Effects of Respiratory Training on Respiratory and Functional Performance in Patients With Stroke

July 16, 2018 updated by: Chung-Hao Chuang, Chung Shan Medical University
The purpose of the research is to investigate the effects of respiratory training on respiratory and functional performance in patients with stroke.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Stroke ranks third in the global cause of death, behind cancer and coronary heart disease. Stroke is also the third largest cause of death in Taiwan in 2014. Stroke patients in the course of exercise are in addition to muscle weakness and reduced endurance, but usually also accompanied by respiratory damage. From past studies have shown that stroke patients whose respiratory function has significant change, such as decreased respiratory muscle strength, reduced respiratory movement of the affected hemithorax, declined in maximum breathing pressure and decreased amplitude of diaphragmatic movements on the paralyzed side. But whether respiratory training can improve respiratory and functional performance of stroke patients, because of the limited research results could not be confirmed.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Chun-Hou Wang, Professor.
  • Phone Number: 11015 +886-4-24730022
  • Email: wangcsmu@gmail.com

Study Locations

  • Taiwan
      • Taichung, Taiwan, 42010
        • Chung Shan Medical University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • first episode of unilateral stroke.
  • the definition of stroke was according to the World Health Organization (WHO) criteria (Hatano 1976), confirmed by computerized tomography (CT) or magnetic resonance imaging (MRI).
  • older than 20 years.
  • had maximum inspiratory pressure (MIP) values lower than 90% of those predicted and adjusted for age and sex.
  • facial palsy, which could not prevent proper labial occlusion.
  • ability to understand and follow simple verbal instructions.
  • no receptive aphasia.
  • not undergone thoracic or abdominal surgery.

Exclusion Criteria:

