The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients

Korea University

Status: Completed

Conditions: Rehabilitation; Respiration; Stroke; Pneumonia; Breathing Exercise

Treatments: Behavioral: conventional stroke rehabilitation program; Device: bedside respiratory muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT03153345

KoreaUAnamHRehab

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Intervention group

Experimental group

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.

Treatment:

Behavioral: conventional stroke rehabilitation program

Device: bedside respiratory muscle training

Control group

Active Comparator group

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.

Treatment:

Behavioral: conventional stroke rehabilitation program