Back to resultsEffects of Respiratory Training on Respiratory and Functional Performance in Patients With Stroke
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
respiratory training.
sham training.
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring respiratory training, functional performance
Eligibility Criteria
Inclusion Criteria:
- first episode of unilateral stroke.
- the definition of stroke was according to the World Health Organization (WHO) criteria (Hatano 1976), confirmed by computerized tomography (CT) or magnetic resonance imaging (MRI).
- older than 20 years.
- had maximum inspiratory pressure (MIP) values lower than 90% of those predicted and adjusted for age and sex.
- facial palsy, which could not prevent proper labial occlusion.
- ability to understand and follow simple verbal instructions.
- no receptive aphasia.
- not undergone thoracic or abdominal surgery.
Exclusion Criteria:
- unable to perform the tests.
- impaired level of consciousness and evidence of gross cognitive impairment.
- excluded patients with comorbidities of respiratory system disease (e.g. chronic obstructive pulmonary disease, asthma, cystic fibrosis), or other diseases leading to the impairment of respiratory muscle (e.g. myasthenia gravis).
Sites / Locations
- Chung Shan Medical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
RT (respiratory training) group
Control group
Arm Description
Besides traditional rehabilitation therapy, subjects also receive 12-week respiratory training.
Besides traditional rehabilitation therapy, subjects receive 12-week sham training unrelated to respiratory function.
Outcomes
Primary Outcome Measures
Diaphragm Thickness.
In this study, the mid axillary lines between ribs 8 and 9 on both sides will be checked in a standing posture, then the chest wall is perpendicularly illuminated by a curved array 2-5 MHz transducer (Siemens Sololine G40) in an upright sitting position to observe the region between rib 8 and rib 9 in 2D images. The diaphragm thickness is measured as the distance between two parallel lines that appear bright in the middle of the pleura and in the middle peritoneum.
Incidence of Pneumonia.
This study will observe the incidence of pneumonia of two groups in the 36-week research course.
Brunnstrom's motor recovery stages.
The six sequential stages of motor recovery through which the hemiplegic upper and lower extremities progress used as a method for assessing recovery.
Stroke Rehabilitation Assessment of Movement scale; STREAM.
The STREAM scale is used to evaluate the recovery of voluntary movement and basic mobility following stroke. The scale consists of 30 items or test movements that are equally distributed among 3 subscales: upper-limb movements, lower-limb movements, and basic mobility items.
Stroke-Specific Quality of Life scale; SS-QOL.
The SS-QOL scale is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke. It consists of twelve commonly affected domains (energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity functioning, vision, and work/productivity) and 49 items.
Stroke Impact Scale; SIS 3.0.
The SIS 3.0 is a stroke-specific, self-report, health status measure. The scale includes 59 items and assesses 8 domains. It was designed to assess multidimensional stroke outcomes, including strength, hand function, activities of daily living/instrumental activities of daily living (ADL/IADL), mobility, communication, emotion, memory and thinking, and participation.
Twelve-Minute Walk Test.
The distance (in meters) that a subject can walk within twelve minutes is evaluated.
Forced Vital Capacity (FVC) in liters.
Resting spirometry of FVC will be performed on a spirometer.
Vital Capacity (VC) in liters.
Resting spirometry of VC will be performed on a spirometer.
Forced Expiratory Volume at 1 second (FEV1) in liters.
Resting spirometry of FEV1 will be performed on a spirometer.
Ratio of FEV1 to FVC (FEV1/FVC).
Resting spirometry of FEV1/FVC ratio will be performed on a spirometer.
Forced Expiratory Flow rate 25-75% (FEF 25-75%) in liters per minute.
Resting spirometry of FEF 25-75% will be performed on a spirometer.
Peak Expiratory Flow Rate (PEFR) in liters per minute.
Resting spirometry of PEFR will be performed on a spirometer.
Maximum Inspiratory Pressure (PImax) in centimeters of water pressure (cmH2O).
Resting spirometry of PImax will be performed on a spirometer.
