Clinical trial NCT03763019: Effects of Respiratory Exercises in Patients With Hemiplegia
Official title: Correlation of Pulmonary Function Test and Ultrasonographic Diaphragm Measurements in Patients With Hemiplegia and Investigation of the Effects of Respiratory Exercises on These Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia
Respiratory Abnormality
Keywords: hemiplegia
respiratory function tests
respiratory exercises
diaphragm ultrasonography
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study evaluates the effects of respiratory exercises on respiratory function test parameters and ultrasonographic diaphragmatic measurements. Half of the hemiplegic patients will receive respiratory and neurophysiological exercises, while other half will receive only neurophysiological exercises.

Detailed description: After stroke, diaphragm, the most important muscle of respiration, is wasted as well as the other muscles of the affected side.

Ultrasonography is a non-invasive, practical, low cost utility that may measure the thickness of diaphragm in maximum expiration and inspiration thus examining the functionality of the muscle. Correlation between respiratory functional tests and diaphragm ultrasonography has been proven in recent literature. In this manner, the aim of this study is twofold. First is to determine whether ultrasonography can be used practically to evaluate the respiratory functions of the patients after stroke. Respiratory function tests will be used for the correlation analysis. Second is to evaluate the effectiveness of respiratory exercises via diaphragm ultrasonography and respiratory function tests.

Eligibility criteria: Inclusion Criteria:

* Stroke confirmed radiologically
* Unilateral hemiplegia
* First stroke episode
* Mini Mental score ≥ 24

Exclusion Criteria:

* Unable to consent and understand
* Chronic cardiac disease
* Pulmonary disease (asthma, restrictive or obstructive pulmonary disease)
* Facial paralysis
* History of thoracic or abdominal surgery
* Being alcoholic
* Using psychotropic drugs

Primary outcomes:
measure: Forced vital capacity (FVC)
timeFrame: 6 weeks
measure: Forced expiratory volume in one second (FEV1)
timeFrame: 6 weeks
measure: Tiffeneau-Pinelli index
timeFrame: 6 weeks
measure: Forced expiratory flow at 25% and 75% (FEF 25-75%)
timeFrame: 6 weeks
measure: Diaphragmatic thickening fraction (TF)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf Univesity
Study officials:
affiliation: Bezmialem University
name: Ozan Volkan Yurdakul, MD
role: STUDY_DIRECTOR
References:
citation: Jung KJ, Park JY, Hwang DW, Kim JH, Kim JH. Ultrasonographic diaphragmatic motion analysis and its correlation with pulmonary function in hemiplegic stroke patients. Ann Rehabil Med. 2014 Feb;38(1):29-37. doi: 10.5535/arm.2014.38.1.29. Epub 2014 Feb 25.
citation: Kim M, Lee K, Cho J, Lee W. Diaphragm Thickness and Inspiratory Muscle Functions in Chronic Stroke Patients. Med Sci Monit. 2017 Mar 11;23:1247-1253. doi: 10.12659/msm.900529.
citation: Cardenas LZ, Santana PV, Caruso P, Ribeiro de Carvalho CR, Pereira de Albuquerque AL. Diaphragmatic Ultrasound Correlates with Inspiratory Muscle Strength and Pulmonary Function in Healthy Subjects. Ultrasound Med Biol. 2018 Apr;44(4):786-793. doi: 10.1016/j.ultrasmedbio.2017.11.020. Epub 2018 Jan 17.