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

Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836912
• Other study ID #: KMUHIRB-E(I)-20150203
• Status: Completed
• Phase: N/A
• First received: July 1, 2016
• Last updated: September 7, 2017
• Start date: December 4, 2015
• Est. completion date: September 26, 2016

Study information

• Verified date: September 2017
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 26, 2016
• Est. primary completion date: July 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease

Intervention

Other:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changed strength of respiratory muscles	inspforce(BUEHRINGER.USA)	baseline , 8 weeks, 12 weeks
Secondary	changed lung function	spirometry	baseline , 8 weeks, 12 weeks
Secondary	changed value for quality of life	ST.George's Respiratory Questionnaire	baseline , 8 weeks, 12 weeks
Secondary	changed score of intensity of dyspnea	Borg dyspnoea scale	baseline , 8 weeks, 12 weeks
Secondary	time of weaning from ventilator	time of using ventilator data is directed recorded continually by chip of his/her ventilator during the study	baseline , 8 weeks, 12 weeks