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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02836912
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease Other: Exercise Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Pulmonary Rehabilitation Exercise in Home Care for the Non-invasive Ventilator-dependent Elderly With Chronic Obstructive Pulmonary Disease
Actual Study Start Date : December 4, 2015
Actual Primary Completion Date : July 26, 2016
Actual Study Completion Date : September 26, 2016

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: Regular education
Regular education for COPD, including percussion and posture drainage.
Experimental: Exercise
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.
 Other: Exercise
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


Outcome Measures
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Primary Outcome Measures :
  1. changed strength of respiratory muscles [ Time Frame: baseline , 8 weeks, 12 weeks ]
    inspforce(BUEHRINGER.USA)


Secondary Outcome Measures :
  1. changed lung function [ Time Frame: baseline , 8 weeks, 12 weeks ]
    spirometry

  2. changed value for quality of life [ Time Frame: baseline , 8 weeks, 12 weeks ]
    ST.George's Respiratory Questionnaire

  3. changed score of intensity of dyspnea [ Time Frame: baseline , 8 weeks, 12 weeks ]
    Borg dyspnoea scale

  4. time of weaning from ventilator [ Time Frame: baseline , 8 weeks, 12 weeks ]
    time of using ventilator data is directed recorded continually by chip of his/her ventilator during the study


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836912


Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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Principal Investigator: Miao-Ju Hsu, PHD 100,Shih-Chuan 1st Road,Kaohsiung,80708,Taiwan
More Information
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Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT02836912    
Other Study ID Numbers: KMUHIRB-E(I)-20150203
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
Rehabilitation
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases