Stroke Clinical Trial
Official title:
The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients: A Randomized Controlled Trial
Verified date | May 2017 |
Source | Korea University Anam Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 31, 2016 |
Est. primary completion date | October 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Korea University Anam Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | functional vital capacity | functional vital capacity in percent (%) | 21 days | |
Primary | Forced expiratory volume | Forced expiratory volume in one second in percent (%) | 21 days | |
Primary | Peak flow | Peak flow in milliliter | 21 days |
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