Effects of Respiratory Exercises in Patients With Hemiplegia

Hemiplegia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03763019
• Other study ID #: 54022451-050.05.04
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: February 2020
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia
• Respiratory Abnormality

Intervention

Procedure:
• Conventional rehabilitation
Static and dynamic control of position, balance skills, weight shift, and activities of daily living.
• Respiratory rehabilitation
Forced expiration, forced inspiration (thoracal expansion exercise), coughing exercise, incentive spirometric trainer, diaphragmatic respiration exercise, autogenic drainage, percussion.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif Univesity	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced vital capacity (FVC)	The amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Measured by spirometry. >80% is normal. If the value is lower than the normal limit it indicates either an obstructive or restrictive disease. The lower values show a poorer outcome	6 weeks
Primary	Forced expiratory volume in one second (FEV1)	The maximal amount of air you can forcefully exhale in one second. Measured by spirometry. >80% is normal. If there is an obstruction, this measurement shows the severity of the obstruciton. The lower values show a poorer outcome.	6 weeks
Primary	Tiffeneau-Pinelli index	A calculated ratio used in the diagnosis of obstructive and restrictive lung disease. Calculated as FEV1/FVC. >80% is normal. =80% indicates an obstructive pulmonary disease.	6 weeks
Primary	Forced expiratory flow at 25% and 75% (FEF 25-75%)	The average forced expiratory flow during the mid (25% - 75%) portion of the FVC. Shows small and medium airway obstruction. >70% is normal. It shows the small airways impariment	6 weeks
Primary	Diaphragmatic thickening fraction (TF)	Thickness of the diaphragm is measured from the zone of apposition (subcostal area between anterior axillary line and mid-axillary line) via ultrasonography. After diaphragm thickness in end expiration (thickness in functional residual capacity- TFRC) and in end inspiration (thickness in total lung capacity- TTLC) are obtained. Thickening fraction is calculated as [TTLC-TFRC/TFRC]x100. A higher value shows a better outcome.	6 weeks