Evidence map›Paper›PMID 41005779›Full record

ArticleBMJ open2025

Effects of an early behavioural change strategy following COPD exacerbation in hospital and outpatient settings in Brazil: protocol for a randomised clinical trial on cardiovascular risk, physical activity and functionality.

Débora Mayumi de Oliveira Kawakami, Manuela Karloh, Gustavo Henrique Guimarães Araujo, Maria Gabriela Colucci, Valéria A Pires Di Lorenzo, Renata Gonçalves Mendes

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Débora Mayumi de Oliveira KawakamiCardiopulmonary Physiotherapy Laboratory (LACAP), Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo, Brazil.ORCID http://orcid.org/0000-0002-6115-261X
Manuela KarlohCenter for Assistance, Teaching, and Research in Pulmonary Rehabilitation (NuReab), Santa Catarina State University, Florianópolis, Santa Catarina, Brazil.
Gustavo Henrique Guimarães AraujoCardiopulmonary Physiotherapy Laboratory (LACAP), Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo, Brazil.
Maria Gabriela ColucciFederal University of São Carlos, São Carlos, São Paulo, Brazil.
Valéria A Pires Di LorenzoFederal University of São Carlos, São Carlos, São Paulo, Brazil.
Renata Gonçalves MendesCardiopulmonary Physiotherapy Laboratory (LACAP), Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo, Brazil renatamendes@ufscar.br.ORCID http://orcid.org/0000-0003-4683-2657

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients living with chronic obstructive pulmonary disease (COPD) experience periods of disease stability and exacerbations (ECOPD). COPD imposes a negative and impactful extrapulmonary impairment and commonly overlaps with multimorbidity, particularly cardiovascular disease. Pulmonary rehabilitation (PR) aims to improve physical activity (PA) and quality of life, while behavioural change interventions (BCIs) aim to promote lifestyle changes and autonomy. However, after ECOPD, a variety of barriers often delay patient referral to PR. This study aims to assess the effects of a BCI for patients after ECOPD, focusing on cardiovascular health, PA and functionality. Additionally, the study will assess 6-month sustainability of PA and conduct a cost-utility analysis comparing a non-intervention group in the Unified Health System. METHODS AND ANALYSIS: This randomised clinical trial will assess patients with ECOPD over 12 weeks using a BCI based on self-determination theory to increase daily steps. First, the cardiovascular and functional profile will be evaluated. Afterwards, the patients will receive an accelerometer to monitor the PA level. After 7 days, questionnaires will be applied on quality of life, symptoms and motivational levels for PA. Patients will be randomised into control group or intervention groups, both will receive educational booklets and IG will also receive an educational interview. PA will be tracked using activPAL accelerometer at weeks 1, 4 and 12, and follow-up at 6 months. Data analysis will include unpaired Student's t-test or Mann-Whitney test for group comparison, and a linear mixed model to assess intervention effects over time. Economic evaluation, using STATA (V.14), will involve correlation analysis, and p<0.05 significance will be considered. ETHICS AND DISSEMINATION: This study has been approved by the Federal University of São Carlos' Ethics Committee, Irmandade Santa Casa de Misericórdia de São Carlos and Base Hospital of São José do Rio Preto. All procedures will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and applicable regulatory requirements. All results will be presented in peer-reviewed medical journals and international conferences. TRIAL REGISTRATION NUMBER: Brazilian Registry of Clinical Trials under the registration number RBR-6m9pwb7.

Indexed as

Behavior TherapyCardiovascular DiseasesExercisePulmonary Disease, Chronic ObstructiveBrazilCost-Benefit AnalysisDisease ProgressionHumansOutpatientsQuality of LifeRandomized Controlled Trials as TopicExerciseRESPIRATORY MEDICINE (see Thoracic Medicine)Risk FactorsWearable Devices

Identifiers

PMID41005779
PMCPMC12481298

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.