NCT03153345

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Korea University Anam Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Rehabilitation
• Breathing Exercise
• Pneumonia
• Respiration

Interventions

Type	Name	Description
DEVICE	bedside 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.
BEHAVIORAL	conventional 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.

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-10-31
• Completion: 2016-12-31
• First posted: 2017-05-15
• Last updated: 2017-05-15

Regulatory

• FDA-regulated device study