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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

Tracking Information
First Submitted Date  ICMJE July 1, 2016
First Posted Date  ICMJE July 19, 2016
Last Update Posted Date September 11, 2017
Actual Study Start Date  ICMJE December 4, 2015
Actual Primary Completion Date July 26, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
changed strength of respiratory muscles [ Time Frame: baseline , 8 weeks, 12 weeks ]
inspforce(BUEHRINGER.USA)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
  • changed lung function [ Time Frame: baseline , 8 weeks, 12 weeks ]
    spirometry
  • changed value for quality of life [ Time Frame: baseline , 8 weeks, 12 weeks ]
    ST.George's Respiratory Questionnaire
  • changed score of intensity of dyspnea [ Time Frame: baseline , 8 weeks, 12 weeks ]
    Borg dyspnoea scale
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Pulmonary Rehabilitation Exercise in Home Care for the Non-invasive Ventilator-dependent Elderly With COPD
Official Title  ICMJE The Efficacy of Pulmonary Rehabilitation Exercise in Home Care for the Non-invasive Ventilator-dependent Elderly With Chronic Obstructive Pulmonary Disease
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Disease
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Other: Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2017)
28
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2016)
60
Actual Study Completion Date  ICMJE September 26, 2016
Actual Primary Completion Date July 26, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02836912
Other Study ID Numbers  ICMJE KMUHIRB-E(I)-20150203
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kaohsiung Medical University Chung-Ho Memorial Hospital
Study Sponsor  ICMJE Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Miao-Ju Hsu, PHD 100,Shih-Chuan 1st Road,Kaohsiung,80708,Taiwan
PRS Account Kaohsiung Medical University Chung-Ho Memorial Hospital
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP