Kawakami Débora Mayumi de Oliveira, Karloh Manuela, Araujo Gustavo Henrique Guimarães, Colucci Maria Gabriela, Pires Di Lorenzo Valéria A, Mendes Renata Gonçalves
Cardiopulmonary Physiotherapy Laboratory (LACAP), Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo, Brazil.
Center for Assistance, Teaching, and Research in Pulmonary Rehabilitation (NuReab), Santa Catarina State University, Florianópolis, Santa Catarina, Brazil.
BMJ Open. 2025 Sep 26;15(9):e097954. doi: 10.1136/bmjopen-2024-097954.
Patients 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.
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.
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.
Brazilian Registry of Clinical Trials under the registration number RBR-6m9pwb7.
慢性阻塞性肺疾病（COPD）患者会经历疾病稳定期和急性加重期（ECOPD）。COPD会造成负面且有影响的肺外功能损害，并且通常与多种疾病并存，尤其是心血管疾病。肺康复（PR）旨在改善身体活动（PA）和生活质量，而行为改变干预（BCI）旨在促进生活方式改变和自主性。然而，在ECOPD之后，各种障碍常常会延迟患者接受PR治疗。本研究旨在评估BCI对ECOPD后患者的影响，重点关注心血管健康、PA和功能。此外，该研究将评估PA的6个月可持续性，并进行成本效益分析，与统一卫生系统中的非干预组进行比较。
这项随机临床试验将使用基于自我决定理论的BCI对ECOPD患者进行为期12周的评估，以增加每日步数。首先，将评估心血管和功能状况。之后，患者将获得一个加速度计以监测PA水平。7天后，将应用关于生活质量、症状和PA动机水平的问卷。患者将被随机分为对照组或干预组，两组都将收到教育手册，干预组还将接受一次教育访谈。将在第1、4和12周使用activPAL加速度计跟踪PA，并在6个月时进行随访。数据分析将包括用于组间比较的非配对学生t检验或曼-惠特尼检验，以及用于评估随时间变化的干预效果的线性混合模型。使用STATA（V.14）进行的经济评估将涉及相关性分析，p<0.05的显著性将被视为有统计学意义。
本研究已获得圣卡洛斯联邦大学伦理委员会、圣卡洛斯仁慈圣母医院和里奥普雷图河畔圣若泽基础医院的批准。所有程序将按照《赫尔辛基宣言》、《良好临床实践指南》和适用的监管要求进行。所有结果将在同行评审的医学期刊和国际会议上发表。
巴西临床试验注册中心注册号为RBR-6m9pwb7。
