Chronic Obstructive Pulmonary Disease (COPD)NCT02329873
Respiratory Rehabilitation Exercises in Older Adults With Acute Exacerbations of Chronic Obstructive Pulmonary Disease
A study testing Respiratory rehabilitation exercise training in people with Chronic Obstructive Pulmonary Disease (COPD), run by Chest Hospital, Ministry of Health and Welfare, Taiwan at 1 site in Taiwan.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Respiratory rehabilitation exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- unstable vital signs
- blood oxygen concentration lower than 90%
- unstable psychological status, hemoptysis, pneumothorax, pulmonary edema, or using the respirator
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chest Hospital, Ministry of Health and Welfare
Kaohsiung City, 71742
About this study
Official title: 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.
Read the 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.
- Being tested
- Respiratory rehabilitation exercise training
- Keywords
- Acute exacerbation of chronic obstructive pulmonary disease, Older adults, Respiratory rehabilitation exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory rehabilitation exercise trainingBehavioural
Also called Respiratory rehabilitation
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Respiratory rehabilitation exercise training 2 times/day, 10-30 minutes per session for 4 days. Receives: Behavioral: Respiratory rehabilitation exercise training |
| Control group | No intervention | Control group received usual care and health education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in dyspnea at 4th day
Measured by the Borg Rating of Perceived Exertion Scale.
Measured: At baseline and at the 4th day of the study
Secondary outcomes (3)
Change from baseline in cough severity at 4th day
Measured by the visual analog scale.
Measured: At baseline and at the 4th day of the study
Change from baseline in exercise tolerance at 4th day
Measured by the 6-minute walk distance
Measured: At baseline and at the 4th day of the study
Change from baseline in sputum expectoration at 4th day
Assessed by recording the patients' feelings regarding sputum expectoration during the previous day.
Measured: At baseline and at the 4th day of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chest Hospital, Ministry of Health and Welfare, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lin-Yu Liao, Chest Hospital, Ministry of Health and Welfare, Taiwan
- Investigators
- Lin-Yu Liao, MS, Principal investigator, Chest Hospital, Ministry of Health and Welfare, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329873
- Sponsor's protocol ID
- ER-100-202
- Status last verified
- Dec 2014
- First submitted
- 15 Dec 2014
- Last updated
- 1 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Liao LY, Chen KM, Chung WS, Chien JY. Efficacy of a respiratory rehabilitation exercise training package in hospitalized elderly patients with acute exacerbation of COPD: a randomized control trial. Int J Chron Obstruct Pulmon Dis. 2015 Aug 27;10:1703-9. doi: 10.2147/COPD.S90673. eCollection 2015.
PubMed 26345529
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Respiratory Rehabilitation Exercise Training Package in Hospitalized Elderly Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02329873
- Acronym / sponsor ID
- ER-100-202
- Keywords
- Acute exacerbation of chronic obstructive pulmonary disease, Older adults, Respiratory rehabilitation exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Chest Hospital, Ministry of Health and Welfare, TaiwanOther government
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Respiratory rehabilitation exercise trainingRespiratory rehabilitation exercise training 2 times/day, 10-30 minutes per session for 4 days. |
| Control group | No intervention | –Control group received usual care and health education. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- unstable vital signs
- blood oxygen concentration lower than 90%
- unstable psychological status, hemoptysis, pneumothorax, pulmonary edema, or using the respirator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory rehabilitation exercise trainingAlso: Respiratory rehabilitationThe 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. | Behavioural | Experimental group |
Primary outcome
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.
3 secondary outcomes
Change from baseline in cough severity at 4th day
Time frame: At baseline and at the 4th day of the study
Change from baseline in exercise tolerance at 4th day
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2015.
- Derived from this study: PubMed 26345529Liao LY, Chen KM, Chung WS, Chien JY. Efficacy of a respiratory rehabilitation exercise training package in hospitalized elderly patients with acute exacerbation of COPD: a randomized control trial. Int J Chron Obstruct Pulmon Dis. 2015 Aug 27;10:1703-9. doi: 10.2147/COPD.S90673. eCollection 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin-Yu Liao, MS principal investigator
Chest Hospital, Ministry of Health and Welfare, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory rehabilitation exercise training in people with Chronic Obstructive Pulmonary Disease (COPD), run by Chest Hospital, Ministry of Health and Welfare, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in dyspnea at 4th day (time frame: At baseline and at the 4th day of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02329873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2015.