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

Acute Exacerbation of Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Pulmonary Rehabilitation During Acute Exacerbations of Chronic Obstructive

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03751670
• Other study ID #: SFRH/BD/147200/2019
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: January 31, 2024

Study information

• Verified date: March 2023
• Source: Aveiro University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: January 31, 2024
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Acute Exacerbation of Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Drug:
• Daily medical treatment
Patients will be treated with daily medication prescribed by the physician.

Locations

Country	Name	City	State
Portugal	University of Aveiro	Aveiro

Sponsors (2)

Lead Sponsor	Collaborator
Aveiro University	Fundação para a Ciência e a Tecnologia

Country where clinical trial is conducted

Portugal, 

References & Publications (12)

Machado A, Matos Silva P, Afreixo V, Caneiras C, Burtin C, Marques A. Design of pulmonary rehabilitation programmes during acute exacerbations of COPD: a systematic review and network meta-analysis. Eur Respir Rev. 2020 Nov 18;29(158):200039. doi: 10.1183/16000617.0039-2020. Print 2020 Dec 31. Erratum In: Eur Respir Rev. 2021 Feb 9;30(159): — View Citation

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 (2018) "Community-based pulmonary rehabilitation during acute exacerbations of COPD" European Respiratory Journal

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body mass index	Patients' body mass index will be assessed in kg/m^2 based on patients' height and weight.	assessment at baseline
Other	Heart rate	Heart rate will be assessed in beats per minute using a oximeter and blood pressure meter.	assessment at baseline and 3 weeks after intervention
Other	Respiratory rate	Respiratory rate will be assessed by direct observation, counting the number of respiratory cycles.	assessment at baseline and 3 weeks after intervention
Other	Blood pressure	Blood pressure will be assessed using a blood pressure meter.	assessment at baseline and 3 weeks after intervention
Other	Peripheral Oxygen Saturation	Peripheral oxygen saturation will be assessed with a pulse oximeter.	assessment at baseline and 3 weeks after intervention
Primary	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	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".	assessment at baseline, after 3 weeks (after intervention) and after 2, 6 and 12 months at follow-ups
Secondary	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.	assessment at baseline and after 3 weeks (after intervention)
Secondary	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).	assessment at baseline and after 3 weeks (after intervention)
Secondary	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.	assessment at baseline and after 3 weeks (after intervention)
Secondary	Change in muscle strength	Patients' handgrip, biceps and quadriceps muscle strength will be collected with a hand-held dynamometer.	assessment at baseline and after 3 weeks (after intervention)
Secondary	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.	assessment at baseline and after 3 weeks (after intervention)
Secondary	1-minute sit-to-stand test	The 1-minute sit-to-stand test will be used to also assess functional status.	assessment at baseline and after 3 weeks (after intervention)
Secondary	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.	assessment at baseline and after 3 weeks (after intervention)
Secondary	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.	assessment at baseline and after 3 weeks (after intervention)
Secondary	Cough And Sputum Assessment Questionnaire	Patients' symptoms of cough and sputum will be assessed with the Cough And Sputum Assessment Questionnaire (CASA-Q).	assessment at baseline and after 3 weeks (after intervention)
Secondary	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.	assessment at baseline and after 2, 6 and 12 months from the end of the intervention (follow-ups)
Secondary	Re-exacerbations	Patients' number of re-exacerbations after being included in the study will be assessed by asking the patient to self-report it.	assessment at baseline and after 2, 6 and 12 months from the end of the intervention (follow-ups)
Secondary	Mortality	The number of patients who died after the acute exacerbation, up to the 1 year follow-up period, will be collected.	assessment at baseline and after 2, 6 and 12 months from the end of the intervention (follow-ups)