COPDRRBCOPDNCT03640260
Respiratory Regulation With Biofeedback in COPD
A study testing breathing regulation with physical activity in people with COPD, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
Dyspnea is the main reason that patient with chronic obstructive pulmonary disease(COPD) to sedentary. It's a vicious circle of deteriorating lung function. The heart rate various(HRV)biofeedback with respiratory regulation training had been reported to reduce dyspnea and improve regulatory physical activities in… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- COPD
- What is being tested?
- breathing regulation with physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Sep 2018to 31 Jul 2019
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Diagnosed COPD, pulmonary spirometry test FEV1/FVC<70% and FEV1<80%.
- 2. At least 20 years old and has communicative capacity.
- 3. Can walk by self or assistive device prior hospitalization.
Who cannot join
- 1. acute exacerbation attack or recurrent acute exacerbation and SpO2< 90%.
- 2. Can perform respiratory regulation correctly within exercising regularly.
- 3. Know cancer.
- 4. Comorbidity with sever pulmonary and cardiac disease.
- 5. Diseases of musculoskeletal system.
- 6. Psychotic or cognitive disorder that likely not be available to complete study procedures.
- 7. the hearing-impaired or visually disabled.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Respiratory Regulation With Biofeedback in Patients With Chronic Obstructive Pulmonary Disease
Dyspnea is the main reason that patient with chronic obstructive pulmonary disease(COPD) to sedentary. It's a vicious circle of deteriorating lung function. The heart rate various(HRV)biofeedback with respiratory regulation training had been reported to reduce dyspnea and improve regulatory physical activities in COPD. However, HRV is not available with patients in communities persistently, the arm of this study is to explore the effect of the pulse oximeter biofeedback with respiratory regulation training to improve physical activities in COPD. A 2-group, randomized design study, the subjects are GOLD stage II-IV COPD from a medical center hospital of the middle of Taiwan. The experiment cases will be taught the skills of evaluating oximeter data and performing correct pursed-lip with diaphragmatic breathing. All experiment and controlled patients have to fill out the demographic form, the modified British Medical Research Council (mMRC), the international physical Activity questionnaire- short form(IPAQ-SF), exercise self-regulation efficacy scale (Ex-SRES), COPD assessment test (CAT), and physical activity \& respiratory training diary in pre-intervention and 12 weeks later. The collective data will analyze with SPSS 22.0.
Read the detailed description
Before subjects begin participation in any study-specific procedures, the investigators get institutional review board approval of the protocol, informed consent form, questionnaires and all subject information. A subject is considered enrolled when the investigator decides that the subject has met all eligibility criteria. All subjects must personally sign and date the IRB approved ICF before commencement of study-specific procedures. Each subject who enters the screening period for the study will receive a unique subject identification number before any study-related activities are performed. This number will be used to identify the subject throughout the study.
116 subjects will spend 20~30 minutes to fill out based demographic forms, mMRC, CAT, IPAQ, Ex-SRES and simple emotion questionnaires, then be randomized by sealed envelope to 1 of 2 arms. Under routine care, the experiment arm will get educational leaflets to pursed-lip with diaphragmatic breathing training and oximetry level evaluation. The controlled arm also has education leaflets but without breathing and oximetry level evaluation training. They be required to record respiratory regulation and physical activity diary while home care period up to first following out-patient department (about 12 weeks later). In the home care period, there are three times phone monitors to remind keep recording diary at first, forth and eighth week. Finally, mMRC, CAT, IPAQ and Ex-SRES will be finished again when first follow visit.
- Conditions
- COPD
- Being tested
- breathing regulation with physical activity
- 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.
breathing regulation with physical activityBehavioural
The subjects will have education leaflets with breathing and oximetry level evaluation training.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | The experiment arm will get educational leaflets to pursed-lip with diaphragmatic breathing training and oximetry level evaluation. Receives: Behavioral: breathing regulation with physical activity |
| controlled | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
adherence - evaluated by diary record
adherence of breathing and physical activity will be evaluated by diary record
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start5 Sep 2018
- Primary completion31 Dec 2018
- Study completion31 Jul 2019
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, I Ting Hsiao, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640260
- Sponsor's protocol ID
- 180501
- Acronym
- RRBCOPD
- Status last verified
- Feb 2020
- First submitted
- 14 Aug 2018
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Respiratory Regulation With Biofeedback in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03640260
- Acronym / sponsor ID
- RRBCOPD / 180501
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 21 Aug 2018 (actual)
- 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.
