ITER: Integrating Exercise Into Lifestyle of Cardiac Outpatients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cardiac outpatients Patients with stable cardiovascular disease who have been referred to the service by their general practitioner or cardiologist |
Other: 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.
Other: Health education
Patients receive recommendations for risk factor management as well as continuous motivational counselling in order to develop and maintain a stable active lifestyle.
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Outcome Measures
Primary Outcome Measures
- Mortality [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]
Association of all-cause mortality and cause-specific death with exercise capacity
Secondary Outcome Measures
- Hospitalization [From date of enrollment until the first hospitalization (any hospital admission is considered an event), assessed up to 12 years]
Association of cause-specific hospitalization with exercise capacity
- Peak Oxygen Uptake (VO2peak) [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]
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)
- Leisure time physical activity levels [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]
Measurement of physical activity levels, reported as MET/h-week and estimated through the 7-day physical activity recall questionnaire
Eligibility Criteria
Criteria
Inclusion Criteria:
- the presence of one or more previous cardiovascular events
Exclusion Criteria:
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Ejection fraction < 30%
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Chronic heart failure NYHA III-IV
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Severe aortic or mitral valvulopathy
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Severe physical or cognitive impairment
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Exercise-induced complex arrhythmias
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for Exercise Science and Sport | Ferrara | Italy | 44123 |
Sponsors and Collaborators
- Università degli Studi di Ferrara
Investigators
- Study Director: Gianni Mazzoni, Professor, Università degli Studi di Ferrara
- Principal Investigator: Giovanni Grazzi, Professor, Università degli Studi di Ferrara
Study Documents (Full-Text)
None provided.More Information
Publications
- Chiaranda G, Myers J, Mazzoni G, Terranova F, Bernardi E, Grossi G, Codeca L, Conconi F, Grazzi G. