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

Primary Purpose

COPD Postural Control IMT

Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Complex pulmonary rehabilitation
Inspiratory muscle training
Sponsored by
Szeged University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD Postural Control IMT focused on measuring COPD Postural Control IMT

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Szeged

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control group-Complex pulmonary rehab.

Inspiratory muscle training group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Sway analysis: COF area (cm2)
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 distance (cm)
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)
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)
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 L-R excursion (cm)
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 belly
The diameter of the diaphragm muscle is assessed by B-mode ultrasound examination using Zonare Z. One Ultrasound System.
Vibration Sense Testing
Tuning fork is used to evaluate the deep sensation.
Pulse wave velocity
Pulse wave velocity is measured with Arteriograph.
Augmentation index
Augmentation index is measured with Arteriograph

Full Information

First Posted
December 20, 2018
Last Updated
October 30, 2020
Sponsor
Szeged University
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1. Study Identification

Unique Protocol Identification Number
NCT03790410
Brief Title
The Effect of Inspiratory Muscle Training on Postural Control in Chronic Obstructive Pulmonary Disease
Official Title
The Effect of Inspiratory Muscle Training on Postural Control in Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Szeged 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Postural Control IMT
Keywords
COPD Postural Control IMT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group-Complex pulmonary rehab.
Arm Type
Active Comparator
Arm Description
Complex pulmonary rehabilitation: The complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings.
Arm Title
Inspiratory muscle training group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Complex pulmonary rehabilitation
Intervention Description
Complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings.
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training
Intervention Description
The training program contains strengthening exercises on the diaphragm muscle.
Primary Outcome Measure Information:
Title
Maximal Inspiratory Pressure
Description
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
Time Frame
6 weeks
Title
Timed Up and Go Test
Description
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.
Time Frame
6 weeks
Title
Four Square Step Test
Description
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.
Time Frame
6 weeks
Title
Modified Functional Reach Test
Description
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.
Time Frame
6 weeks
Title
Modified Lateral Reach Test
Description
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.
Time Frame
6 weeks
Title
Stand Up Test
Description
Stand Up Test: Individual stand up from tailor sit from the floor as fast as possible.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Sway analysis: COF area (cm2)
Description
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.
Time Frame
6 weeks
Title
Sway analysis: COF distance (cm)
Description
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.
Time Frame
6 weeks
Title
Sway analysis: COF variability (cm)
Description
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.
Time Frame
6 weeks
Title
Sway analysis: COF A-P excursion (cm)
Description
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.
Time Frame
6 weeks
Title
Sway analysis: COF L-R excursion (cm)
Description
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.
Time Frame
6 weeks
Title
Thickness of the diaphragm muscle's belly
Description
The diameter of the diaphragm muscle is assessed by B-mode ultrasound examination using Zonare Z. One Ultrasound System.
Time Frame
6 weeks
Title
Vibration Sense Testing
Description
Tuning fork is used to evaluate the deep sensation.
Time Frame
6 weeks
Title
Pulse wave velocity
Description
Pulse wave velocity is measured with Arteriograph.
Time Frame
6 weeks
Title
Augmentation index
Description
Augmentation index is measured with Arteriograph
Time Frame
6 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Szeged
City
Szeged
State/Province
Csongrád
ZIP/Postal Code
6726
Country
Hungary

12. IPD Sharing Statement

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

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