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Lo studio clinico NCT05817305 (ITER) per Malattie cardiovascolari, Inattività fisica, Invecchiamento, Qualità della vita, Relazioni medico-paziente è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Integrating Exercise Into Lifestyle of Cardiac Outpatients (ITER)

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT05817305 (ITER) è uno studio osservazionale per Malattie cardiovascolari, Inattività fisica, Invecchiamento, Qualità della vita, Relazioni medico-paziente, attualmente in arruolamento. Avviato il 1 gennaio 1997, prevede di arruolare 5.000 partecipanti. Sotto la guida di Università degli Studi di Ferrara, dovrebbe concludersi entro il 31 dicembre 2047. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 10 aprile 2025.
Sommario breve
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.
Descrizione dettagliata
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.

Titolo ufficiale

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

Condizioni
Malattie cardiovascolariInattività fisicaInvecchiamentoQualità della vitaRelazioni medico-paziente
Pubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:
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Altri ID dello studio
  • ITER
  • CSB-21-01
Numero NCT
Data di inizio (effettiva)
1997-01-01
Ultimo aggiornamento pubblicato
2025-04-10
Data di completamento (stimata)
2047-12-31
Arruolamento (previsto)
5.000
Tipo di studio
Osservazionale
Stato
In arruolamento
Parole chiave
Cardiovascular disease
Physical activity
Epidemiology
Cardiorespiratory fitness
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
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.
Educazione sanitaria
Patients receive recommendations for risk factor management as well as continuous motivational counselling in order to develop and maintain a stable active lifestyle.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
Accetta volontari sani
  • 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
Parte responsabile dello studio
Giovanni Grazzi, MD, Investigatore principale, Professor, Università degli Studi di Ferrara
Contatti principali dello studio
Contatto: Giovanni Grazzi, Professor, +39 0535455963, [email protected]
1 Centri dello studio in 1 paesi

Ferrara

Center for Exercise Science and Sport, Ferrara, Ferrara, 44123, Italy
Giovanni Grazzi, Professor, Contatto, +39 0535455963, [email protected]
Andrea Raisi, MSc, Contatto, +39 0535455963, [email protected]
Giovanni Grazzi, Professor, Investigatore principale
Gianni Mazzoni, Professor, Sub-investigatore
Simona Mandini, PhD, Sub-investigatore
Andrea Raisi, MSc, Sub-investigatore
Tommaso Piva, MSc, Sub-investigatore
Valentina Zerbini, MSc, Sub-investigatore
Sabrina Masotti, PhD, Sub-investigatore
In arruolamento