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O estudo clínico NCT05817305 (ITER) para Doenças cardiovasculares, Inatividade física, Envelhecimento, Qualidade de Vida, Relações médico-paciente está recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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Integrating Exercise Into Lifestyle of Cardiac Outpatients (ITER)

Recrutando
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT05817305 (ITER) é um ensaio observacional para Doenças cardiovasculares, Inatividade física, Envelhecimento, Qualidade de Vida, Relações médico-paciente. Seu status atual é: recrutando. O estudo começou em 1 de janeiro de 1997 e pretende incluir 5.000 participantes. Coordenado por Università degli Studi di Ferrara e deve ser concluído em 31 de dezembro de 2047. Essas informações foram atualizadas no ClinicalTrials.gov em 10 de abril de 2025.
Resumo
The purpose of the study is to investigate the long-term effects of a personalized physical activity program on exercise capacity and quality of life in patients with stable cardiovascular disease. The analysis also intends to evaluate the prognostic value of cardiovascular function estimated through a walking test (1km Treadmill Walking Test, 1k-TWT) in relation to survival, hospitalization, and medical costs. The program considers clinical, socio-economic, and behavioural aspects, psychological support, and risk factor control. Patients receive indications for carrying out a home training program based on the performance of moderate-intensity aerobic activity at least 3-4 days a week for at least 30-60 minutes a day. All patients are also encouraged to improve their daily habits by preferring a more active lifestyle both at home and at work.
Descrição detalhada
BACKGROUND: Physical activity and cardiorespiratory fitness are considered major markers of cardiovascular risk and core components of secondary prevention programs for cardiovascular diseases (CVD). The benefits of regular physical activity are well-recognized both for men and women and are inversely associated with mortality risk and the incidence of many chronic diseases. Despite the efforts of many health organizations to increase awareness of this evidence, physical inactivity and low cardiorespiratory fitness remain overlooked risk factors. Directly measured peak oxygen consumption (VO2peak) determined during maximal incremental cardiopulmonary exercise testing (CPX) is the gold standard objective measure of cardiorespiratory fitness. However, because of physical, financial, and time limitations, a direct determination is often not routinely assessed in clinical settings. Submaximal exercise testing can be a viable alternative to CPX. These tests are more practical for examining older adults or a large patient cohort. Also, they are helpful in defining functional limitations, setting up appropriate physical activity programs, and assessing the outcomes of pharmacological treatments.

RATIONALE AND OBJECTIVE OF THE STUDY: The benefits of regular physical activity are well-recognized both for men and women and are inversely associated with mortality risk and the incidence of many chronic diseases. The purpose of this observational registry is to evaluate the efficacy of an exercise-based secondary prevention program among male and female outpatients with stable cardiovascular disease.

DESCRIPTION OF THE FUNCTIONAL EVALUATION: During each session, information about weight, height, body mass index (BMI), blood pressure, cardiometabolic risk factors, and drug therapy in progress are registered. Physical activity habits are assessed using the Seven-Day Physical Activity Recall questionnaire. In addition, patients complete a sub-maximal test of 1km treadmill walking (1k-TWT), which is performed at a moderate intensity and adjusted according to the patient's perception of fatigue. Patients unable to complete the test at a walking speed ≥ 3.0 km/h can perform the test over 500m or 200m. Based on the results of the test, patients receive indications for the proper execution of a home training program, (i.e., at the same effort perceived in the test). The activity should be done at least 3-4 times per week, preferably every day, for at least 30-60 minutes. All patients are also encouraged to improve their daily habits by opting for a more active lifestyle at home and at work. Written informed consent is required from all participants at the time of enrollment.

Título oficial

Efficacy of an Exercise-based Secondary Prevention Program in Patients With Stable Cardiovascular Disease

Condições
Doenças cardiovascularesInatividade físicaEnvelhecimentoQualidade de VidaRelações médico-paciente
Publicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:
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Outros IDs do estudo
  • ITER
  • CSB-21-01
Número NCT
Data de início (real)
1997-01-01
Última atualização postada
2025-04-10
Data de conclusão (estimada)
2047-12-31
Inscrição (estimada)
5.000
Tipo de estudo
Observacional
Status
Recrutando
Palavras-chave
Cardiovascular disease
Physical activity
Epidemiology
Cardiorespiratory fitness
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
Cardiac outpatients
Patients with stable cardiovascular disease who have been referred to the service by their general practitioner or cardiologist
Medical History and Functional Evaluation
During each session, physical parameters are measured and data on medical history and physical activity are collected. To assess cardiorespiratory fitness, all patients complete a submaximal, moderate, and perceptually regulated treadmill walking test (1k-TWT). Patients unable to complete the test at a walking speed ≥ 3.0 km/h perform the test over 500m or 200m.
Educação em saúde
Patients receive recommendations for risk factor management as well as continuous motivational counselling in order to develop and maintain a stable active lifestyle.
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Mortality
Association of all-cause mortality and cause-specific death with exercise capacity
From date of enrollment until the date of end of follow-up or date of death from any cause, whichever came first, assessed up to 12 years
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
Hospitalization
Association of cause-specific hospitalization with exercise capacity
From date of enrollment until the first hospitalization (any hospital admission is considered an event), assessed up to 12 years
Peak Oxygen Uptake (VO2peak)
Measurement of cardiorespiratory fitness, reported as ml/kg/min and estimated through a moderate and perceptually regulated 1km treadmill walk test (1k-TWT) or through related short-forms (500m or 200m)
From date of enrollment until the date of end of follow-up or date of death from any cause, whichever came first, assessed up to 12 years
Leisure time physical activity levels
Measurement of physical activity levels, reported as MET/h-week and estimated through the 7-day physical activity recall questionnaire
From date of enrollment until the date of end of follow-up or date of death from any cause, whichever came first, assessed up to 12 years
Critérios de elegibilidade

Idades elegíveis
Adulto, Adulto mais velho
Idade mínima
18 Years
Sexos elegíveis
Todos
Aceita voluntários saudáveis
Sim
  • the presence of one or more previous cardiovascular events

  • Ejection fraction < 30%
  • Chronic heart failure NYHA III-IV
  • Severe aortic or mitral valvulopathy
  • Severe physical or cognitive impairment
  • Exercise-induced complex arrhythmias
Università degli Studi di Ferrara logoUniversità degli Studi di Ferrara
Responsável pelo estudo
Giovanni Grazzi, MD, Investigador principal, Professor, Università degli Studi di Ferrara
Contato central do estudo
Contato: Giovanni Grazzi, Professor, +39 0535455963, [email protected]
1 Locais do estudo em 1 países

Ferrara

Center for Exercise Science and Sport, Ferrara, Ferrara, 44123, Italy
Giovanni Grazzi, Professor, Contato, +39 0535455963, [email protected]
Andrea Raisi, MSc, Contato, +39 0535455963, [email protected]
Giovanni Grazzi, Professor, Investigador principal
Gianni Mazzoni, Professor, Subinvestigador
Simona Mandini, PhD, Subinvestigador
Andrea Raisi, MSc, Subinvestigador
Tommaso Piva, MSc, Subinvestigador
Valentina Zerbini, MSc, Subinvestigador
Sabrina Masotti, PhD, Subinvestigador
Recrutando