Dyspnea is the main reason that patient with chronic obstructive pulmonary disease(COPD) to sedentary. It's a vicious circle of deteriorating lung function. The heart rate various(HRV)biofeedback with respiratory regulation training had been reported to reduce dyspnea and improve regulatory physical activities in COPD. However, HRV is not available with patients in communities persistently, the arm of this study is to explore the effect of the pulse oximeter biofeedback with respiratory regulation training to improve physical activities in COPD. A 2-group, randomized design study, the subjects are GOLD stage II-IV COPD from a medical center hospital of the middle of Taiwan. The experiment cases will be taught the skills of evaluating oximeter data and performing correct pursed-lip with diaphragmatic breathing. All experiment and controlled patients have to fill out the demographic form, the modified British Medical Research Council (mMRC), the international physical Activity questionnaire- short form(IPAQ-SF), exercise self-regulation efficacy scale (Ex-SRES), COPD assessment test (CAT), and physical activity \& respiratory training diary in pre-intervention and 12 weeks later. The collective data will analyze with SPSS 22.0.
Detailed description
Before subjects begin participation in any study-specific procedures, the investigators get institutional review board approval of the protocol, informed consent form, questionnaires and all subject information. A subject is considered enrolled when the investigator decides that the subject has met all eligibility criteria. All subjects must personally sign and date the IRB approved ICF before commencement of study-specific procedures. Each subject who enters the screening period for the study will receive a unique subject identification number before any study-related activities are performed. This number will be used to identify the subject throughout the study.
116 subjects will spend 20~30 minutes to fill out based demographic forms, mMRC, CAT, IPAQ, Ex-SRES and simple emotion questionnaires, then be randomized by sealed envelope to 1 of 2 arms. Under routine care, the experiment arm will get educational leaflets to pursed-lip with diaphragmatic breathing training and oximetry level evaluation. The controlled arm also has education leaflets but without breathing and oximetry level evaluation training. They be required to record respiratory regulation and physical activity diary while home care period up to first following out-patient department (about 12 weeks later). In the home care period, there are three times phone monitors to remind keep recording diary at first, forth and eighth week. Finally, mMRC, CAT, IPAQ and Ex-SRES will be finished again when first follow visit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Behavioral: breathing regulation with physical activityThe experiment arm will get educational leaflets to pursed-lip with diaphragmatic breathing training and oximetry level evaluation. |
| controlled | No intervention | – |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Diagnosed COPD, pulmonary spirometry test FEV1/FVC<70% and FEV1<80%.
- 2. At least 20 years old and has communicative capacity.
- 3. Can walk by self or assistive device prior hospitalization.
Key exclusion criteria (7 listed)
- 1. acute exacerbation attack or recurrent acute exacerbation and SpO2< 90%.
- 2. Can perform respiratory regulation correctly within exercising regularly.
- 3. Know cancer.
- 4. Comorbidity with sever pulmonary and cardiac disease.
- 5. Diseases of musculoskeletal system.
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 |
|---|---|---|
| breathing regulation with physical activityThe subjects will have education leaflets with breathing and oximetry level evaluation training. | Behavioural | experimental |
Primary outcome
adherence - evaluated by diary record
Time frame: 12 weeks
adherence of breathing and physical activity will be evaluated by diary record
Results and safety
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breathing regulation with physical activity in people with COPD, run by Changhua Christian Hospital 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 26 Feb 2020. 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 was stopped early (reason given: low enrollment). Results are not available in the source record.
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?
adherence - evaluated by diary record (time frame: 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 26 Feb 2020.