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

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease
• Intervention / Treatment: Other: Exercise

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Regular education; Regular education for COPD, including percussion and posture drainage.
Experimental: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changed strength of respiratory muscles	inspforce(BUEHRINGER.USA)	baseline , 8 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changed lung function	spirometry	baseline , 8 weeks, 12 weeks
changed value for quality of life	ST.George's Respiratory Questionnaire	baseline , 8 weeks, 12 weeks
changed score of intensity of dyspnea	Borg dyspnoea scale	baseline , 8 weeks, 12 weeks
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

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Principal Investigator: Miao-Ju Hsu, PHD, 100,Shih-Chuan 1st Road,Kaohsiung,80708,Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2015
• Primary Completion (Actual): July 26, 2016
• Study Completion (Actual): September 26, 2016

Study Registration Dates

• First Submitted: July 1, 2016
• First Submitted That Met QC Criteria: July 18, 2016
• First Posted (Estimate): July 19, 2016

Study Record Updates

• Last Update Posted (Actual): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 7, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Rehabilitation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: KMUHIRB-E(I)-20150203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO