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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02329873
Other study ID # ER-100-202
Secondary ID
Status Completed
Phase N/A
First received December 15, 2014
Last updated December 30, 2014
Start date November 2011
Est. completion date December 2012

Study information

Verified date December 2014
Source Chest Hospital, Ministry of Health and Welfare, Taiwan
Contact n/a
Is FDA regulated No
Health authority Taiwan: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Respiratory rehabilitation exercise training
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.

Locations

Country Name City State
Taiwan Chest Hospital, Ministry of Health and Welfare Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Chest Hospital, Ministry of Health and Welfare, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in dyspnea at 4th day Measured by the Borg Rating of Perceived Exertion Scale. At baseline and at the 4th day of the study No
Secondary Change from baseline in cough severity at 4th day Measured by the visual analog scale. At baseline and at the 4th day of the study No
Secondary Change from baseline in exercise tolerance at 4th day Measured by the 6-minute walk distance At baseline and at the 4th day of the study No
Secondary Change from baseline in sputum expectoration at 4th day Assessed by recording the patients' feelings regarding sputum expectoration during the previous day. At baseline and at the 4th day of the study No
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