The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients

Not Applicable

Completed

• Conditions: Rehabilitation; Pneumonia; Respiration; Breathing Exercise; Stroke
• Interventions: Behavioral: conventional stroke rehabilitation program; Device: bedside respiratory muscle training

• Registration Number: NCT03153345
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-01
• Primary Completion: 2016-10-31
• Study Completion: 2016-12-31
• Status Verified: 2017-05
• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2017-05-12
• Last Update Submitted: 2017-05-12
• Study First Posted: 2017-05-15
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	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.
Intervention group	bedside respiratory muscle training	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.
Intervention group	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.

Primary Outcome Measures

Name	Time	Method
functional vital capacity	21 days	functional vital capacity in percent (%)
Forced expiratory volume	21 days	Forced expiratory volume in one second in percent (%)
Peak flow	21 days	Peak flow in milliliter