The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients

NCT03153345 | Completed FDA Device

• 1 other identifier: KoreaUAnamHRehab
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• functional vital capacity

  functional vital capacity in percent (%)

  21 days

• Forced expiratory volume

  Forced expiratory volume in one second in percent (%)

  21 days

• Peak flow

  Peak flow in milliliter

  21 days

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

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

Control group

ACTIVE COMPARATOR

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.

Behavioral: conventional stroke rehabilitation program

Interventions

bedside respiratory muscle training 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.

Intervention group

conventional stroke rehabilitation program 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; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• older than 18 years of age,
• first episode of stroke within three months,
• moderate to severe stroke impairment, defined as a NIHSS score from 5-36, and
• the ability to follow instructions and engage in the study program.

You may not qualify if:

• a medical history of persistent cardiopulmonary disease,
• other coexisting brain disorders, such as brain tumor,
• poorly controlled hypertension, which was defined as a blood pressure higher than 180/100 mmHg during the preceding 24 hours,
• severe facial palsy or other oropharyngeal structural abnormality,
• severe oral apraxia, and (6) having a tracheostomy.

Sponsors & Collaborators

• Korea University Anam Hospital: lead

MeSH Terms

Conditions

Stroke; Pneumonia; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sung-Bom Pyun, M.D, Ph.D

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 15, 2017
• Study Start: March 1, 2015
• Primary Completion: October 31, 2016
• Study Completion: December 31, 2016
• Last Updated: May 15, 2017

Record last verified: 2017-05