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Effects of Respiratory Exercises in Patients With Hemiplegia

Primary Purpose

Hemiplegia, Respiratory Abnormality

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional rehabilitation
Respiratory rehabilitation
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hemiplegia focused on measuring hemiplegia, respiratory function tests, respiratory exercises, diaphragm ultrasonography

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bezmialem Vakıf Univesity

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Respiratory rehabilitation

Conventional rehabilitation

Arm Description

Conventional rehabilitation program aiming to normalize movement patterns and minimize spasticity. Including static and dynamic control of position, balance skills, weight shift, and activities of daily living. 45 minutes, once daily. Respiratory exercises 30 minutes, once daily, (incentive spirometric trainer, forced expiration, percussion, postural drainage etc.)

Conventional rehabilitation program aiming to normalize movement patterns and minimize spasticity. Including static and dynamic control of position, balance skills, weight shift, and activities of daily living. 45 minutes, once daily.

Outcomes

Primary Outcome Measures

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
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.
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.
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
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.

Secondary Outcome Measures

Full Information

First Posted
November 30, 2018
Last Updated
February 3, 2020
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT03763019
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
February 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia, Respiratory Abnormality
Keywords
hemiplegia, respiratory function tests, respiratory exercises, diaphragm ultrasonography

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Respiratory rehabilitation
Arm Type
Active Comparator
Arm Description
Conventional rehabilitation program aiming to normalize movement patterns and minimize spasticity. Including static and dynamic control of position, balance skills, weight shift, and activities of daily living. 45 minutes, once daily. Respiratory exercises 30 minutes, once daily, (incentive spirometric trainer, forced expiration, percussion, postural drainage etc.)
Arm Title
Conventional rehabilitation
Arm Type
Placebo Comparator
Arm Description
Conventional rehabilitation program aiming to normalize movement patterns and minimize spasticity. Including static and dynamic control of position, balance skills, weight shift, and activities of daily living. 45 minutes, once daily.
Intervention Type
Procedure
Intervention Name(s)
Conventional rehabilitation
Intervention Description
Static and dynamic control of position, balance skills, weight shift, and activities of daily living.
Intervention Type
Procedure
Intervention Name(s)
Respiratory rehabilitation
Intervention Description
Forced expiration, forced inspiration (thoracal expansion exercise), coughing exercise, incentive spirometric trainer, diaphragmatic respiration exercise, autogenic drainage, percussion.
Primary Outcome Measure Information:
Title
Forced vital capacity (FVC)
Description
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
Time Frame
6 weeks
Title
Forced expiratory volume in one second (FEV1)
Description
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.
Time Frame
6 weeks
Title
Tiffeneau-Pinelli index
Description
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.
Time Frame
6 weeks
Title
Forced expiratory flow at 25% and 75% (FEF 25-75%)
Description
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
Time Frame
6 weeks
Title
Diaphragmatic thickening fraction (TF)
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozan Volkan Yurdakul, MD
Organizational Affiliation
Bezmialem University
Official's Role
Study Director
Facility Information:
Facility Name
Bezmialem Vakıf Univesity
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24639923
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.
Results Reference
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PubMed Identifier
28284044
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.
Results Reference
background
PubMed Identifier
29373153
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.
Results Reference
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Effects of Respiratory Exercises in Patients With Hemiplegia

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