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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03611127
Other study ID # ESR_15_11404_SHOUKRI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2016
Est. completion date August 20, 2017

Study information

Verified date July 2018
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are associated with severe dyspnea and exercise intolerance. Early pulmonary rehabilitation (EPR) may lead to improvements in dyspnea and exercise tolerance, as it does in stable COPD patients.


Description:

One hundred and six patients admitted in a university hospital with AECOPD were randomized after discharge to either EPR for 8 weeks (EPR group) or usual care (UC) (UC group). All patients carried out the following initially and after 8 weeks: spirometry, 6minute walk test (SMWT), and a symptom-limited incremental cycle cardiopulmonary exercise test (CPET), and different dyspnea dimensions evaluation as following: Dyspnea intensity during incremental exercise using Borg scale, dyspnea 12 questionnaire and COPD assessment test (CAT) to assess sensory perceptual, affective distress, and symptom impact domains respectively.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date August 20, 2017
Est. primary completion date August 20, 2017
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria:

- Hospitalized COPD patients with a diagnosis of AECOPD with no clinically significant arterial hypoxemia at rest or on exercise (resting percutaneous oxygen saturation (SpO2) > 90% or a sustained decrease of < 4% during exercise) were recruited. Diagnosis of COPD, AECOPD and spirometric assessment of airflow limitation severity was based on Global Initiative for Chronic Obstructive Lung Disease (GOLD)

Exclusion Criteria:

- Patients with a prior diagnosis of other cardiorespiratory conditions (i.e., bronchial asthma, interstitial lung diseases, primary pulmonary hypertension, chronic congestive heart failure), as well as other conditions such as orthopedic, muscular and peripheral vascular diseases that could cause or contribute to breathlessness and exercise intolerance and/or could interfere with carrying out of exercise testing, were excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
pulmonary rehabilitation
pulmonary rehabilitation standardized program

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Outcome

Type Measure Description Time frame Safety issue
Primary change in different aspects of dyspnea (dyspnea 12 questionnaire: scale range 0-36, with high score indicating worse dyspnea, and COPD assessment test: scale range 0-40, high score indicating worse dyspnea). dyspnea questionnaires 8 weeks
Primary change in exercise performance (borg scale during incremental exercise measuring the perceived dyspnea: scale 0-10, higher score indicating worse performance cardiopulmonary exercise tests 8 weeks
Primary change in exercise performance (test duration: longer duration measured in seconds indicating better performance) cardiopulmonary exercise tests 8 weeks
Primary change in exercise performance (Peak oxygen consumption: Higher values indicating better performance) cardiopulmonary exercise tests 8 weeks
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