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.

Study Overview

• Status: Completed
• Conditions: COPD Postural Control IMT
• Intervention / Treatment: Other: Complex pulmonary rehabilitation; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Csongrád
    • Szeged, Csongrád, Hungary, 6726
      • University Of Szeged

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control group-Complex pulmonary rehab.; Complex pulmonary rehabilitation: The complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings.	Other: Complex pulmonary rehabilitation; Complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings.
ACTIVE_COMPARATOR: 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.	Other: Complex pulmonary rehabilitation; Complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings.; Other: Inspiratory muscle training; The training program contains strengthening exercises on the diaphragm muscle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 weeks
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.	6 weeks
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.	6 weeks
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.	6 weeks
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.	6 weeks
Stand Up Test	Stand Up Test: Individual stand up from tailor sit from the floor as fast as possible.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks
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.	6 weeks
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.	6 weeks
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.	6 weeks
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.	6 weeks
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.	6 weeks
Vibration Sense Testing	Tuning fork is used to evaluate the deep sensation.	6 weeks
Pulse wave velocity	Pulse wave velocity is measured with Arteriograph.	6 weeks
Augmentation index	Augmentation index is measured with Arteriograph	6 weeks

Collaborators and Investigators

• Sponsor: Szeged University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2017
• Primary Completion (ACTUAL): February 28, 2020
• Study Completion (ACTUAL): February 28, 2020

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: December 27, 2018
• First Posted (ACTUAL): December 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: COPD Postural Control IMT
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: COPD IMT PC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No