Clinical trial NCT03790410: 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
Overall status: COMPLETED
Phase: NA
Conditions: COPD Postural Control IMT
Keywords: COPD Postural Control IMT
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Maximal Inspiratory Pressure
timeFrame: 6 weeks
measure: Timed Up and Go Test
timeFrame: 6 weeks
measure: Four Square Step Test
timeFrame: 6 weeks
measure: Modified Functional Reach Test
timeFrame: 6 weeks
measure: Modified Lateral Reach Test
timeFrame: 6 weeks
measure: Stand Up Test
timeFrame: 6 weeks
Secondary outcomes:
measure: Sway analysis: COF area (cm2)
timeFrame: 6 weeks
measure: Sway analysis: COF distance (cm)
timeFrame: 6 weeks
measure: Sway analysis: COF variability (cm)
timeFrame: 6 weeks
measure: Sway analysis: COF A-P excursion (cm)
timeFrame: 6 weeks
measure: Sway analysis: COF L-R excursion (cm)
timeFrame: 6 weeks
measure: Thickness of the diaphragm muscle's belly
timeFrame: 6 weeks
measure: Vibration Sense Testing
timeFrame: 6 weeks
measure: Pulse wave velocity
timeFrame: 6 weeks
measure: Augmentation index
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: University of Szeged
state: Csongrád
Study officials:
References: