Pulmonary Rehabilitation During Acute Exacerbations of Chronic Obstructive Pulmonary Disease: a Mixed-methods Approach

NCT03751670 | Unknown

• 1 other identifier: SFRH/BD/147200/2019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to i) assess the short-, mid- and long-term effectiveness of a patient-centred community-based pulmonary rehabilitation (PR) programme during during acute exacerbations of chronic obstructive pulmonary disease (AECOPD); ii) establish the minimal clinical important differences for PR in AECOPD for clinical and patient-reported outcome measures; and iii) evaluate patients' perspectives and self-reported impact of the PR programme. Patients with AECOPD will be recruited via clinicians at hospitals and primary care centres. Sociodemographic, anthropometric and clinical data; vital signs and peripheral oxygen saturation; symptoms (dyspnoea, fatigue, cough and sputum); lung function; physical activity level; peripheral muscle strength; functional status; exercise tolerance; impact of the disease and health-related quality of life will be collected within 24h-48h of the AECOPD diagnosis. Then, patients will be randomly allocated to either conventional treatment or conventional treatment plus PR. After 3 weeks, all outcome measures will be reassessed. Additionally, follow-ups at 2, 6 and 12 months will be performed through phone calls to assess the number of recurrent AECOPD, healthcare utilization and mortality. Conventional treatment will consist on daily medical treatment prescribed by the physician (i.e., medication). Community-based PR will involve 6 sessions (2 times per week) of breathing retraining and airway clearance techniques, exercises for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training, education and psychosocial support. It is expected that, by including PR in the treatment of patients with AECOPD, they will express greater improvements in a shorter period of time and experience a decrease number of re-exacerbations and healthcare utilization.

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Keywords

Acute exacerbation of chronic obstructive pulmonary disease; Pulmonary rehabilitation; Community; Home

Outcome Measures

Primary Outcomes (1)

• COPD Assessment test

  Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) is a short, simple, multidimensional, easy to administer and disease-specific questionnaire that measures impact of the disease. CAT consists of eight items (i.e., cough, sputum, chest tightness, breathlessness going up hills/stairs, activity limitations at home, confidence leaving home, sleep and energy) scored from 0 to 5. The individual score of each item is added to provide a total score that can range from 0 to 40. Total scores inferior to 10 are considered as "reduced impact", from 10-20 as "medium impact", from 21- 30 as "high impact" and above 30 as "very high impact". This is a valid and reliable instrument for use in patients with AECOPD (Chronbach's alpha=0.88).

  24-48 hours after hospital presentation or at clinical stabilization (baseline), after 3 weeks (after intervention) and after 2, 6 and 12 months at follow-ups.

Secondary Outcomes (13)

• Physical activity level

  assessment at baseline, after 3 weeks (after intervention) and after 2, 6 and 12 months at follow-ups

• Symptoms of dyspnea

  assessment at baseline and after 3 weeks (after intervention)

• Symptoms of fatigue

  assessment at baseline and after 3 weeks (after intervention)

• Lung function measurement

  assessment at baseline and after 3 weeks (after intervention)

• Change in muscle strength

  assessment at baseline and after 3 weeks (after intervention)

Other Outcomes (5)

• Body mass index

  assessment at baseline

• Heart rate

  assessment at baseline and 3 weeks after intervention

• Respiratory rate

  assessment at baseline and 3 weeks after intervention

Study Arms (2)

PR+conventional treatment

EXPERIMENTAL

Patients will be treated with daily medication prescribed by the physician. Additionally, patients will receive 6 sessions (2 times a week during 3 weeks) of Pulmonary Rehabilitation (PR). PR will include breathing retraining and airway clearance techniques, exercises for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training, education and psychosocial support.

Other: Pulmonary Rehabilitation; Drug: Daily medical treatment

Conventional treatment

ACTIVE COMPARATOR

Patients will be treated with daily medication prescribed by the physician.

Drug: Daily medical treatment

Interventions

Pulmonary Rehabilitation OTHER

Pulmonary Rehabilitation programmes will include breathing retraining and airway clearance techniques, exercises for thoracic mobility, muscle strength, cardiorespiratory exercise training, education and psychosocial support.

PR+conventional treatment

Daily medical treatment DRUG

Patients will be treated with daily medication prescribed by the physician.

Also known as: Medication

Conventional treatment; PR+conventional treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of AECOPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria (i.e., an episode of acute worsening of respiratory symptoms that result in additional therapy);
• included within 24-48h of the diagnostic;
• able to provide their own informed consent.

You may not qualify if:

• need for hospitalization;
• other coexisting chronic respiratory diseases;
• unstable cardiovascular disease;
• presence of musculoskeletal or neuromuscular conditions that preclude the performance of any of the assessments or the participation in the treatment sessions;
• signs of cognitive impairment;
• current neoplasia or immunological disease;
• any therapeutic intervention in addition to standard of care.

