Skip to content

Efficacy of behavioral change on cardiovascular system, physical activity level and functionality after exacerbation of Chronic Obstructive Pulmonary Disease

Efficacy of an early behavioral behavioral strategy after acute exacerbation of Lung Disease on cardiovascular profile, physical activity level, and functioning: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6m9pwb7
Enrollment
Unknown
Registered
2023-07-31
Start date
2022-11-21
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

This is a randomized clinical trial with follow-up where data will be collected from patients admitted to wards within a period of 14 weeks after hospital discharge and will be followed up to 12 month
F02.784.176

Sponsors

Universidade Federal de São Carlos
Lead Sponsor
Santa Casa de Misericórdia de São Carlos
Collaborator

Eligibility

Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients of both genders will be included in the study; diagnosed with Chronic Obstructive Pulmonary Disease according to the classification of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) system (forced expiratory volume in 1 second/forced vital capacity less than 70% post-bronchodilator; stage 2 (less than or equal to 50% of forced expiratory volume in 1 second and less than 80% of predicted); stage 3 (less than or equal to 50% of forced expiratory volume in 1 second and less than 30% of predicted); aged 40 to 80 years; that the cause of hospitalization is the exacerbation of Chronic Obstructive Pulmonary Disease, who are breathing spontaneously and clinically stable before hospital discharge

Exclusion criteria

Exclusion criteria: Patients with cognitive impairment (Mini Mental <20); have unstable heart disease; neurological disease; walking difficulties; persistent arrhythmias; acute myocardial infarction (<6 months); stroke; neoplasm undergoing chemotherapy; patients who have another associated lung disease or musculoskeletal disease that compromises mobility; systemic arterial hypertension or uncontrolled diabetes mellitus; who had participated in a pulmonary rehabilitation program 3 months before the exacerbation; patients with moderate and high risk of falling (Morse fall scale =24 points); pregnant or puerperal women and patients who do not have access to a cell or landline telephone. During the follow-up period, those patients who are hospitalized during the collection period will be excluded

Design outcomes

Primary

MeasureTime frame
The hypothesis of the present study is that patients undergoing intervention based on behavioral change will present better outcomes, such as an improvement in cardiovascular function observed from a greater response observed in the assessment of flow-mediated vasodilation (FMD) of the brachial artery, reduction in arterial stiffness verified through analysis of the carotid-femoral artery pulse wave velocity and better cardiac autonomic control evaluated through heart rate variability

Secondary

MeasureTime frame
The hypothesis of the present study is that patients undergoing intervention based on behavioral change will present better outcomes, such as an increase in the level of physical activity assessed using the ActivPALM3® accelerometer and motivational questionnaires for physical activity: Behavioral Regulation in Exercise - Questionnaire 2 ( BREQ-2), Basic Psychological Needs in Exercise Scale (BPNES), The COPD Self-Efficacy Scale, Global Rating Scale Change;The hypothesis of the present study is that patients undergoing intervention based on behavioral change will have better outcomes such as improvement in functionality assessed through the 6-minute walk test and handgrip strength;The hypothesis of the present study is that patients undergoing intervention based on behavioral change will have better outcomes, such as reduced symptoms and improved quality of life, assessed using questionnaires: COPD Assessment Test™ (CAT), Medical Research Council (MRC dyspnea) , EUROQOL (EQ-5D-3L), Duke Activity Status Index (DASI), London Chest Activity of Daily Living (LCADL);In the follow-up of 6 and 12 months, the hypothesis of the present study is that the patients submitted to the intervention based on the behavior change, will present better regulations of behavior of the motivation characterize a self-determined profile for behavior change in relation to the physical exercise and that the increase of the physical activity level will be associated with better exercise capacity in the 6MWT and with ventilatory and cardiac responses during the 6-minute walk test;In addition, the cost-effectiveness of the intervention will also be evaluated and we believe that the intervention will reduce hospitalization costs by reducing the number of exacerbations

Countries

Brazil

Contacts

Public ContactRenata Mendes

Universidade Federal de São Carlos

renatamendes@ufscar.br+5516988203291

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 3, 2026