Clinical trial NCT02836912: The Efficacy of Pulmonary Rehabilitation Exercise in Home Care for the Non-invasive Ventilator-dependent Elderly With COPD
Official title: The Efficacy of Pulmonary Rehabilitation Exercise in Home Care for the Non-invasive Ventilator-dependent Elderly With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease
Keywords: Rehabilitation
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2016-07-19
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: changed strength of respiratory muscles
timeFrame: baseline , 8 weeks, 12 weeks
Secondary outcomes:
measure: changed lung function
timeFrame: baseline , 8 weeks, 12 weeks
measure: changed value for quality of life
timeFrame: baseline , 8 weeks, 12 weeks
measure: changed score of intensity of dyspnea
timeFrame: baseline , 8 weeks, 12 weeks
measure: time of weaning from ventilator
timeFrame: baseline , 8 weeks, 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: 100,Shih-Chuan 1st Road,Kaohsiung,80708,Taiwan
name: Miao-Ju Hsu, PHD
role: PRINCIPAL_INVESTIGATOR
References: