway is the oscillating movement of the body, while posture is the relative alignment and orientation of the segments of the body. Sway analysis is a systematic assessment of the readiness and stability of the human body to achieve and maintain equilibrium. Area and direction of sway, elliptical pattern of sway, distance and direction traveled by Center of Force (CoF) is measured with HR Mat VersaTek System.

Pulse wave velocity6 weeks

Pulse wave velocity is measured with Arteriograph.

Vibration Sense Testing6 weeks

Tuning fork is used to evaluate the deep sensation.

Augmentation index6 weeks

Augmentation index is measured with Arteriograph

Trial Locations

Locations (1)

University of Szeged

🇭🇺

Szeged, Csongrád, Hungary

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