The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03153345
• Other study ID #: KoreaUAnamHRehab
• Status: Completed
• Phase: N/A
• First received: May 8, 2017
• Last updated: May 12, 2017
• Start date: March 1, 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: May 2017
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2016
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breathing Exercise
• Pneumonia
• Rehabilitation
• Respiration
• Stroke

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional vital capacity	functional vital capacity in percent (%)	21 days
Primary	Forced expiratory volume	Forced expiratory volume in one second in percent (%)	21 days
Primary	Peak flow	Peak flow in milliliter	21 days