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

NCT02836912 | Completed DMC

• 1 other identifier: KMUHIRB-E(I)-20150203
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Disease

Keywords

Rehabilitation

Outcome Measures

Primary Outcomes (1)

• changed strength of respiratory muscles

  inspforce(BUEHRINGER.USA)

  baseline , 8 weeks, 12 weeks

Secondary Outcomes (4)

• changed lung function

  baseline , 8 weeks, 12 weeks

• changed value for quality of life

  baseline , 8 weeks, 12 weeks

• changed score of intensity of dyspnea

  baseline , 8 weeks, 12 weeks

• time of weaning from ventilator

  baseline , 8 weeks, 12 weeks

Study Arms (2)

Regular education

NO INTERVENTION

Regular education for COPD, including percussion and posture drainage.

Exercise

EXPERIMENTAL

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

Interventions

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

Exercise

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

MeSH Terms

Conditions

Lung Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Miao-Ju Hsu, PHD

  100,Shih-Chuan 1st Road,Kaohsiung,80708,Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2016
• First Posted: July 19, 2016
• Study Start: December 4, 2015
• Primary Completion: July 26, 2016
• Study Completion: September 26, 2016
• Last Updated: September 11, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share