Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseNCT03751670
Pulmonary Rehabilitation During Acute Exacerbations of Chronic Obstructive Pulmonary Disease: a Mixed-methods Approach
A study testing Pulmonary Rehabilitation and Daily medical treatment in people with Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Aveiro University at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- What is being tested?
- Pulmonary Rehabilitation and Daily medical treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2018to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary Rehabilitation During Acute Exacerbations of Chronic Obstructive
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.
Read more
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.
Read the detailed description
Acute exacerbations of COPD (AECOPD) negatively impact on patients' health status and disease progression, and increase patients' susceptibility to exacerbations, hospitalizations and death. Therefore, the treatment goals for patients with AECOPD are to minimize the negative impact of these events and prevent their recurrence.
Pulmonary rehabilitation (PR) is the comprehensive intervention presenting the most well-established benefits in patients with stable COPD, thus, it would seem reasonable to consider PR as a management strategy for AECOPD. However, studies assessing PR role during AECOPD have shown conflicting results.
Therefore, the main aim of this project is to assess the short-, mid- and long-term effectiveness of a patient-centered community-based PR programme during AECOPD. Secondarily, we aim to develop and implement a community-based PR programme for patients with AECOPD, specifically tailored to their self-reported and clinical needs; establish the minimal clinical important differences for PR in AECOPD for clinical and patient-reported outcome measures; and evaluate patients' perspectives and self-reported impact of the PR programme.
A pilot study was performed between November 2016 and December 2017 to allow sample size calculation and adjustments to the protocol of the randomized controlled trial. Based on this pilot study, a sample size estimation was performed for the COPD Assessment Test to detect a moderate effect size (f=0.30), with 80% power, 5% significance level and moderate correlation among repeated measures (r=0.25). The minimum sample size estimation was 36 participants. However, as in respiratory interventions dropout rates are around 30-35%, a total of 50 participants with AECOPD will be needed.
The plan is to recruit approximately 50 voluntary patients with AECOPD via clinicians at hospitals and primary care centres. This study will enroll adult patients diagnosed with AECOPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
Patients will be recruited via the clinicians, who will provide a brief explanation about the study and inform the researcher about interested participants. Then, the researcher will contact interested participants and provide further information about the study, clarify any doubts and collect the inform consents. Patients will be eligible if they are: i) diagnosed with AECOPD according to the GOLD criteria; ii) included within 24-48h of the diagnostic; and iii) able to provide informed consent. Exclusion criteria will include: i) need for hospitalization; ii) other coexisting chronic respiratory diseases; iii) unstable cardiovascular disease; iv) musculoskeletal or neuromuscular conditions that preclude the performance of the assessments and/or treatment sessions; v) signs of cognitive impairment; vi) current neoplasia or immunological disease and vii) any therapeutic intervention in addition to standard of care.
Patients who agree to participate will be randomly allocated to the conventional treatment group (control group) or the conventional treatment plus PR group (experimental group).
Baseline data will be collected within the first 24-48 hours of the diagnosis of AECOPD. The researcher will collect sociodemographic, anthropometric and clinical data (e.g., number of exacerbations in the previous year); vital signs and peripheral oxygen saturation; symptoms (dyspnoea, fatigue, cough and sputum); lung function (spirometry); physical activity level; peripheral muscle strength (handgrip and hand-held dynamometer); functional status; exercise tolerance; impact of the disease and health-related quality of life.
Patients in the control group will receive daily medical treatment prescribed by the physician (i.e., medication).
Patients in the experimental group will receive daily medical treatment plus a community-based PR programme that will involve 6 sessions (2 times per week). The PR programme will consist of breathing retraining and airway clearance techniques, exercises for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training, education and psychosocial support. This programme will be adjusted to each individual needs. After this period all measurements will be repeated. Furthermore, vital signs, peripheral oxygen saturation, dyspnoea and fatigue will also be collected before/during/after each session to monitor the intervention. Sessions will be conducted in properly equipped rooms or at patients' home and will last approximately 60 minutes.
Additionally, after 2, 6 and 12 months, the researcher will contact all participants via phone calls to collect data about the number of recurrent AECOPD, healthcare utilization (e.g., unscheduled visits, hospitalizations) and mortality.
Data analysis will be undertaken using Statistical Package for the Social Sciences (SPSS) software and will include descriptive and inferential statistics. To analyse changes in outcome measures, data from baseline and after treatment assessments will be compare. Moreover, between group comparisons will also be performed for baseline, after intervention and follow-ups assessments. Effect sizes for the interventions will also be calculated.
