NCT02329873

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 1, 2015

Completed
Last Updated

January 1, 2015

Status Verified

December 1, 2014

Enrollment Period

1.1 years

First QC Date

December 15, 2014

Last Update Submit

December 30, 2014

Conditions

Keywords

Acute exacerbation of chronic obstructive pulmonary diseaseOlder adultsRespiratory rehabilitation exercise

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Change from baseline in cough severity at 4th day

    At baseline and at the 4th day of the study

  • Change from baseline in exercise tolerance at 4th day

    At baseline and at the 4th day of the study

  • Change from baseline in sputum expectoration at 4th day

    At baseline and at the 4th day of the study

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Behavioral: Respiratory rehabilitation exercise training

Control group

NO INTERVENTION

Control group received usual care and health education.

Interventions

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.

Also known as: Respiratory rehabilitation
Experimental group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chest Hospital, Ministry of Health and Welfare

Kaohsiung City, 71742, Taiwan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lin-Yu Liao, MS

    Chest Hospital, Ministry of Health and Welfare, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Nurse

Study Record Dates

First Submitted

December 15, 2014

First Posted

January 1, 2015

Study Start

November 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 1, 2015

Record last verified: 2014-12

Locations