The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients

NCT ID: NCT03153345

Last Updated: 2017-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-01
• Study Completion Date: 2016-12-31

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.

Conditions

Stroke; Rehabilitation; Breathing Exercise; Pneumonia; Respiration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

bedside respiratory muscle training

Intervention Type: DEVICE

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.

conventional stroke rehabilitation program

Intervention Type: BEHAVIORAL

The program consisted of joint range of motion exercises, muscle strengthening, gait training, fine motor exercises, and activity of daily living training.

Control group

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.

Group Type: ACTIVE_COMPARATOR

conventional stroke rehabilitation program

Intervention Type: BEHAVIORAL

The program consisted of joint range of motion exercises, muscle strengthening, gait training, fine motor exercises, and activity of daily living training.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea University Anam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hyun-Joon Yoo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sung-Bom Pyun, M.D, Ph.D

Role: STUDY_CHAIR

Department of Physical Medicine and Rehabilitation, Korea University Anam Hospital, Korea University College of Medicine

Other Identifiers

KoreaUAnamHRehab

Identifier Type: -

Identifier Source: org_study_id