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The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients

Primary Purpose

Stroke, Rehabilitation, Breathing Exercise

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
bedside respiratory muscle training
conventional stroke rehabilitation program
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. older than 18 years of age,
  2. first episode of stroke within three months,
  3. moderate to severe stroke impairment, defined as a NIHSS score from 5-36, and
  4. the ability to follow instructions and engage in the study program.

Exclusion Criteria:

  1. a medical history of persistent cardiopulmonary disease,
  2. other coexisting brain disorders, such as brain tumor,
  3. poorly controlled hypertension, which was defined as a blood pressure higher than 180/100 mmHg during the preceding 24 hours,
  4. severe facial palsy or other oropharyngeal structural abnormality,
  5. severe oral apraxia, and (6) having a tracheostomy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention group

    Control group

    Arm Description

    The intervention group participated in a conventional stroke rehabilitation program, which consisted of joint range of motion exercises, muscle strengthening, gait training, fine motor exercises, and activity of daily living training. This program was performed for 30 minutes twice a day 5 days a week, over for at least 3 weeks. During the same period, the intervention group also took part in bedside respiratory muscle training twice a day for 7 days a week over a 3-week period.

    The control group participated only in a conventional stroke rehabilitation program, which consisted of joint range of motion exercises, muscle strengthening, gait training, fine motor exercises, and activity of daily living training. This program was performed for 30 minutes twice a day 5 days a week, over for at least 3 weeks.

    Outcomes

    Primary Outcome Measures

    functional vital capacity
    functional vital capacity in percent (%)
    Forced expiratory volume
    Forced expiratory volume in one second in percent (%)
    Peak flow
    Peak flow in milliliter

    Secondary Outcome Measures

    Full Information

    First Posted
    May 8, 2017
    Last Updated
    May 12, 2017
    Sponsor
    Korea University Anam Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03153345
    Brief Title
    The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients
    Official Title
    The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2015 (Actual)
    Primary Completion Date
    October 31, 2016 (Actual)
    Study Completion Date
    December 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Korea University Anam Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    Brief Summary
    Objectives: To investigate the efficacy of bedside respiratory muscle training on pulmonary function and stroke-related disabilities in stroke patients. Design: Prospective randomized controlled trial Setting: A single physical medicine and rehabilitation department at a university hospital Participants: Stroke patients in a rehabilitation unit were recruited and randomly assigned to either the intervention group or the control group. Intervention: Both groups participated in a conventional stroke rehabilitation program. During the study period, the intervention group received bedside respiratory muscle training twice a day for three weeks. The respiratory muscle training consisted of (1) a breath stacking exercise, (2) inspiratory muscle training and (3) expiratory muscle training. The participants were evaluated at baseline and again at the end of the study (3 weeks later). Main Outcome Measures: The primary outcomes were measures of pulmonary function: functional vital capacity (FVC), forced expiratory volume in one second (FEV1) and peak flow. Secondary outcomes were stroke-related disabilities assessed by the following: National Institutes of Health Stroke Scale, Modified Barthel Index, Berg Balance Scale, Fugl-Meyer Assessment, the Korean Mini-Mental State Examination, and the incidence of pneumonia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Rehabilitation, Breathing Exercise, Pneumonia, Respiration

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    The intervention group participated in a conventional stroke rehabilitation program, which consisted of joint range of motion exercises, muscle strengthening, gait training, fine motor exercises, and activity of daily living training. This program was performed for 30 minutes twice a day 5 days a week, over for at least 3 weeks. During the same period, the intervention group also took part in bedside respiratory muscle training twice a day for 7 days a week over a 3-week period.
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    The control group participated only in a conventional stroke rehabilitation program, which consisted of joint range of motion exercises, muscle strengthening, gait training, fine motor exercises, and activity of daily living training. This program was performed for 30 minutes twice a day 5 days a week, over for at least 3 weeks.
    Intervention Type
    Device
    Intervention Name(s)
    bedside respiratory muscle training
    Intervention Description
    The program consisted of three sessions: (1) 10 minutes of breath stacking exercise, followed by (2) 10 minutes of inspiratory muscle training using a flow-oriented incentive spirometer and (3) 10 minutes of expiratory muscle training using Acapella vibratory PEP device.
    Intervention Type
    Behavioral
    Intervention Name(s)
    conventional stroke rehabilitation program
    Intervention Description
    The program consisted of joint range of motion exercises, muscle strengthening, gait training, fine motor exercises, and activity of daily living training.
    Primary Outcome Measure Information:
    Title
    functional vital capacity
    Description
    functional vital capacity in percent (%)
    Time Frame
    21 days
    Title
    Forced expiratory volume
    Description
    Forced expiratory volume in one second in percent (%)
    Time Frame
    21 days
    Title
    Peak flow
    Description
    Peak flow in milliliter
    Time Frame
    21 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: older than 18 years of age, first episode of stroke within three months, moderate to severe stroke impairment, defined as a NIHSS score from 5-36, and the ability to follow instructions and engage in the study program. Exclusion Criteria: a medical history of persistent cardiopulmonary disease, other coexisting brain disorders, such as brain tumor, poorly controlled hypertension, which was defined as a blood pressure higher than 180/100 mmHg during the preceding 24 hours, severe facial palsy or other oropharyngeal structural abnormality, severe oral apraxia, and (6) having a tracheostomy.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sung-Bom Pyun, M.D, Ph.D
    Organizational Affiliation
    Department of Physical Medicine and Rehabilitation, Korea University Anam Hospital, Korea University College of Medicine
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients

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