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Effect Of Breather On Pulmonary And Physical Function In Post Stroke Survivors

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
BREATHER
physiotherapy prgramme for rehabilitation of stroke patients
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Sixty patients were selected from both sexes.Their age were from 50 to 65 years old All patients were medically stable. All patients had the ability to understand and follow simple verbal instructions. All patients were in subacute stage from about 3 to 6 months post lesion. Exclusion Criteria: Patients with severe acute illness. Chronic unstable pulmonary and/or cardiac disease. Impaired level of consciousness and evidence of gross cognitive problems. Patients undergoes chemotherapy. Active hemoptysis, untreated pneumothorax, recent esophageal surgery. Recent oral, facial or skull trauma / surgery, acute sinusitis, epistaxis. Smokers. Any oral dysfunction that interfere with using the breather. Un controlled BP systole more than180 or diastole more than 90.

Sites / Locations

  • Cairo University
  • Faculty of Phsical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

BREATHER GROUP

CONTROL

Arm Description

1)respiratory muscle training for inspiratory and expiratory muscles by the breather device 2)physiotherapy prgramme for stroke rehabilitation which include: Passive stretching exercise, strengthening exercise. Postural control and balance exercise from different positions as quadruped, kneeling, sitting and standing. Gait training.

physiotherapy prgramme for stroke rehabilitation which include: Passive stretching exercise, strengthening exercise. Postural control and balance exercise from different positions as quadruped, kneeling, sitting and standing. Gait training.

Outcomes

Primary Outcome Measures

forced expiratory volium in first second FEV1 in litres
fifty patients will be assessed for their FEV1 using spirometer
foced vital capacity FVC in litres
fifty patients will be assessed for their FVC using spirometer
peak inspiratory flow PIF in litres per second
fifty patients will be assessed for their PIF using spirometer
peak expiratory flow PEF in litres per second
fifty patients will be assessed for their PEF using spirometer

Secondary Outcome Measures

Chest expansion in centimeters using tape measurement
sixty patient willl be assessed for thier chest expansion tape measurement will be used to assess difference in circumference of chest between full expiration and full inspiration.
oxygen saturation in percentage using spirometer
spirometer will be used to indirectly measure saturation of blood by oxygen.
six minute walk distance in metersused to assess functional capacity of patients
the distance walked within six minute will be calculated for every patient
stroke impact scale to assess the effect of stroke on different domains astanderdized score ranging from 0 to 100 is calculated for all domains with higher score indicating a higher quality of life
The stroke impact scale was developed from the perspectives of both patients and care givers. The current stroke impact scale 3.0 is a revised version of the original SIS , with established reliability and validity. The SIS 3.0 contains 59 items measuring eight domains, including strength, hand function, activity of daily living, mobility, communication, emotion, memory/thinking, and participation, with a single item assessing perceived overall recovery from stroke

Full Information

First Posted
December 4, 2022
Last Updated
January 7, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05678816
Brief Title
Effect Of Breather On Pulmonary And Physical Function In Post Stroke Survivors
Official Title
Effect Of Breather On Pulmonary And Physical Function In Post Stroke Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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

