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The Efficacy of Pulmonary Rehabilitation Exercise in Home Care for the Non-invasive Ventilator-dependent Elderly With COPD

Primary Purpose

Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease focused on measuring Rehabilitation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. age > 65 y/o, and is diagnosed with COPD;
  2. is non-invasive ventilator-dependent in home care;
  3. is stable evaluated by a doctor;
  4. is conscious clear and can perform the exercise (upper, lower extremity, and respiratory muscle training);
  5. do not accept exercise training as (4)-mentioned currently

Exclusion Criteria:

  1. conscious is not clear enough to perform the exercise training;
  2. cannot leave his/her bed independently;
  3. cannot wean a ventilator and need to use for 24 hours;
  4. severe heart disease (eg. acute myocardial infarction, severe arrhythmia);
  5. Oxygen saturation (SPO2) lower than 90% during oxygen therapy
  6. fever or acute infections
  7. reject to sign consent form
  8. age < 20 y/o

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Regular education

    Exercise

    Arm Description

    Regular education for COPD, including percussion and posture drainage.

    Besides the same information for the education group, exercise of upper extremity without loading, exercise of lower extremity, and training of respiratory muscles are used for the exercise group.

    Outcomes

    Primary Outcome Measures

    changed strength of respiratory muscles
    inspforce(BUEHRINGER.USA)

    Secondary Outcome Measures

    changed lung function
    spirometry
    changed value for quality of life
    ST.George's Respiratory Questionnaire
    changed score of intensity of dyspnea
    Borg dyspnoea scale
    time of weaning from ventilator
    time of using ventilator data is directed recorded continually by chip of his/her ventilator during the study

    Full Information

    First Posted
    July 1, 2016
    Last Updated
    September 7, 2017
    Sponsor
    Kaohsiung Medical University Chung-Ho Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02836912
    Brief Title
    The Efficacy of Pulmonary Rehabilitation Exercise in Home Care for the Non-invasive Ventilator-dependent Elderly With COPD
    Official Title
    The Efficacy of Pulmonary Rehabilitation Exercise in Home Care for the Non-invasive Ventilator-dependent Elderly With Chronic Obstructive Pulmonary Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 4, 2015 (Actual)
    Primary Completion Date
    July 26, 2016 (Actual)
    Study Completion Date
    September 26, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kaohsiung Medical University Chung-Ho Memorial Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Pulmonary rehabilitation exercise is beneficial for individuals with chronic obstructive pulmonary disease (COPD). However, merely 30% patients know how to do the exercise correctly. Therefore, it is worthy to investigate the applications in clinical practice. In addition, there are no relative research in Taiwan to see effects of an 8-week pulmonary rehabilitation exercise in home care for the non-invasive ventilator-dependent elderly with COPD.
    Detailed Description
    According to estimation of the world health organization (WHO), chronic obstructive pulmonary disease (COPD) would become the third major cause of death. Moreover, the lung recovery exercise is proven beneficial for mild, moderate, or severe COPD by the guideline of GOLD. However, research in Taiwan focused on follow-up medical status for mild or moderate COPD in clinics, or weaning of severe COPD in intensive care unit (ICU). There was no relative research investigating non-invasive ventilator-dependent elderly with COPD on home care. Therefore, this study would explore effects of pulmonary rehabilitation exercise for this group. The pulmonary rehabilitation exercise program in this study is divided into two stages in the experimental group. The first four weeks, 10 minutes for each training (upper extremity without loading, exercise of lower extremity, and respiratory muscles), and totally 30 minutes is required. Consequent four weeks, 15 minutes for upper extremity without loading, 15 minutes for exercise of lower extremity, and 10 minutes for training of respiratory muscles, and totally 40 minutes is scheduled.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Disease
    Keywords
    Rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Regular education
    Arm Type
    No Intervention
    Arm Description
    Regular education for COPD, including percussion and posture drainage.
    Arm Title
    Exercise
    Arm Type
    Experimental
    Arm Description
    Besides the same information for the education group, exercise of upper extremity without loading, exercise of lower extremity, and training of respiratory muscles are used for the exercise group.
    Intervention Type
    Other
    Intervention Name(s)
    Exercise
    Intervention Description
    Besides the same information for the education group, exercise of upper extremity without loading, exercise of lower extremity, and training of respiratory muscles are used for the exercise group
    Primary Outcome Measure Information:
    Title
    changed strength of respiratory muscles
    Description
    inspforce(BUEHRINGER.USA)
    Time Frame
    baseline , 8 weeks, 12 weeks
    Secondary Outcome Measure Information:
    Title
    changed lung function
    Description
    spirometry
    Time Frame
    baseline , 8 weeks, 12 weeks
    Title
    changed value for quality of life
    Description
    ST.George's Respiratory Questionnaire
    Time Frame
    baseline , 8 weeks, 12 weeks
    Title
    changed score of intensity of dyspnea
    Description
    Borg dyspnoea scale
    Time Frame
    baseline , 8 weeks, 12 weeks
    Title
    time of weaning from ventilator
    Description
    time of using ventilator data is directed recorded continually by chip of his/her ventilator during the study
    Time Frame
    baseline , 8 weeks, 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age > 65 y/o, and is diagnosed with COPD; is non-invasive ventilator-dependent in home care; is stable evaluated by a doctor; is conscious clear and can perform the exercise (upper, lower extremity, and respiratory muscle training); do not accept exercise training as (4)-mentioned currently Exclusion Criteria: conscious is not clear enough to perform the exercise training; cannot leave his/her bed independently; cannot wean a ventilator and need to use for 24 hours; severe heart disease (eg. acute myocardial infarction, severe arrhythmia); Oxygen saturation (SPO2) lower than 90% during oxygen therapy fever or acute infections reject to sign consent form age < 20 y/o
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Miao-Ju Hsu, PHD
    Organizational Affiliation
    100,Shih-Chuan 1st Road,Kaohsiung,80708,Taiwan
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Efficacy of Pulmonary Rehabilitation Exercise in Home Care for the Non-invasive Ventilator-dependent Elderly With COPD

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