Maximum Expiratory Pressures (PEmax) in centimeters of water pressure (cmH2O).
Resting spirometry of PEmax will be performed on a spirometer.
Maximum Voluntary Ventilation (MVV) in liters per minute.
Resting spirometry of MVV will be performed on a spirometer.
Secondary Outcome Measures
Full Information
NCT ID
NCT02726685
First Posted
March 18, 2016
Last Updated
July 16, 2018
Sponsor
Chung Shan Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02726685
Brief Title
Effects of Respiratory Training on Respiratory and Functional Performance in Patients With Stroke
Official Title
Effects of Respiratory Training on Respiratory and Functional Performance in Patients With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Anticipated)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the research is to investigate the effects of respiratory training on respiratory and functional performance in patients with stroke.
Detailed Description
Stroke ranks third in the global cause of death, behind cancer and coronary heart disease. Stroke is also the third largest cause of death in Taiwan in 2014. Stroke patients in the course of exercise are in addition to muscle weakness and reduced endurance, but usually also accompanied by respiratory damage. From past studies have shown that stroke patients whose respiratory function has significant change, such as decreased respiratory muscle strength, reduced respiratory movement of the affected hemithorax, declined in maximum breathing pressure and decreased amplitude of diaphragmatic movements on the paralyzed side. But whether respiratory training can improve respiratory and functional performance of stroke patients, because of the limited research results could not be confirmed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
respiratory training, functional performance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RT (respiratory training) group
Arm Type
Experimental
Arm Description
Besides traditional rehabilitation therapy, subjects also receive 12-week respiratory training.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Besides traditional rehabilitation therapy, subjects receive 12-week sham training unrelated to respiratory function.
Intervention Type
Other
Intervention Name(s)
respiratory training.
Intervention Description
breathing exercise.
Intervention Type
Other
Intervention Name(s)
sham training.
Intervention Description
range of motion (ROM) exercise, stretching exercise or positioning exercise.
Primary Outcome Measure Information:
Title
Diaphragm Thickness.
Description
In this study, the mid axillary lines between ribs 8 and 9 on both sides will be checked in a standing posture, then the chest wall is perpendicularly illuminated by a curved array 2-5 MHz transducer (Siemens Sololine G40) in an upright sitting position to observe the region between rib 8 and rib 9 in 2D images. The diaphragm thickness is measured as the distance between two parallel lines that appear bright in the middle of the pleura and in the middle peritoneum.
Time Frame
change from baseline diaphragm thickness at 12, 16, 24, 36 weeks.
Title
Incidence of Pneumonia.
Description
This study will observe the incidence of pneumonia of two groups in the 36-week research course.
Time Frame
change from baseline incidence of pneumonia at 12, 16, 24, 36 weeks.
Title
Brunnstrom's motor recovery stages.
Description
The six sequential stages of motor recovery through which the hemiplegic upper and lower extremities progress used as a method for assessing recovery.
Time Frame
change from baseline Brunnstrom's stages at 12, 16, 24, 36 weeks.
Title
Stroke Rehabilitation Assessment of Movement scale; STREAM.
Description
The STREAM scale is used to evaluate the recovery of voluntary movement and basic mobility following stroke. The scale consists of 30 items or test movements that are equally distributed among 3 subscales: upper-limb movements, lower-limb movements, and basic mobility items.
Time Frame
change from baseline STREAM scores at 12, 16, 24, 36 weeks.
Title
Stroke-Specific Quality of Life scale; SS-QOL.
Description
The SS-QOL scale is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke. It consists of twelve commonly affected domains (energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity functioning, vision, and work/productivity) and 49 items.
Time Frame
change from baseline SS-QOL scores at 12, 16, 24, 36 weeks.
Title
Stroke Impact Scale; SIS 3.0.
Description
The SIS 3.0 is a stroke-specific, self-report, health status measure. The scale includes 59 items and assesses 8 domains. It was designed to assess multidimensional stroke outcomes, including strength, hand function, activities of daily living/instrumental activities of daily living (ADL/IADL), mobility, communication, emotion, memory and thinking, and participation.
