The Efficacy of Pulmonary Rehabilitation Exercise in Home Care for the Non-invasive Ventilator-dependent Elderly With COPD
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ClinicalTrials.gov Identifier: NCT02836912 |
Recruitment Status :
Completed
First Posted : July 19, 2016
Last Update Posted : September 11, 2017
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Condition or disease | Intervention/treatment | Phase |
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Pulmonary Disease | Other: Exercise | Not Applicable |
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 |

Arm | Intervention/treatment |
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No Intervention: Regular education
Regular education for COPD, including percussion and posture drainage.
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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.
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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 |
- changed strength of respiratory muscles [ Time Frame: baseline , 8 weeks, 12 weeks ]inspforce(BUEHRINGER.USA)
- 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

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

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
Principal Investigator: | Miao-Ju Hsu, PHD | 100,Shih-Chuan 1st Road,Kaohsiung,80708,Taiwan |
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 |
Rehabilitation |
Lung Diseases Respiratory Tract Diseases |