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Respiratory Rehabilitation Exercises in Older Adults With Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Respiratory rehabilitation exercise training
Sponsored by
Chest Hospital, Ministry of Health and Welfare, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Acute exacerbation of chronic obstructive pulmonary disease, Older adults, Respiratory rehabilitation exercise

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. diagnosed with moderate COPD with moderate acute exacerbation
  2. over 65 years of age
  3. conscious clear
  4. with shortness of breath or dyspnea that was not caused by heart disease, pneumothorax, or pulmonary edema
  5. had received bronchodilator aerosol therapy or antibiotic treatment, but had not been treated with an antitussive

Exclusion Criteria:

  1. unstable vital signs
  2. blood oxygen concentration lower than 90%
  3. unstable psychological status, hemoptysis, pneumothorax, pulmonary edema, or using the respirator

Sites / Locations

  • Chest Hospital, Ministry of Health and Welfare

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

Respiratory rehabilitation exercise training 2 times/day, 10-30 minutes per session for 4 days.

Control group received usual care and health education.

Outcomes

Primary Outcome Measures

Change from baseline in dyspnea at 4th day
Measured by the Borg Rating of Perceived Exertion Scale.

Secondary Outcome Measures

Change from baseline in cough severity at 4th day
Measured by the visual analog scale.
Change from baseline in exercise tolerance at 4th day
Measured by the 6-minute walk distance
Change from baseline in sputum expectoration at 4th day
Assessed by recording the patients' feelings regarding sputum expectoration during the previous day.

Full Information

First Posted
December 15, 2014
Last Updated
December 30, 2014
Sponsor
Chest Hospital, Ministry of Health and Welfare, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT02329873
Brief Title
Respiratory Rehabilitation Exercises in Older Adults With Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Official Title
Efficacy of the Respiratory Rehabilitation Exercise Training Package in Hospitalized Elderly Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease: Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chest Hospital, Ministry of Health and Welfare, Taiwan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this randomized controlled trial was to evaluate the effects of a respiratory rehabilitation exercise training package on dyspnea, cough, exercise tolerance, and sputum expectoration of hospitalized elderly patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Using purposive sampling, 61 participants were recruited and randomly assigned to either the experimental group (n = 30) or the control group (n = 31). The experimental group participants received the respiratory rehabilitation exercise training twice a day and 10-30 minutes per session for four days. The control group participants received usual care and health education. Data were collected at baseline and at the end of the four-day intervention.
Detailed Description
The respiratory rehabilitation exercise training package included: (a) Disease awareness: The doctor explained the disease to patients and their families through the chest X-ray, (b) Sputum clearance treatments: Easily understood postural drainage cards were provided to the patients and families to assist with proper sputum clearance procedures, (c) Pursed lip breathing training: Devices were provided to the patients to ensure that the breathing exercises were completed properly, (d) Upper-limb exercise with breathing pranayama: Towels were provided to the patients to assist with upper-limb exercises properly, (e) Walking training with breathing pranayama: Legs were elevated while inhaling, and returned to the position while exhaling, and (f) Assign a pulmonary rehabilitation program coordinator: Coordinators were assigned to assist the patients in nutrition management and health education.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Acute exacerbation of chronic obstructive pulmonary disease, Older adults, Respiratory rehabilitation exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Respiratory rehabilitation exercise training 2 times/day, 10-30 minutes per session for 4 days.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group received usual care and health education.
Intervention Type
Behavioral
Intervention Name(s)
Respiratory rehabilitation exercise training
Other Intervention Name(s)
Respiratory rehabilitation
Intervention Description
The respiratory rehabilitation exercise training package was conducted twice a day and 10-30 minutes per session for 4 days: (a) disease awareness, (b) sputum clearance treatments, (c) pursed lip breathing training, (d) upper-limb exercise with breathing pranayama, (e) walking training with breathing pranayama, and (f) assign a pulmonary rehabilitation program coordinator.
Primary Outcome Measure Information:
Title
Change from baseline in dyspnea at 4th day
Description
Measured by the Borg Rating of Perceived Exertion Scale.
Time Frame
At baseline and at the 4th day of the study
Secondary Outcome Measure Information:
Title
Change from baseline in cough severity at 4th day
Description
Measured by the visual analog scale.
Time Frame
At baseline and at the 4th day of the study
Title
Change from baseline in exercise tolerance at 4th day
Description
Measured by the 6-minute walk distance
Time Frame
At baseline and at the 4th day of the study
Title
Change from baseline in sputum expectoration at 4th day
Description
Assessed by recording the patients' feelings regarding sputum expectoration during the previous day.
Time Frame
At baseline and at the 4th day of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: diagnosed with moderate COPD with moderate acute exacerbation over 65 years of age conscious clear with shortness of breath or dyspnea that was not caused by heart disease, pneumothorax, or pulmonary edema had received bronchodilator aerosol therapy or antibiotic treatment, but had not been treated with an antitussive Exclusion Criteria: unstable vital signs blood oxygen concentration lower than 90% unstable psychological status, hemoptysis, pneumothorax, pulmonary edema, or using the respirator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin-Yu Liao, MS
Organizational Affiliation
Chest Hospital, Ministry of Health and Welfare, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chest Hospital, Ministry of Health and Welfare
City
Kaohsiung
ZIP/Postal Code
71742
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
26345529
Citation
Liao LY, Chen KM, Chung WS, Chien JY. Efficacy of a respiratory rehabilitation exercise training package in hospitalized elderly patients with acute exacerbation of COPD: a randomized control trial. Int J Chron Obstruct Pulmon Dis. 2015 Aug 27;10:1703-9. doi: 10.2147/COPD.S90673. eCollection 2015.
Results Reference
derived

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Respiratory Rehabilitation Exercises in Older Adults With Acute Exacerbations of Chronic Obstructive Pulmonary Disease

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