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Effects of Respiratory Training on Respiratory and Functional Performance in Patients With Stroke

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ClinicalTrials.gov Identifier: NCT02726685
Recruitment Status : Not yet recruiting
First Posted : April 4, 2016
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Chung-Hao Chuang, Chung Shan Medical University

Brief Summary:
The purpose of the research is to investigate the effects of respiratory training on respiratory and functional performance in patients with stroke.

Condition or disease Intervention/treatment Phase
Stroke Other: respiratory training. Other: sham training. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Respiratory Training on Respiratory and Functional Performance in Patients With Stroke
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: RT (respiratory training) group
Besides traditional rehabilitation therapy, subjects also receive 12-week respiratory training.
Other: respiratory training.
breathing exercise.

Sham Comparator: Control group
Besides traditional rehabilitation therapy, subjects receive 12-week sham training unrelated to respiratory function.
Other: sham training.
range of motion (ROM) exercise, stretching exercise or positioning exercise.




Primary Outcome Measures :
  1. Diaphragm Thickness. [ Time Frame: change from baseline diaphragm thickness at 12, 16, 24, 36 weeks. ]
    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.

  2. Incidence of Pneumonia. [ Time Frame: change from baseline incidence of pneumonia at 12, 16, 24, 36 weeks. ]
    This study will observe the incidence of pneumonia of two groups in the 36-week research course.

  3. Brunnstrom's motor recovery stages. [ Time Frame: change from baseline Brunnstrom's stages at 12, 16, 24, 36 weeks. ]
    The six sequential stages of motor recovery through which the hemiplegic upper and lower extremities progress used as a method for assessing recovery.

  4. Stroke Rehabilitation Assessment of Movement scale; STREAM. [ Time Frame: change from baseline STREAM scores at 12, 16, 24, 36 weeks. ]
    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.

  5. Stroke-Specific Quality of Life scale; SS-QOL. [ Time Frame: change from baseline SS-QOL scores at 12, 16, 24, 36 weeks. ]
    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.

  6. Stroke Impact Scale; SIS 3.0. [ Time Frame: change from baseline SIS 3.0 scores at 12, 16, 24, 36 weeks. ]
    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.

  7. Twelve-Minute Walk Test. [ Time Frame: change from baseline Twelve-Minute Walk Test scores at 12, 16, 24, 36 weeks. ]
    The distance (in meters) that a subject can walk within twelve minutes is evaluated.

  8. Forced Vital Capacity (FVC) in liters. [ Time Frame: change from baseline FVC at 12, 16, 24, 36 weeks. ]
    Resting spirometry of FVC will be performed on a spirometer.

  9. Vital Capacity (VC) in liters. [ Time Frame: change from baseline VC at 12, 16, 24, 36 weeks. ]
    Resting spirometry of VC will be performed on a spirometer.

  10. Forced Expiratory Volume at 1 second (FEV1) in liters. [ Time Frame: change from baseline FEV1 at 12, 16, 24, 36 weeks. ]
    Resting spirometry of FEV1 will be performed on a spirometer.

  11. Ratio of FEV1 to FVC (FEV1/FVC). [ Time Frame: change from baseline FEV1/FVC ratio at 12, 16, 24, 36 weeks. ]
    Resting spirometry of FEV1/FVC ratio will be performed on a spirometer.

  12. Forced Expiratory Flow rate 25-75% (FEF 25-75%) in liters per minute. [ Time Frame: change from baseline FEF 25-75% at 12, 16, 24, 36 weeks. ]
    Resting spirometry of FEF 25-75% will be performed on a spirometer.

  13. Peak Expiratory Flow Rate (PEFR) in liters per minute. [ Time Frame: change from baseline PEFR at 12, 16, 24, 36 weeks. ]
    Resting spirometry of PEFR will be performed on a spirometer.

  14. Maximum Inspiratory Pressure (PImax) in centimeters of water pressure (cmH2O). [ Time Frame: change from baseline PImax at 12, 16, 24, 36 weeks. ]
    Resting spirometry of PImax will be performed on a spirometer.

  15. Maximum Expiratory Pressures (PEmax) in centimeters of water pressure (cmH2O). [ Time Frame: change from baseline PEmax at 12, 16, 24, 36 weeks. ]
    Resting spirometry of PEmax will be performed on a spirometer.

  16. Maximum Voluntary Ventilation (MVV) in liters per minute. [ Time Frame: change from baseline MVV at 12, 16, 24, 36 weeks. ]
    Resting spirometry of MVV will be performed on a spirometer.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02726685


Contacts
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Contact: Chung-Hao Chuang, PhD study. +886-95253993 chuang5959@yahoo.com.tw
Contact: Chun-Hou Wang, Professor. +886-4-24730022 ext 11015 wangcsmu@gmail.com

Locations
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Taiwan
Chung Shan Medical University Hospital Not yet recruiting
Taichung, Taiwan, 42010
Contact: Chung-Hao Chuang, PhD study.    +886-952539993    chuang5959@yahoo.com.tw   
Contact: Chun-Hou Wang, Professor.    +886-4-24730022 ext 11015    wangcsmu@gmail.com   
Sponsors and Collaborators
Chung Shan Medical University
Investigators
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Principal Investigator: Chung-Hao Chuang, PhD study. Chung Shan Medical University

Publications:
Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011 Feb 1;123(4):e18-e209. doi: 10.1161/CIR.0b013e3182009701. Epub 2010 Dec 15. Erratum in: Circulation. 2011 Oct 18;124(16):e426. Circulation. 2011 Feb 15;123(6):e240.

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Responsible Party: Chung-Hao Chuang, Director of Rehabilitation Therapy Department, Chung Shan Medical University
ClinicalTrials.gov Identifier: NCT02726685     History of Changes
Other Study ID Numbers: CSH-2016-A-006
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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

Keywords provided by Chung-Hao Chuang, Chung Shan Medical University:
respiratory training
functional performance

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases