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

• ClinicalTrials.gov Identifier: NCT03611127
• Recruitment Status: Completed
• First Posted: August 2, 2018
• Last Update Posted: August 2, 2018
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): Amr Shoukri, Ain Shams University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease	Other: pulmonary rehabilitation	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Impact of Early Pulmonary Rehabilitation on the Multidimensional Aspects of Dyspnea and Exercise Performance Following Acute Exacerbation of Chronic Obstructive Pulmonary Disease
• Actual Study Start Date: April 15, 2016
• Actual Primary Completion Date: August 20, 2017
• Actual Study Completion Date: August 20, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: early pulmonary rehabilitation (EPR); early pulmonary rehabilitation started shortly after hospital discharge for COPD exacerbation.	Other: pulmonary rehabilitation; pulmonary rehabilitation standardized program
No Intervention: Usual care (UC); No pulmonary rehabilitation for this group

Outcome Measures

Primary Outcome Measures :

1. 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). [ Time Frame: 8 weeks ]
   dyspnea questionnaires
2. change in exercise performance (borg scale during incremental exercise measuring the perceived dyspnea: scale 0-10, higher score indicating worse performance [ Time Frame: 8 weeks ]
   cardiopulmonary exercise tests
3. change in exercise performance (test duration: longer duration measured in seconds indicating better performance) [ Time Frame: 8 weeks ]
   cardiopulmonary exercise tests
4. change in exercise performance (Peak oxygen consumption: Higher values indicating better performance) [ Time Frame: 8 weeks ]
   cardiopulmonary exercise tests

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Amr Shoukri, Associate Professor of Pulmonary medicine, Ain Shams University
• ClinicalTrials.gov Identifier: NCT03611127
• Other Study ID Numbers: ESR_15_11404_SHOUKRI
• First Posted: August 2, 2018
• Last Update Posted: August 2, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory