The Efficacy of Pulmonary Rehabilitation Exercise in Home Care for the Non-invasive Ventilator-dependent Elderly With COPD

Not Applicable

Completed

• Conditions: Pulmonary Disease
• Interventions: Other: Exercise

• Registration Number: NCT02836912
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief 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. 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 Timeline

• Study Start: 2015-12-04
• Study First Submitted: 2016-07-01
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-19
• Primary Completion: 2016-07-26
• Study Completion: 2016-09-26
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-07
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. age > 65 y/o, and is diagnosed with COPD;
2. is non-invasive ventilator-dependent in home care;
3. is stable evaluated by a doctor;
4. is conscious clear and can perform the exercise (upper, lower extremity, and respiratory muscle training);
5. do not accept exercise training as (4)-mentioned currently

Exclusion Criteria

1. conscious is not clear enough to perform the exercise training;
2. cannot leave his/her bed independently;
3. cannot wean a ventilator and need to use for 24 hours;
4. severe heart disease (eg. acute myocardial infarction, severe arrhythmia);
5. Oxygen saturation (SPO2) lower than 90% during oxygen therapy
6. fever or acute infections
7. reject to sign consent form
8. age < 20 y/o

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	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.

Primary Outcome Measures

Name	Time	Method
changed strength of respiratory muscles	baseline , 8 weeks, 12 weeks	inspforce(BUEHRINGER.USA)

Secondary Outcome Measures

Name	Time	Method
changed lung function	baseline , 8 weeks, 12 weeks	spirometry
changed score of intensity of dyspnea	baseline , 8 weeks, 12 weeks	Borg dyspnoea scale
time of weaning from ventilator	baseline , 8 weeks, 12 weeks	time of using ventilator data is directed recorded continually by chip of his/her ventilator during the study
changed value for quality of life	baseline , 8 weeks, 12 weeks	ST.George's Respiratory Questionnaire