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Completed

NCT Number: NCT03790410

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

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.

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Key information

Conditions

COPD Postural Control IMT

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Szeged

Szeged, Csongrád megye, 6726, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Complex pulmonary rehabilitation

Other

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

Inspiratory Muscle Training

Other

The training program contains strengthening exercises on the diaphragm muscle.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  1. Sway analysis: COF area (cm2)

    Time frame: 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.

  2. Sway analysis: COF distance (cm)

    Time frame: 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.

  3. Sway analysis: COF variability (cm)

    Time frame: 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.

  4. Sway analysis: COF A-P excursion (cm)

    Time frame: 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.

  5. Sway analysis: COF L-R excursion (cm)

    Time frame: 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.

  6. Thickness of the diaphragm muscle's belly

    Time frame: 6 weeks

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

  7. Vibration Sense Testing

    Time frame: 6 weeks

    Tuning fork is used to evaluate the deep sensation.

  8. Pulse wave velocity

    Time frame: 6 weeks

    Pulse wave velocity is measured with Arteriograph.

  9. Augmentation index

    Time frame: 6 weeks

    Augmentation index is measured with Arteriograph

Sponsors and collaborators

Lead sponsor

Szeged University

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 31, 2018
Registry last updated
Nov 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.