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Completed

NCT Number: NCT02836912

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Exercise

Other

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 outcomes

  1. changed strength of respiratory muscles

    Time frame: baseline , 8 weeks, 12 weeks

    inspforce(BUEHRINGER.USA)

Secondary outcomes

  1. changed lung function

    Time frame: baseline , 8 weeks, 12 weeks

    spirometry

  2. changed value for quality of life

    Time frame: baseline , 8 weeks, 12 weeks

    ST.George's Respiratory Questionnaire

  3. changed score of intensity of dyspnea

    Time frame: baseline , 8 weeks, 12 weeks

    Borg dyspnoea scale

  4. time of weaning from ventilator

    Time frame: baseline , 8 weeks, 12 weeks

    time of using ventilator data is directed recorded continually by chip of his/her ventilator during the study

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 19, 2016
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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