- Being tested
- Pulmonary Rehabilitation, Daily medical treatment
- Keywords
- Acute exacerbation of chronic obstructive pulmonary disease, Pulmonary rehabilitation, Community, Home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationOther
Pulmonary Rehabilitation programmes will include breathing retraining and airway clearance techniques, exercises for thoracic mobility, muscle strength, cardiorespiratory exercise training, education and psychosocial support.
Daily medical treatmentDrug
Also called Medication
Patients will be treated with daily medication prescribed by the physician.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pulmonary Rehabilitation; Drug: Daily medical treatment |
| Conventional treatment | Active comparator | Patients will be treated with daily medication prescribed by the physician. Receives: Drug: Daily medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Patients' physical activity level will be assessed with the brief physical activity assessment tool, which is a simple, quick and reliable instrument that is being validated for use in COPD and has been significantly correlated with the international physical activity questionnaire (r=0.523, p<0.001), accelerometers (r=0.529, p<0.001) and daily steps (r=0.565, p<0.001). It comprises two questions regarding the frequency and duration of moderate and vigorous physical activity undertaken in an usual week. Each question is scored from 0 to 4 and the total score consists of summing the result of the two questions, ranging from 0 to 8. Scores of 0-3 are considered "insufficiently active", and scores higher or equal to 4 "sufficiently active".
Measured: assessment at baseline, after 3 weeks (after intervention) and after 2, 6 and 12 months at follow-ups
Symptoms of dyspnea
Patients' self-reported level of dyspnea will be collected at rest, using the modified Borg scale. The level of dyspnea during activities will be collected with the modified British Medical Research Council questionnaire, which comprises five grades (statements) in a scale from 0 to 4, with higher grades indicating greater perceived respiratory limitation.
Measured: assessment at baseline and after 3 weeks (after intervention)
Symptoms of fatigue
Patients' self-reported level of fatigue will be collected at rest, using the modified Borg scale. The level of fatigue on a daily basis will be collected with the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and the Checklist of Individual Strength 8 (CIS-8).
Measured: assessment at baseline and after 3 weeks (after intervention)
Lung function measurement
A spirometry test will be performed with a portable spirometer to assess the force expiratory volume in 1 second and, therefore, the degree of bronchial obstruction.
Measured: assessment at baseline and after 3 weeks (after intervention)
Change in muscle strength
Patients' handgrip, biceps and quadriceps muscle strength will be collected with a hand-held dynamometer.
Measured: assessment at baseline and after 3 weeks (after intervention)
Change in functional status
Patients' functional level will be assessed with the short physical performance battery, a simple and easy to perform tool that includes the four-meter gait speed test, the five-repetition sit-to-stand test and a balance test, and gives a total score based on the performance in each of those tests.
Measured: assessment at baseline and after 3 weeks (after intervention)
1-minute sit-to-stand test
The 1-minute sit-to-stand test will be used to also assess functional status.
Measured: assessment at baseline and after 3 weeks (after intervention)
Change in exercise capacity
Patients' exercise capacity will be assessed using the Chester step test, since it allows exercise prescription and is feasible in the community and at patients' home. Additionally, patients assessed in the community, at the facilities of University of Aveiro, will also perform the 6-minutes walk test to assess their exercise capacity.
Measured: assessment at baseline and after 3 weeks (after intervention)
London Chest Activities of Daily Living
Patients' level of dyspnoea performing activities of daily living and functional status will be assessed with th London Chest Activities of Daily Living questionnaire.
Measured: assessment at baseline and after 3 weeks (after intervention)
Cough And Sputum Assessment Questionnaire
Patients' symptoms of cough and sputum will be assessed with the Cough And Sputum Assessment Questionnaire (CASA-Q).
Measured: assessment at baseline and after 3 weeks (after intervention)
Number of hospitalizations
Patients' number of hospitalizations in the previous year and during the follow-up period after the acute exacerbation will be assessed by asking the patient to self-report it.
Measured: assessment at baseline and after 2, 6 and 12 months from the end of the intervention (follow-ups)
Re-exacerbations
Patients' number of re-exacerbations after being included in the study will be assessed by asking the patient to self-report it.
Measured: assessment at baseline and after 2, 6 and 12 months from the end of the intervention (follow-ups)
Mortality
The number of patients who died after the acute exacerbation, up to the 1 year follow-up period, will be collected.