5. Study Description

Brief Summary
Stroke is the second major cause of death and disability worldwide with over 13 million new cases annually. Egypt, a low-middle-income country, is the most populated nation in the Middle East with a high overall crude prevalence rate of stroke (963/100,000 inhabitants), accounting for 6.4% of all deaths and the incidence of stroke annually is approximately 150,000-210,000. Stroke has a direct impact on health systems, resulting in high costs, and is also considered a global public health problem due to serious disabilities, functional limitations and compromised quality of life (QoL). The Breather a drug-free, evidence-based inspiratory/expiratory respiratory muscle training (RMT) device used by Dysphagia, COPD, CHF, Parkinson's, and neuromuscular disease patients, as well as children 4+ and adults interested in healthy aging.
Detailed Description
Stroke is a leading cause of death and disability in globally and particularly in low and middle-income countries, and this burden is increasing. The expected spontaneous biological recovery follows the "proportional recovery rule" - most patients recover 70% of their impaired motor or verbal function during the first three months after stroke however, 90% of them have residual deficit. Stroke patients may experience a reduction of up to 50% in respiratory function when compared to age- and gender-matched norms. The reduction in respiratory function can lead to decreased endurance, dyspnea and increased sedentary behaviour, as well as an elevated risk of recurrent stroke. The reduction in respiratory function may also cause aspiration, leading to pneumonia. Previous research showed that pneumonia was an independent risk factor for mortality and a poor prognosis in stroke patients. Research also showed that a reduction in respiratory muscle and abdominal muscle strength contributed to pulmonary and respiratory dysfunction following a stroke. After a stroke, the respiratory center and related motor pathways can directly decrease respiratory muscle strength and subsequently induce a change in breathing patterns. As a result, pneumonia, pulmonary ventilation disorders, lung injury, lung ischemia reperfusion injury, decreased pulmonary compliance, abnormal posture, and obstructive sleep apnea can occur following a stroke. Thus, pulmonary rehabilitation is critical to reducing these complications. The main forms of pulmonary rehabilitation include exercise training, respiratory muscle training, oxygen therapy, noninvasive ventilation, nutrition support, social psychological support, and health education. The inspiratory muscles can be specifically trained, with improvement of both muscle strength and endurance by using the breather device. As result utilizing the breather may help stroke patients recover quickly and avoid respiratory complication.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BREATHER GROUP
Arm Type
Experimental
Arm Description
1)respiratory muscle training for inspiratory and expiratory muscles by the breather device 2)physiotherapy prgramme for stroke rehabilitation which include: Passive stretching exercise, strengthening exercise. Postural control and balance exercise from different positions as quadruped, kneeling, sitting and standing. Gait training.
Arm Title
CONTROL
Arm Type
Other
Arm Description
physiotherapy prgramme for stroke rehabilitation which include: Passive stretching exercise, strengthening exercise. Postural control and balance exercise from different positions as quadruped, kneeling, sitting and standing. Gait training.
Intervention Type
Device
Intervention Name(s)
BREATHER
Intervention Description
respiratory muscle trainer used to strength inspiratory an expiratory muscles through breathing in and out against aresistence which is determined individually according to each patient.
Intervention Type
Other
Intervention Name(s)
physiotherapy prgramme for rehabilitation of stroke patients
Intervention Description
physiotherapy prgramme for rehabilitation of stroke patients which include: Passive stretching exercise, strengthening exercise. Postural control and balance exercise from different positions as quadruped, kneeling, sitting and standing. Gait training.
Primary Outcome Measure Information:
Title
forced expiratory volium in first second FEV1 in litres
Description
fifty patients will be assessed for their FEV1 using spirometer
Time Frame
6 weeks
Title
foced vital capacity FVC in litres
Description
fifty patients will be assessed for their FVC using spirometer
Time Frame
6 weeks
Title
peak inspiratory flow PIF in litres per second
Description
fifty patients will be assessed for their PIF using spirometer
Time Frame
6 weeks
Title
peak expiratory flow PEF in litres per second
Description
fifty patients will be assessed for their PEF using spirometer
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Chest expansion in centimeters using tape measurement
Description
sixty patient willl be assessed for thier chest expansion tape measurement will be used to assess difference in circumference of chest between full expiration and full inspiration.
Time Frame
6 weeks
Title
oxygen saturation in percentage using spirometer
Description
spirometer will be used to indirectly measure saturation of blood by oxygen.
Time Frame
6 weeks
Title
six minute walk distance in metersused to assess functional capacity of patients
Description
the distance walked within six minute will be calculated for every patient
Time Frame
6 weeks
Title
stroke impact scale to assess the effect of stroke on different domains astanderdized score ranging from 0 to 100 is calculated for all domains with higher score indicating a higher quality of life
Description
The stroke impact scale was developed from the perspectives of both patients and care givers. The current stroke impact scale 3.0 is a revised version of the original SIS , with established reliability and validity. The SIS 3.0 contains 59 items measuring eight domains, including strength, hand function, activity of daily living, mobility, communication, emotion, memory/thinking, and participation, with a single item assessing perceived overall recovery from stroke
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sixty patients were selected from both sexes.Their age were from 50 to 65 years old All patients were medically stable. All patients had the ability to understand and follow simple verbal instructions. All patients were in subacute stage from about 3 to 6 months post lesion. Exclusion Criteria: Patients with severe acute illness. Chronic unstable pulmonary and/or cardiac disease. Impaired level of consciousness and evidence of gross cognitive problems. Patients undergoes chemotherapy. Active hemoptysis, untreated pneumothorax, recent esophageal surgery. Recent oral, facial or skull trauma / surgery, acute sinusitis, epistaxis. Smokers. Any oral dysfunction that interfere with using the breather. Un controlled BP systole more than180 or diastole more than 90.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NESREEN AL NAHAS, PROFESSOR
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Cairo University
City
Giza
Country
Egypt
Facility Name
Faculty of Phsical Therapy
City
Giza
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
31658892
Citation
Lindsay MP, Norrving B, Sacco RL, Brainin M, Hacke W, Martins S, Pandian J, Feigin V. World Stroke Organization (WSO): Global Stroke Fact Sheet 2019. Int J Stroke. 2019 Oct;14(8):806-817. doi: 10.1177/1747493019881353. No abstract available.
Results Reference
background
PubMed Identifier
34864736
Citation
Aref H, Zakaria M, Shokri H, Roushdy T, El Basiouny A, El Nahas N. Changing the Landscape of Stroke in Egypt. Cerebrovasc Dis Extra. 2021;11(3):155-159. doi: 10.1159/000521271. Epub 2021 Dec 3.
Results Reference
background
PubMed Identifier
32079017
Citation
Krishnamurthi RV, Ikeda T, Feigin VL. Global, Regional and Country-Specific Burden of Ischaemic Stroke, Intracerebral Haemorrhage and Subarachnoid Haemorrhage: A Systematic Analysis of the Global Burden of Disease Study 2017. Neuroepidemiology. 2020;54(2):171-179. doi: 10.1159/000506396. Epub 2020 Feb 20.
Results Reference
background
PubMed Identifier
28693521
Citation
Gungen BD, Tunc A, Aras YG, Gundogdu AA, Gungen AC, Bal S. Predictors of intensive care unit admission and mortality in patients with ischemic stroke: investigating the effects of a pulmonary rehabilitation program. BMC Neurol. 2017 Jul 11;17(1):132. doi: 10.1186/s12883-017-0912-4.
Results Reference
background

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Effect Of Breather On Pulmonary And Physical Function In Post Stroke Survivors

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