Sponsors & Collaborators

• Aveiro University: lead
• Fundação para a Ciência e a Tecnologia: collaborator

Study Sites (1)

University of Aveiro

Aveiro, 3810-193, Portugal

Location

Related Publications (13)

• Oliveira A, Machado A, Marques A. Minimal Important and Detectable Differences of Respiratory Measures in Outpatients with AECOPDdagger. COPD. 2018 Oct;15(5):479-488. doi: 10.1080/15412555.2018.1537366. Epub 2018 Dec 4.

  PMID: 30512981 BACKGROUND

• Oliveira A, Marques A. Understanding symptoms variability in outpatients with AECOPD. Pulmonology. 2018 Nov-Dec;24(6):357-360. doi: 10.1016/j.pulmoe.2018.09.007. No abstract available.

  PMID: 30554671 BACKGROUND

• Oliveira A, Afreixo V, Marques A. Enhancing our understanding of the time course of acute exacerbations of COPD managed on an outpatient basis. Int J Chron Obstruct Pulmon Dis. 2018 Nov 20;13:3759-3766. doi: 10.2147/COPD.S175890. eCollection 2018.

  PMID: 30538438 BACKGROUND

• Oliveira AL, Marques AS. Outcome Measures Used in Pulmonary Rehabilitation in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Systematic Review. Phys Ther. 2018 Mar 1;98(3):191-204. doi: 10.1093/ptj/pzx122.

  PMID: 29228288 BACKGROUND

• Oliveira A, Marques A. Exploratory mixed methods study of respiratory physiotherapy for patients with lower respiratory tract infections. Physiotherapy. 2016 Mar;102(1):111-8. doi: 10.1016/j.physio.2015.03.3723. Epub 2015 May 14.

  PMID: 26067286 BACKGROUND

• Oliveira A, Pinho C, Marques A. Effects of a respiratory physiotherapy session in patients with LRTI: a pre/post-test study. Clin Respir J. 2017 Nov;11(6):703-712. doi: 10.1111/crj.12402. Epub 2015 Nov 5.

  PMID: 26471240 BACKGROUND

• Machado A, Oliveira A, Valente C, Burtin C, Marques A (2018) "Community-based pulmonary rehabilitation during acute exacerbations of COPD" European Respiratory Journal

  BACKGROUND

• Machado A, Silva P, Marques A (2018) "Design of pulmonary rehabilitation during acute exacerbations of COPD". European Respiratory Journal

  BACKGROUND

• Oliveira A, Rebelo P, Andrade L, Valente C, Marques A (2018) "Computerised respiratory sounds during acute exacerbations of Chronic Obstructive Pulmonary Disease". Proceedings of the 4th IPLeiria's International Health Congress. BMC Health Services Research 2018, 18(Suppl 2): O23 pp 13

  BACKGROUND

• Machado A, Oliveira A, Paixão C, Miranda S, Melro H, Ferreira D, Marques A (2017) "Pulmonary rehabilitation effects on computerized respiratory sounds of patients with AECOPD" Proceedings of the 42nd Annual Conference of the International Lung Sound Association, 182:57

  BACKGROUND

• Machado A, Oliveira A, Valente C, Burtin C, Marques A. Effects of a community-based pulmonary rehabilitation programme during acute exacerbations of chronic obstructive pulmonary disease - A quasi-experimental pilot study. Pulmonology. 2020 Jan-Feb;26(1):27-38. doi: 10.1016/j.pulmoe.2019.05.004. Epub 2019 Jun 1.

  PMID: 31164288 BACKGROUND

• Machado A, Oliveira A, Valente C, Burtin C, Marques A. Effects of a community-based pulmonary rehabilitation programme during acute exacerbations of chronic obstructive pulmonary disease - A quasi-experimental pilot study. Authors' reply. Pulmonology. 2020 Mar-Apr;26(2):112-113. doi: 10.1016/j.pulmoe.2019.09.001. Epub 2019 Oct 8. No abstract available.

  PMID: 31601490 BACKGROUND

• Machado A, Dias C, Paixao C, Goncalves AP, Burtin C, Marques A. Short-term effects of home-based pulmonary rehabilitation during outpatient-managed exacerbations of COPD: a randomised controlled trial. Thorax. 2025 Mar 18;80(4):218-226. doi: 10.1136/thorax-2024-221760.

  PMID: 39689939 DERIVED

MeSH Terms

Interventions

Dosage Forms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Alda S. Marques, PhD

  School of Health Sciences of the University of Aveiro (ESSUA)

  PRINCIPAL INVESTIGATOR

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: Senior Lecturer

Model Details: Participants are assigned to one of two groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 23, 2018
• Study Start: September 1, 2018
• Primary Completion: March 31, 2023
• Study Completion: January 31, 2024
• Last Updated: March 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)