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The Outcome of Respiratory Muscle Training in Stroke Patients

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ClinicalTrials.gov Identifier: NCT03491111
Recruitment Status : Recruiting
First Posted : April 9, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Mei-Yun Liaw, Chang Gung Memorial Hospital

Brief Summary:

Stroke survivors commonly have respiratory muscle weakness, swallowing disturbance, general weakness, reduced the daily living activities and short of motivation for rehabilitation. Respiratory muscle training (RMT) has been reported to improve the pulmonary function, respiratory muscle strength, exercise capacity, sensation of dyspnea and quality of life in several diseases, but rare in stroke patients. Reviewing previous reports, the protocol, intensity and duration of respiratory muscle training is still variable.

Purpose: To investigate the feasibility and efficacy of respiratory muscle training on cardio-pulmonary function, swallowing function, cough function and reduction of incidence of pneumonia in post-stroke patients.

Methods: A prospective, single blinded, randomized study. Consecutive patients with diagnosis of stroke will be proved by magnetic resonance image or computerized tomography. Stroke patients, aged 35-80 years old, with inspiratory muscle weakness or swallowing disturbance will be enrolled and randomly divided into control group (usual rehabilitation alone) and experimental group [inspiratory muscle training (IMT) group for patients with inspiratory muscle weakness and expiratory muscle strengthening training (EMT) for patients with swallowing disturbance]. Each patients will receive usual rehabilitation.

The investigator expect that RMT will be practical for the restoration of respiratory muscle, swallowing function, cough function and voice quality, thereby reduction of the incidence of pneumonia.


Condition or disease Intervention/treatment Phase
Cerebrovascular Disorders Other: Respiratory muscle training for EMT+IMT Other: Regular Rehabilitation Other: Respiratory muscle training for EMT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Outcome of Respiratory Muscle Training in Stroke Patients: A Prospective Study
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: IMT & EMT
Interventions: Respiratory muscle training for EMT+IMT. Respiratory muscle training for IMT (Inspiratory muscle training)+EMT (Expiratory muscle training). Respiratory muscle breathing training for patients with inspiratory muscle weakness and swallowing disturbance (MIP less than 70% of normal range).
Other: Respiratory muscle training for EMT+IMT
2 times per day and 5 day per week, 6 weeks, training with breathing trainer.

Other: Regular Rehabilitation
Regular Rehabilitation: 2-3 times a week, 6 weeks.

Active Comparator: Control group
Intervention: Non-training group, receive regular rehabilitation. All participants will receive usual rehabilitation care including body positioning instruction, postural correction, breathing control, cough maneuver, respiratory muscle stretch, chest wall mobility exercise and ventilation, fatigue management.
Other: Regular Rehabilitation
Regular Rehabilitation: 2-3 times a week, 6 weeks.

Experimental: EMT group
Intervention: Respiratory muscle training for EMT. Respiratory muscle breathing training for swallowing disturbance. EMT for patients with swallowing disturbance will commence from 15% to 75% of threshold load of an individual's MEP.
Other: Regular Rehabilitation
Regular Rehabilitation: 2-3 times a week, 6 weeks.

Other: Respiratory muscle training for EMT
5 sets, 5 repetition with one or two minute of rest between sets, twice per day, 5 days per week, training with breathing trainer.




Primary Outcome Measures :
  1. MIP (maximal inspiratory pressure) [ Time Frame: At the beginning and the end of program respectively, up to 6 weeks. ]
    MIP(cm H20) is measured after maximal expiration while patients sitting and wearing a nose-clip. For MIP, more negative pressure is better.

  2. MEP (maximal expiratory pressure) [ Time Frame: At the beginning and the end of program respectively, up to 6 weeks. ]
    MEP(cm H20) is measured after maximal inspiration while patients sitting and wearing a nose-clip. For MEP, more positive is better.


Secondary Outcome Measures :
  1. Forced vital capacity, FVC(liter) [ Time Frame: At the beginning and the end of program respectively, up to 6 weeks. ]
    Pulmonary functional test, the determination of the vital capacity from a maximally forced expiratory effort.

  2. Forced vital capacity, FVC(%pred)(liter) [ Time Frame: At the beginning and the end of program respectively, up to 6 weeks. ]
    Pulmonary functional test, the determination of the vital capacity from a maximally forced expiratory effort.

  3. Forced expiratory volume 1/Forced vital capacity, FEV1/FVC(%) [ Time Frame: At the beginning and the end of program respectively, up to 6 weeks. ]
    Pulmonary functional test, a calculated ratio used in the diagnosis of obstructive and restrictive lung disease.

  4. Maximal mid-expiratory flow, MMEF(%) [ Time Frame: At the beginning and the end of program respectively, up to 6 weeks. ]
    Pulmonary functional test, the peak of expiratory flow as taken from the flow-volume curve and measured in liters per second.

  5. Peak cough flow(liter/min) [ Time Frame: At the beginning and the end of program respectively, up to 6 weeks. ]
    Maximum speed of expiration

  6. Resting heart rate [ Time Frame: At the beginning and the end of program respectively, up to 6 weeks. ]
    Heart rate of patient during resting.

  7. Resting respiratory rate [ Time Frame: At the beginning and the end of program respectively, up to 6 weeks. ]
    Respiratory rate of patient during resting.

  8. Functional Oral Intake Scale [ Time Frame: At the beginning and the end of program respectively, up to 6 weeks. ]
    Level 1: Nothing by mouth. Level 2: Tube dependent with minimal attempts of food or liquid. Level 3: Tube dependent with consistent oral intake of food or liquid. Level 4: Total oral diet of a single consistency. Level 5: Total oral diet with multiple consistencies, but requiring special preparation or compensations.Level 6: Total oral diet with multiple consistencies without special preparation, but with specific food limitations. Level 7: Total oral diet with no restrictions. Level 1 to level 7.

  9. Borg's Scale [ Time Frame: At the beginning and the end of program respectively, up to 6 weeks. ]
    Modified Borg scale (0.5 to 10)

  10. Fatigue Assessment Scale [ Time Frame: At the beginning and the end of program respectively, up to 6 weeks. ]
    Score: 5-50. 1 = Never, 2 = Sometimes; 3 = Regularly; 4 = Often and 5 = Always. 10 items.



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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients identified as stroke and capable of performing voluntary respiratory maneuvers.

Exclusion Criteria:

  • Increased intracranial pressure
  • Uncontrolled hypertension
  • Complicated arrhythmia
  • Decompensated heart failure
  • Unstable angina
  • Myocardial infarction in the preceding 3 months
  • Pneumothorax, bullae/blebs or infection.

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): NCT03491111


Contacts
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Contact: Liaw Mei-Yun, MD 886-7-7317123 ext 6286 meiyunliaw@cgmh.org.tw

Locations
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Taiwan
Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital. Recruiting
Kaohsiung, Taiwan, 83305
Contact: Mei-Yun Liaw, MD    886-7-7317123 ext 6286    meiyunliaw@cgmh.org.tw   
Contact: Ling-Yi Wang, MD    886-7-7317123 ext 6286    s801121@cloud.cgmh.org.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Liaw Mei-Yun, MD Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mei-Yun Liaw, Medical doctor in Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03491111    
Other Study ID Numbers: CMRPG8E0911
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Mei-Yun Liaw, Chang Gung Memorial Hospital:
Cerebrovascular disease
respiratory muscle training
spirometry
peak flow
maximal inspiratory pressure, maximal expiratory pressure
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases