- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02329873
Respiratory Rehabilitation Exercises in Older Adults With Acute Exacerbations of Chronic Obstructive Pulmonary Disease
December 30, 2014 updated by: Lin-Yu Liao, Chest Hospital, Ministry of Health and Welfare, Taiwan
Efficacy of the Respiratory Rehabilitation Exercise Training Package in Hospitalized Elderly Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease: Randomized Control Trial
The purpose of this randomized controlled trial was to evaluate the effects of a respiratory rehabilitation exercise training package on dyspnea, cough, exercise tolerance, and sputum expectoration of hospitalized elderly patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD).
Using purposive sampling, 61 participants were recruited and randomly assigned to either the experimental group (n = 30) or the control group (n = 31).
The experimental group participants received the respiratory rehabilitation exercise training twice a day and 10-30 minutes per session for four days.
The control group participants received usual care and health education.
Data were collected at baseline and at the end of the four-day intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The respiratory rehabilitation exercise training package included: (a) Disease awareness: The doctor explained the disease to patients and their families through the chest X-ray, (b) Sputum clearance treatments: Easily understood postural drainage cards were provided to the patients and families to assist with proper sputum clearance procedures, (c) Pursed lip breathing training: Devices were provided to the patients to ensure that the breathing exercises were completed properly, (d) Upper-limb exercise with breathing pranayama: Towels were provided to the patients to assist with upper-limb exercises properly, (e) Walking training with breathing pranayama: Legs were elevated while inhaling, and returned to the position while exhaling, and (f) Assign a pulmonary rehabilitation program coordinator: Coordinators were assigned to assist the patients in nutrition management and health education.
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kaohsiung, Taiwan, 71742
- Chest Hospital, Ministry of Health and Welfare
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- diagnosed with moderate COPD with moderate acute exacerbation
- over 65 years of age
- conscious clear
- with shortness of breath or dyspnea that was not caused by heart disease, pneumothorax, or pulmonary edema
- had received bronchodilator aerosol therapy or antibiotic treatment, but had not been treated with an antitussive
Exclusion Criteria:
- unstable vital signs
- blood oxygen concentration lower than 90%
- unstable psychological status, hemoptysis, pneumothorax, pulmonary edema, or using the respirator
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
Respiratory rehabilitation exercise training 2 times/day, 10-30 minutes per session for 4 days.
|
The respiratory rehabilitation exercise training package was conducted twice a day and 10-30 minutes per session for 4 days: (a) disease awareness, (b) sputum clearance treatments, (c) pursed lip breathing training, (d) upper-limb exercise with breathing pranayama, (e) walking training with breathing pranayama, and (f) assign a pulmonary rehabilitation program coordinator.
Other Names:
|
No Intervention: Control group
Control group received usual care and health education.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in dyspnea at 4th day
Time Frame: At baseline and at the 4th day of the study
|
Measured by the Borg Rating of Perceived Exertion Scale.
|
At baseline and at the 4th day of the study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in cough severity at 4th day
Time Frame: At baseline and at the 4th day of the study
|
Measured by the visual analog scale.
|
At baseline and at the 4th day of the study
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Change from baseline in exercise tolerance at 4th day
Time Frame: At baseline and at the 4th day of the study
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Measured by the 6-minute walk distance
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At baseline and at the 4th day of the study
|
Change from baseline in sputum expectoration at 4th day
Time Frame: At baseline and at the 4th day of the study
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Assessed by recording the patients' feelings regarding sputum expectoration during the previous day.
|
At baseline and at the 4th day of the study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lin-Yu Liao, MS, Chest Hospital, Ministry of Health and Welfare, Taiwan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
December 15, 2014
First Submitted That Met QC Criteria
December 30, 2014
First Posted (Estimate)
January 1, 2015
Study Record Updates
Last Update Posted (Estimate)
January 1, 2015
Last Update Submitted That Met QC Criteria
December 30, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ER-100-202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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