Measured: assessment at baseline and after 2, 6 and 12 months from the end of the intervention (follow-ups)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start1 Sep 2018
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Responsible party
- Principal investigator, Alda Sofia Pires de Dias Marques, Aveiro University
- Investigators
- Alda S. Marques, PhD, Principal investigator, School of Health Sciences of the University of Aveiro (ESSUA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751670
- Sponsor's protocol ID
- SFRH/BD/147200/2019
- Status last verified
- Mar 2023
- First submitted
- 13 Nov 2018
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30512981Oliveira 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.
PubMed 30554671Oliveira 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.
PubMed 30538438Oliveira 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.
PubMed 29228288Oliveira 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.
PubMed 26067286Oliveira 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.
PubMed 26471240Machado A, Oliveira A, Valente C, Burtin C, Marques A (2018) "Community-based pulmonary rehabilitation during acute exacerbations of COPD" European Respiratory Journal
Machado A, Silva P, Marques A (2018) "Design of pulmonary rehabilitation during acute exacerbations of COPD". European Respiratory Journal
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
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
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.
PubMed 31164288Machado 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.
PubMed 31601490Machado 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.
PubMed 39689939
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Rehabilitation During Acute Exacerbations of Chronic Obstructive
- ClinicalTrials.gov ID
- NCT03751670
- Acronym / sponsor ID
- SFRH/BD/147200/2019
- Keywords
- Acute exacerbation of chronic obstructive pulmonary disease, Pulmonary rehabilitation, Community, Home
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acute exacerbations of COPD (AECOPD) negatively impact on patients' health status and disease progression, and increase patients' susceptibility to exacerbations, hospitalizations and death. Therefore, the treatment goals for patients with AECOPD are to minimize the negative impact of these events and prevent their recurrence.
Pulmonary rehabilitation (PR) is the comprehensive intervention presenting the most well-established benefits in patients with stable COPD, thus, it would seem reasonable to consider PR as a management strategy for AECOPD. However, studies assessing PR role during AECOPD have shown conflicting results.
Therefore, the main aim of this project is to assess the short-, mid- and long-term effectiveness of a patient-centered community-based PR programme during AECOPD. Secondarily, we aim to develop and implement a community-based PR programme for patients with AECOPD, specifically tailored to their self-reported and clinical needs; establish the minimal clinical important differences for PR in AECOPD for clinical and patient-reported outcome measures; and evaluate patients' perspectives and self-reported impact of the PR programme.
A pilot study was performed between November 2016 and December 2017 to allow sample size calculation and adjustments to the protocol of the randomized controlled trial. Based on this pilot study, a sample size estimation was performed for the COPD Assessment Test to detect a moderate effect size (f=0.30), with 80% power, 5% significance level and moderate correlation among repeated measures (r=0.25). The minimum sample size estimation was 36 participants. However, as in respiratory interventions dropout rates are around 30-35%, a total of 50 participants with AECOPD will be needed.
The plan is to recruit approximately 50 voluntary patients with AECOPD via clinicians at hospitals and primary care centres. This study will enroll adult patients diagnosed with AECOPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
Patients will be recruited via the clinicians, who will provide a brief explanation about the study and inform the researcher about interested participants. Then, the researcher will contact interested participants and provide further information about the study, clarify any doubts and collect the inform consents. Patients will be eligible if they are: i) diagnosed with AECOPD according to the GOLD criteria; ii) included within 24-48h of the diagnostic; and iii) able to provide informed consent. Exclusion criteria will include: i) need for hospitalization; ii) other coexisting chronic respiratory diseases; iii) unstable cardiovascular disease; iv) musculoskeletal or neuromuscular conditions that preclude the performance of the assessments and/or treatment sessions; v) signs of cognitive impairment; vi) current neoplasia or immunological disease and vii) any therapeutic intervention in addition to standard of care.
Patients who agree to participate will be randomly allocated to the conventional treatment group (control group) or the conventional treatment plus PR group (experimental group).
Baseline data will be collected within the first 24-48 hours of the diagnosis of AECOPD. The researcher will collect sociodemographic, anthropometric and clinical data (e.g., number of exacerbations in the previous year); vital signs and peripheral oxygen saturation; symptoms (dyspnoea, fatigue, cough and sputum); lung function (spirometry); physical activity level; peripheral muscle strength (handgrip and hand-held dynamometer); functional status; exercise tolerance; impact of the disease and health-related quality of life.