Time Frame
change from baseline SIS 3.0 scores at 12, 16, 24, 36 weeks.
Title
Twelve-Minute Walk Test.
Description
The distance (in meters) that a subject can walk within twelve minutes is evaluated.
Time Frame
change from baseline Twelve-Minute Walk Test scores at 12, 16, 24, 36 weeks.
Title
Forced Vital Capacity (FVC) in liters.
Description
Resting spirometry of FVC will be performed on a spirometer.
Time Frame
change from baseline FVC at 12, 16, 24, 36 weeks.
Title
Vital Capacity (VC) in liters.
Description
Resting spirometry of VC will be performed on a spirometer.
Time Frame
change from baseline VC at 12, 16, 24, 36 weeks.
Title
Forced Expiratory Volume at 1 second (FEV1) in liters.
Description
Resting spirometry of FEV1 will be performed on a spirometer.
Time Frame
change from baseline FEV1 at 12, 16, 24, 36 weeks.
Title
Ratio of FEV1 to FVC (FEV1/FVC).
Description
Resting spirometry of FEV1/FVC ratio will be performed on a spirometer.
Time Frame
change from baseline FEV1/FVC ratio at 12, 16, 24, 36 weeks.
Title
Forced Expiratory Flow rate 25-75% (FEF 25-75%) in liters per minute.
Description
Resting spirometry of FEF 25-75% will be performed on a spirometer.
Time Frame
change from baseline FEF 25-75% at 12, 16, 24, 36 weeks.
Title
Peak Expiratory Flow Rate (PEFR) in liters per minute.
Description
Resting spirometry of PEFR will be performed on a spirometer.
Time Frame
change from baseline PEFR at 12, 16, 24, 36 weeks.
Title
Maximum Inspiratory Pressure (PImax) in centimeters of water pressure (cmH2O).
Description
Resting spirometry of PImax will be performed on a spirometer.
Time Frame
change from baseline PImax at 12, 16, 24, 36 weeks.
Title
Maximum Expiratory Pressures (PEmax) in centimeters of water pressure (cmH2O).
Description
Resting spirometry of PEmax will be performed on a spirometer.
Time Frame
change from baseline PEmax at 12, 16, 24, 36 weeks.
Title
Maximum Voluntary Ventilation (MVV) in liters per minute.
Description
Resting spirometry of MVV will be performed on a spirometer.
Time Frame
change from baseline MVV at 12, 16, 24, 36 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
first episode of unilateral stroke.
the definition of stroke was according to the World Health Organization (WHO) criteria (Hatano 1976), confirmed by computerized tomography (CT) or magnetic resonance imaging (MRI).
older than 20 years.
had maximum inspiratory pressure (MIP) values lower than 90% of those predicted and adjusted for age and sex.
facial palsy, which could not prevent proper labial occlusion.
ability to understand and follow simple verbal instructions.
no receptive aphasia.
not undergone thoracic or abdominal surgery.
Exclusion Criteria:
unable to perform the tests.
impaired level of consciousness and evidence of gross cognitive impairment.
excluded patients with comorbidities of respiratory system disease (e.g. chronic obstructive pulmonary disease, asthma, cystic fibrosis), or other diseases leading to the impairment of respiratory muscle (e.g. myasthenia gravis).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chung-Hao Chuang, PhD study.
Phone
+886-95253993
Email
chuang5959@yahoo.com.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Chun-Hou Wang, Professor.
Phone
+886-4-24730022
Ext
11015
Email
wangcsmu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chung-Hao Chuang, PhD study.
Organizational Affiliation
Chung Shan Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
42010
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chung-Hao Chuang, PhD study.
Phone
+886-952539993
Email
chuang5959@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Chun-Hou Wang, Professor.
Phone
+886-4-24730022
Ext
11015
Email
wangcsmu@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
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Effects of Respiratory Training on Respiratory and Functional Performance in Patients With Stroke
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