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The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients

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ClinicalTrials.gov Identifier: NCT03153345
Recruitment Status : Completed
First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Hyun-Joon Yoo, Korea University Anam Hospital

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.


Condition or disease Intervention/treatment Phase
Stroke Rehabilitation Breathing Exercise Pneumonia Respiration Device: bedside respiratory muscle training Behavioral: conventional stroke rehabilitation program Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients: A Randomized Controlled Trial
Actual Study Start Date : March 1, 2015
Actual Primary Completion Date : October 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
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.
Device: bedside respiratory muscle training
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.

Behavioral: conventional stroke rehabilitation program
The program consisted of joint range of motion exercises, muscle strengthening, gait training, fine motor exercises, and activity of daily living training.

Active Comparator: Control group
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.
Behavioral: conventional stroke rehabilitation program
The program consisted of joint range of motion exercises, muscle strengthening, gait training, fine motor exercises, and activity of daily living training.




Primary Outcome Measures :
  1. functional vital capacity [ Time Frame: 21 days ]
    functional vital capacity in percent (%)

  2. Forced expiratory volume [ Time Frame: 21 days ]
    Forced expiratory volume in one second in percent (%)

  3. Peak flow [ Time Frame: 21 days ]
    Peak flow in milliliter



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03153345


Sponsors and Collaborators
Korea University Anam Hospital
Investigators
Study Chair: Sung-Bom Pyun, M.D, Ph.D Department of Physical Medicine and Rehabilitation, Korea University Anam Hospital, Korea University College of Medicine

Responsible Party: Hyun-Joon Yoo, Principal Investigator, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT03153345     History of Changes
Other Study ID Numbers: KoreaUAnamHRehab
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Stroke
Pneumonia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections