NCT03751670

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

Status unknown NA Last updated 8 March 2023

What this trial tests

NA trial testing Pulmonary Rehabilitation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease in 50 participants. Status unknown.

Timeline

1 September 2018

Primary endpoint
31 March 2023

31 January 2024

Quick facts

Lead sponsor	Aveiro University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 September 2018
Primary completion	31 March 2023
Estimated completion	31 January 2024
Sites	1 location across Portugal

Drugs / interventions tested

• Pulmonary Rehabilitation
• Daily medical treatment — full drug profile →

Conditions studied

• Acute Exacerbation of Chronic Obstructive Pulmonary Disease — all drugs for Acute Exacerbation of Chronic Obstructive Pulmonary Disease →

Sponsor

Aveiro University

Who can join

18 and older, any sex, with Acute Exacerbation of Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions for promoting physical activity in people with chronic obstructive pulmonary disease (COPD).
   Burge AT, Cox NS, Abramson MJ, Holland AE. · · 2020 · cited 87× · PMID 32297320 · DOI 10.1002/14651858.cd012626.pub2
2. Short-term effects of home-based pulmonary rehabilitation during outpatient-managed exacerbations of COPD: a randomised controlled trial.
   Machado A, Dias C, Paixão C, Gonçalves AP, et al · · 2025 · cited 2× · PMID 39689939 · DOI 10.1136/thorax-2024-221760