Respiratory Regulation With Biofeedback in COPD

NCT03640260 | Terminated

• 1 other identifier: 180501
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• adherence - evaluated by diary record

  adherence of breathing and physical activity will be evaluated by diary record

  12 weeks

Study Arms (2)

experimental

EXPERIMENTAL

The experiment arm will get educational leaflets to pursed-lip with diaphragmatic breathing training and oximetry level evaluation.

Behavioral: breathing regulation with physical activity

controlled

NO INTERVENTION

Interventions

breathing regulation with physical activity BEHAVIORAL

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

experimental

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Diagnosed COPD, pulmonary spirometry test FEV1/FVC\<70% and FEV1\<80%.
• \. At least 20 years old and has communicative capacity.
• \. Can walk by self or assistive device prior hospitalization.

You may not qualify if:

• \. acute exacerbation attack or recurrent acute exacerbation and SpO2\< 90%.
• \. Can perform respiratory regulation correctly within exercising regularly.
• \. Know cancer.
• \. Comorbidity with sever pulmonary and cardiac disease.
• \. Diseases of musculoskeletal system.
• \. Psychotic or cognitive disorder that likely not be available to complete study procedures.
• \. the hearing-impaired or visually disabled.

Sponsors & Collaborators

• Changhua Christian Hospital: lead

Study Sites (1)

Changhua Christian Hospital

Changhua, Changhua County, 500, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nurse

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 21, 2018
• Study Start: September 5, 2018
• Primary Completion: December 31, 2018
• Study Completion: July 31, 2019
• Last Updated: February 26, 2020

Record last verified: 2020-02

Locations

TW (1)