- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03640260
Respiratory Regulation With Biofeedback in COPD (RRBCOPD)
Effects of Respiratory Regulation With Biofeedback in Patients With Chronic Obstructive Pulmonary Disease
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Changhua County
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Changhua, Changhua County, Taiwan, 500
- Changhua Christian Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental
The experiment arm will get educational leaflets to pursed-lip with diaphragmatic breathing training and oximetry level evaluation.
|
The subjects will have education leaflets with breathing and oximetry level evaluation training.
|
No Intervention: controlled
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adherence - evaluated by diary record
Time Frame: 12 weeks
|
adherence of breathing and physical activity will be evaluated by diary record
|
12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 180501
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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