Effects of Respiratory Exercises in Patients With Hemiplegia

Sponsor
Bezmialem Vakif University (Other)
Overall Status
Completed
CT.gov ID
NCT03763019
Collaborator
(none)
40
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2
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Conventional rehabilitation
  • Procedure: Respiratory rehabilitation
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
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
Actual Study Start Date :
May 1, 2019
Actual Primary Completion Date :
Feb 1, 2020
Actual Study Completion Date :
Feb 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Respiratory rehabilitation

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.)

Procedure: Conventional rehabilitation
Static and dynamic control of position, balance skills, weight shift, and activities of daily living.

Procedure: Respiratory rehabilitation
Forced expiration, forced inspiration (thoracal expansion exercise), coughing exercise, incentive spirometric trainer, diaphragmatic respiration exercise, autogenic drainage, percussion.

Placebo Comparator: Conventional rehabilitation

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.

Procedure: Conventional rehabilitation
Static and dynamic control of position, balance skills, weight shift, and activities of daily living.

Outcome Measures

Primary Outcome Measures

  1. Forced vital capacity (FVC) [6 weeks]

    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

  2. Forced expiratory volume in one second (FEV1) [6 weeks]

    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.

  3. Tiffeneau-Pinelli index [6 weeks]

    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.

  4. Forced expiratory flow at 25% and 75% (FEF 25-75%) [6 weeks]

    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

  5. Diaphragmatic thickening fraction (TF) [6 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bezmialem Vakıf Univesity Istanbul Turkey 34093

Sponsors and Collaborators

  • Bezmialem Vakif University

Investigators

  • Study Director: Ozan Volkan Yurdakul, MD, Bezmialem University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bezmialem Vakif University
ClinicalTrials.gov Identifier:
NCT03763019
Other Study ID Numbers:
  • 54022451-050.05.04
First Posted:
Dec 4, 2018
Last Update Posted:
Feb 5, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bezmialem Vakif University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 5, 2020