Pulmonary DiseaseNCT02836912
The Efficacy of Pulmonary Rehabilitation Exercise in Home Care for the Non-invasive Ventilator-dependent Elderly With COPD
A study testing Exercise in people with Pulmonary Disease, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 4 Dec 2015to 26 Sep 2016
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: The Efficacy of Pulmonary Rehabilitation Exercise in Home Care for the Non-invasive Ventilator-dependent Elderly With Chronic Obstructive Pulmonary Disease
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.
Read the 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.
- Conditions
- Pulmonary Disease
- Being tested
- Exercise
- Keywords
- Rehabilitation
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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 group | Role | What they receive |
|---|---|---|
| Regular education | No intervention | Regular education for COPD, including percussion and posture drainage. |
| Exercise | Experimental | 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
changed strength of respiratory muscles
inspforce(BUEHRINGER.USA)
Measured: baseline , 8 weeks, 12 weeks
Secondary outcomes (4)
changed lung function
spirometry
Measured: baseline , 8 weeks, 12 weeks
changed value for quality of life
ST.George's Respiratory Questionnaire
Measured: baseline , 8 weeks, 12 weeks
changed score of intensity of dyspnea
Borg dyspnoea scale
Measured: baseline , 8 weeks, 12 weeks
time of weaning from ventilator
time of using ventilator data is directed recorded continually by chip of his/her ventilator during the study
Measured: baseline , 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study start4 Dec 2015
- Primary completion26 Jul 2016
- Study completion26 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miao-Ju Hsu, PHD, Principal investigator, 100,Shih-Chuan 1st Road,Kaohsiung,80708,Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836912
- Sponsor's protocol ID
- KMUHIRB-E(I)-20150203
- Status last verified
- Sep 2017
- First submitted
- 1 Jul 2016
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Pulmonary Rehabilitation Exercise in Home Care for the Non-invasive Ventilator-dependent Elderly With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02836912
- Acronym / sponsor ID
- KMUHIRB-E(I)-20150203
- Conditions
- Pulmonary Disease
- Keywords
- Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 4 Dec 2015 (actual)
- Primary completion
- 26 Jul 2016 (actual)
- Study completion
- 26 Sep 2016 (actual)
- First posted
- 19 Jul 2016 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular education | No intervention | –Regular education for COPD, including percussion and posture drainage. |
| Exercise | Experimental | Other: ExerciseBesides 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| ExerciseBesides 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 | Other | Exercise |
Primary outcome
changed strength of respiratory muscles
Time frame: baseline , 8 weeks, 12 weeks
inspforce(BUEHRINGER.USA)
4 secondary outcomes
changed lung function
Time frame: baseline , 8 weeks, 12 weeks
changed value for quality of life
Time frame: baseline , 8 weeks, 12 weeks
changed score of intensity of dyspnea
Time frame: baseline , 8 weeks, 12 weeks
time of weaning from ventilator
Time frame: baseline , 8 weeks, 12 weeks
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 11 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Miao-Ju Hsu, PHD principal investigator
100,Shih-Chuan 1st Road,Kaohsiung,80708,Taiwan
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Pulmonary Disease, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
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 8 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 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
changed strength of respiratory muscles (time frame: baseline , 8 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2017.