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Respiratory Regulation With Biofeedback in COPD

Effects of Respiratory Regulation With Biofeedback in Patients With Chronic Obstructive Pulmonary Disease

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03640260
Acronym
RRBCOPD
Enrollment
5
Registered
2018-08-21
Start date
2018-09-05
Completion date
2019-07-31
Last updated
2020-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Brief 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 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.

Interventions

BEHAVIORALbreathing regulation with physical activity

The subjects will have education leaflets with breathing and oximetry level evaluation training.

Sponsors

Changhua Christian Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
adherence - evaluated by diary record12 weeksadherence of breathing and physical activity will be evaluated by diary record

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026