  • unable to perform the tests.
  • impaired level of consciousness and evidence of gross cognitive impairment.
  • excluded patients with comorbidities of respiratory system disease (e.g. chronic obstructive pulmonary disease, asthma, cystic fibrosis), or other diseases leading to the impairment of respiratory muscle (e.g. myasthenia gravis).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RT (respiratory training) group
Besides traditional rehabilitation therapy, subjects also receive 12-week respiratory training.
Other: respiratory training.
breathing exercise.
Sham Comparator: Control group
Besides traditional rehabilitation therapy, subjects receive 12-week sham training unrelated to respiratory function.
Other: sham training.
range of motion (ROM) exercise, stretching exercise or positioning exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diaphragm Thickness.
Time Frame: change from baseline diaphragm thickness at 12, 16, 24, 36 weeks.
In this study, the mid axillary lines between ribs 8 and 9 on both sides will be checked in a standing posture, then the chest wall is perpendicularly illuminated by a curved array 2-5 MHz transducer (Siemens Sololine G40) in an upright sitting position to observe the region between rib 8 and rib 9 in 2D images. The diaphragm thickness is measured as the distance between two parallel lines that appear bright in the middle of the pleura and in the middle peritoneum.
change from baseline diaphragm thickness at 12, 16, 24, 36 weeks.
Incidence of Pneumonia.
Time Frame: change from baseline incidence of pneumonia at 12, 16, 24, 36 weeks.
This study will observe the incidence of pneumonia of two groups in the 36-week research course.
change from baseline incidence of pneumonia at 12, 16, 24, 36 weeks.
Brunnstrom's motor recovery stages.
Time Frame: change from baseline Brunnstrom's stages at 12, 16, 24, 36 weeks.
The six sequential stages of motor recovery through which the hemiplegic upper and lower extremities progress used as a method for assessing recovery.
change from baseline Brunnstrom's stages at 12, 16, 24, 36 weeks.
Stroke Rehabilitation Assessment of Movement scale; STREAM.
Time Frame: change from baseline STREAM scores at 12, 16, 24, 36 weeks.
The STREAM scale is used to evaluate the recovery of voluntary movement and basic mobility following stroke. The scale consists of 30 items or test movements that are equally distributed among 3 subscales: upper-limb movements, lower-limb movements, and basic mobility items.
change from baseline STREAM scores at 12, 16, 24, 36 weeks.
Stroke-Specific Quality of Life scale; SS-QOL.
Time Frame: change from baseline SS-QOL scores at 12, 16, 24, 36 weeks.
The SS-QOL scale is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke. It consists of twelve commonly affected domains (energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity functioning, vision, and work/productivity) and 49 items.
change from baseline SS-QOL scores at 12, 16, 24, 36 weeks.
Stroke Impact Scale; SIS 3.0.
Time Frame: change from baseline SIS 3.0 scores at 12, 16, 24, 36 weeks.
The SIS 3.0 is a stroke-specific, self-report, health status measure. The scale includes 59 items and assesses 8 domains. It was designed to assess multidimensional stroke outcomes, including strength, hand function, activities of daily living/instrumental activities of daily living (ADL/IADL), mobility, communication, emotion, memory and thinking, and participation.
change from baseline SIS 3.0 scores at 12, 16, 24, 36 weeks.
Twelve-Minute Walk Test.
Time Frame: change from baseline Twelve-Minute Walk Test scores at 12, 16, 24, 36 weeks.
The distance (in meters) that a subject can walk within twelve minutes is evaluated.
change from baseline Twelve-Minute Walk Test scores at 12, 16, 24, 36 weeks.
Forced Vital Capacity (FVC) in liters.
Time Frame: change from baseline FVC at 12, 16, 24, 36 weeks.
Resting spirometry of FVC will be performed on a spirometer.
change from baseline FVC at 12, 16, 24, 36 weeks.
Vital Capacity (VC) in liters.
Time Frame: change from baseline VC at 12, 16, 24, 36 weeks.
Resting spirometry of VC will be performed on a spirometer.
change from baseline VC at 12, 16, 24, 36 weeks.
Forced Expiratory Volume at 1 second (FEV1) in liters.
Time Frame: change from baseline FEV1 at 12, 16, 24, 36 weeks.
Resting spirometry of FEV1 will be performed on a spirometer.
change from baseline FEV1 at 12, 16, 24, 36 weeks.
Ratio of FEV1 to FVC (FEV1/FVC).
Time Frame: change from baseline FEV1/FVC ratio at 12, 16, 24, 36 weeks.
Resting spirometry of FEV1/FVC ratio will be performed on a spirometer.
change from baseline FEV1/FVC ratio at 12, 16, 24, 36 weeks.
Forced Expiratory Flow rate 25-75% (FEF 25-75%) in liters per minute.
Time Frame: change from baseline FEF 25-75% at 12, 16, 24, 36 weeks.
Resting spirometry of FEF 25-75% will be performed on a spirometer.
change from baseline FEF 25-75% at 12, 16, 24, 36 weeks.
Peak Expiratory Flow Rate (PEFR) in liters per minute.
Time Frame: change from baseline PEFR at 12, 16, 24, 36 weeks.
Resting spirometry of PEFR will be performed on a spirometer.
change from baseline PEFR at 12, 16, 24, 36 weeks.
Maximum Inspiratory Pressure (PImax) in centimeters of water pressure (cmH2O).
Time Frame: change from baseline PImax at 12, 16, 24, 36 weeks.
Resting spirometry of PImax will be performed on a spirometer.
change from baseline PImax at 12, 16, 24, 36 weeks.
Maximum Expiratory Pressures (PEmax) in centimeters of water pressure (cmH2O).
Time Frame: change from baseline PEmax at 12, 16, 24, 36 weeks.
Resting spirometry of PEmax will be performed on a spirometer.
change from baseline PEmax at 12, 16, 24, 36 weeks.
Maximum Voluntary Ventilation (MVV) in liters per minute.
Time Frame: change from baseline MVV at 12, 16, 24, 36 weeks.
Resting spirometry of MVV will be performed on a spirometer.
change from baseline MVV at 12, 16, 24, 36 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Investigators

  • Principal Investigator: Chung-Hao Chuang, PhD study., Chung Shan Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2018

Primary Completion (Anticipated)

June 30, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

March 18, 2016

First Submitted That Met QC Criteria

March 29, 2016

First Posted (Estimate)

April 4, 2016

Study Record Updates

Last Update Posted (Actual)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSH-2016-A-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on respiratory training.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe