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
About this trial
This is an interventional treatment trial for Pulmonary Disease focused on measuring Rehabilitation
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
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
NCT ID
NCT02836912
First Posted
July 1, 2016
Last Updated
September 7, 2017
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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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