The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients: A Randomized Controlled Trial
| Registry | NCT03153345 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 40 (Actual) |
| Sponsor | Korea University Anam Hospital (Other) |
| Conditions | Stroke, Rehabilitation, Breathing Exercise, Pneumonia, Respiration |
| Interventions | bedside respiratory muscle training, conventional stroke rehabilitation program (Device, behavioral) |
| Dates | start 2015-03-01, primary completion 2016-10-31, completion 2016-12-31, first posted 2017-05-15, last updated 2017-05-15 |
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All trials for Stroke All trials for Rehabilitation All trials of bedside respiratory muscle training All trials of conventional stroke rehabilitation program
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention group | Experimental | Device: bedside respiratory muscle training; Behavioral: conventional stroke rehabilitation program | 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. |
| Control group | Active comparator | Behavioral: conventional stroke rehabilitation program | 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. |
Sex: All, ages: 18 Years to any
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.