An observational study in Cardiovascular Diseases, Physical Inactivity and Aging, sponsored by Università degli Studi di Ferrara. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-10.
Sponsored by Università degli Studi di Ferrara · Observational
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.
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.
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This study's planned enrollment of 5,000 is above the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.
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male and female outpatients with stable cardiovascular disease involved in an exercise-based secondary prevention program.
Exclusion Criteria:
Patients with stable cardiovascular disease who have been referred to the service by their general practitioner or cardiologist
Other: Medical history and functional evaluation · Other: Health education
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.
Patients receive recommendations for risk factor management as well as continuous motivational counselling in order to develop and maintain a stable active lifestyle.
Mortality
Association of all-cause mortality and cause-specific death with exercise capacity
Time frame: 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
Hospitalization
Association of cause-specific hospitalization with exercise capacity
Time frame: 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)
Time frame: 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
Time frame: 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
Plan to share: Undecided
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