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The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients

The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03153345
Enrollment
40
Registered
2017-05-15
Start date
2015-03-01
Completion date
2016-12-31
Last updated
2017-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breathing Exercise, Pneumonia, Rehabilitation, Respiration, Stroke

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.

Interventions

DEVICEbedside 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.

BEHAVIORALconventional 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.

Sponsors

Korea University Anam Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
functional vital capacity21 daysfunctional vital capacity in percent (%)
Forced expiratory volume21 daysForced expiratory volume in one second in percent (%)
Peak flow21 daysPeak flow in milliliter

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026