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Completed

NCT Number: NCT03153345

The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. functional vital capacity

    Time frame: 21 days

    functional vital capacity in percent (%)

  2. Forced expiratory volume

    Time frame: 21 days

    Forced expiratory volume in one second in percent (%)

  3. Peak flow

    Time frame: 21 days

    Peak flow in milliliter

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 15, 2017
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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