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

July 18, 2022 updated by: Alda Sofia Pires de Dias Marques, Aveiro University

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alda S. Marques, PhD
  • Phone Number: 00351 234 372 462
  • Email: amarques@ua.pt

Study Contact Backup

Study Locations

  • Portugal
      • Aveiro, Portugal, 3810-193
        • Recruiting
        • University of Aveiro
        • Contact:
          • Alda S. Marques, PhD
          • Phone Number: 00351 234 372 462
          • Email: amarques@ua.pt
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PR+conventional treatment
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
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.
Other Names:
  • Medication
ACTIVE_COMPARATOR: Conventional treatment
Patients will be treated with daily medication prescribed by the physician.
Drug: Daily medical treatment
Patients will be treated with daily medication prescribed by the physician.
Other Names:
  • Medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity level
Time Frame: assessment at baseline, after 3 weeks (after intervention) and after 2, 6 and 12 months at follow-ups
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
Symptoms of dyspnea
Time Frame: assessment at baseline and after 3 weeks (after intervention)
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)
Symptoms of fatigue
Time Frame: assessment at baseline and after 3 weeks (after intervention)
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)
Lung function measurement
Time Frame: assessment at baseline and after 3 weeks (after intervention)
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)
Change in muscle strength
Time Frame: assessment at baseline and after 3 weeks (after intervention)
Patients' handgrip, biceps and quadriceps muscle strength will be collected with a hand-held dynamometer.
assessment at baseline and after 3 weeks (after intervention)
Change in functional status
Time Frame: assessment at baseline and after 3 weeks (after intervention)
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)
1-minute sit-to-stand test
Time Frame: assessment at baseline and after 3 weeks (after intervention)
The 1-minute sit-to-stand test will be used to also assess functional status.
assessment at baseline and after 3 weeks (after intervention)
Change in exercise capacity
Time Frame: assessment at baseline and after 3 weeks (after intervention)
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)
London Chest Activities of Daily Living
Time Frame: assessment at baseline and after 3 weeks (after intervention)
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)
Cough And Sputum Assessment Questionnaire
Time Frame: assessment at baseline and after 3 weeks (after intervention)
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)
Number of hospitalizations
Time Frame: assessment at baseline and after 2, 6 and 12 months from the end of the intervention (follow-ups)
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)
Re-exacerbations
Time Frame: assessment at baseline and after 2, 6 and 12 months from the end of the intervention (follow-ups)
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)
Mortality
Time Frame: assessment at baseline and after 2, 6 and 12 months from the end of the intervention (follow-ups)
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index
Time Frame: assessment at baseline
Patients' body mass index will be assessed in kg/m^2 based on patients' height and weight.
assessment at baseline
Heart rate
Time Frame: assessment at baseline and 3 weeks after intervention
Heart rate will be assessed in beats per minute using a oximeter and blood pressure meter.
assessment at baseline and 3 weeks after intervention
Respiratory rate
Time Frame: assessment at baseline and 3 weeks after intervention
Respiratory rate will be assessed by direct observation, counting the number of respiratory cycles.
assessment at baseline and 3 weeks after intervention
Blood pressure
Time Frame: assessment at baseline and 3 weeks after intervention
Blood pressure will be assessed using a blood pressure meter.
assessment at baseline and 3 weeks after intervention
Peripheral Oxygen Saturation
Time Frame: assessment at baseline and 3 weeks after intervention
Peripheral oxygen saturation will be assessed with a pulse oximeter.
assessment at baseline and 3 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aveiro University

Collaborators

Fundação para a Ciência e a Tecnologia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2018

Primary Completion (ANTICIPATED)

March 31, 2023

Study Completion (ANTICIPATED)

January 31, 2024

Study Registration Dates

First Submitted

November 13, 2018

First Submitted That Met QC Criteria

November 21, 2018

First Posted (ACTUAL)

November 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFRH/BD/147200/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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