Patients in the control group will receive daily medical treatment prescribed by the physician (i.e., medication).
Patients in the experimental group will receive daily medical treatment plus a community-based PR programme that will involve 6 sessions (2 times per week). The PR programme will consist of breathing retraining and airway clearance techniques, exercises for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training, education and psychosocial support. This programme will be adjusted to each individual needs. After this period all measurements will be repeated. Furthermore, vital signs, peripheral oxygen saturation, dyspnoea and fatigue will also be collected before/during/after each session to monitor the intervention. Sessions will be conducted in properly equipped rooms or at patients' home and will last approximately 60 minutes.
Additionally, after 2, 6 and 12 months, the researcher will contact all participants via phone calls to collect data about the number of recurrent AECOPD, healthcare utilization (e.g., unscheduled visits, hospitalizations) and mortality.
Data analysis will be undertaken using Statistical Package for the Social Sciences (SPSS) software and will include descriptive and inferential statistics. To analyse changes in outcome measures, data from baseline and after treatment assessments will be compare. Moreover, between group comparisons will also be performed for baseline, after intervention and follow-ups assessments. Effect sizes for the interventions will also be calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| PR+conventional treatment | Experimental | Other: Pulmonary Rehabilitation, Drug: Daily medical treatmentPatients 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. |
| Conventional treatment | Active comparator | Drug: Daily medical treatmentPatients will be treated with daily medication prescribed by the physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary RehabilitationPulmonary Rehabilitation programmes will include breathing retraining and airway clearance techniques, exercises for thoracic mobility, muscle strength, cardiorespiratory exercise training, education and psychosocial support. | Other | PR+conventional treatment |
| Daily medical treatmentAlso: MedicationPatients will be treated with daily medication prescribed by the physician. | Drug | Conventional treatment, PR+conventional treatment |
Primary outcome
COPD Assessment test
Time frame: 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.
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).
13 secondary outcomes
Physical activity level
Time frame: assessment at baseline, after 3 weeks (after intervention) and after 2, 6 and 12 months at follow-ups
Symptoms of dyspnea
Time frame: assessment at baseline and after 3 weeks (after intervention)
Symptoms of fatigue
Time frame: assessment at baseline and after 3 weeks (after intervention)
Lung function measurement
Time frame: assessment at baseline and after 3 weeks (after intervention)
Change in muscle strength
Time frame: assessment at baseline and after 3 weeks (after intervention)
Change in functional status
Time frame: assessment at baseline and after 3 weeks (after intervention)
1-minute sit-to-stand test
Time frame: assessment at baseline and after 3 weeks (after intervention)
Change in exercise capacity
Time frame: assessment at baseline and after 3 weeks (after intervention)
London Chest Activities of Daily Living
Time frame: assessment at baseline and after 3 weeks (after intervention)
Cough And Sputum Assessment Questionnaire
Time frame: assessment at baseline and after 3 weeks (after intervention)
Number of hospitalizations
Time frame: assessment at baseline and after 2, 6 and 12 months from the end of the intervention (follow-ups)
Re-exacerbations
Time frame: assessment at baseline and after 2, 6 and 12 months from the end of the intervention (follow-ups)
Mortality
Time frame: assessment at baseline and after 2, 6 and 12 months from the end of the intervention (follow-ups)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Background: PubMed 30512981Oliveira 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.
- Background: PubMed 30554671Oliveira 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.
- Background: PubMed 30538438Oliveira 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.
- Background: PubMed 29228288Oliveira 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.
- Background: PubMed 26067286Oliveira 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.
- Background: PubMed 26471240Oliveira 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.
- BackgroundMachado A, Oliveira A, Valente C, Burtin C, Marques A (2018) "Community-based pulmonary rehabilitation during acute exacerbations of COPD" European Respiratory Journal
- BackgroundMachado A, Silva P, Marques A (2018) "Design of pulmonary rehabilitation during acute exacerbations of COPD". European Respiratory Journal
- BackgroundOliveira 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
- BackgroundMachado 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: PubMed 31164288Machado 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.
- Background: PubMed 31601490Machado 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alda S. Marques, PhD principal investigator
School of Health Sciences of the University of Aveiro (ESSUA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation and Daily medical treatment in people with Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Aveiro University at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD Assessment test (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03751670, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.