The Impact of Early Pulmonary Rehabilitation on Multidimensional Aspect of Dyspnea in COPD Patients After Exacerbation

NCT03611127 | Completed

• 1 other identifier: ESR_15_11404_SHOUKRI
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• change in exercise performance (test duration: longer duration measured in seconds indicating better performance)

  cardiopulmonary exercise tests

  8 weeks

• change in exercise performance (Peak oxygen consumption: Higher values indicating better performance)

  cardiopulmonary exercise tests

  8 weeks

Study Arms (2)

early pulmonary rehabilitation (EPR)

EXPERIMENTAL

early pulmonary rehabilitation started shortly after hospital discharge for COPD exacerbation.

Other: pulmonary rehabilitation

Usual care (UC)

NO INTERVENTION

No pulmonary rehabilitation for this group

Interventions

pulmonary rehabilitation OTHER

pulmonary rehabilitation standardized program

early pulmonary rehabilitation (EPR)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pulmonary medicine

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: August 2, 2018
• Study Start: April 15, 2016
• Primary Completion: August 20, 2017
• Study Completion: August 20, 2017
• Last Updated: August 2, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share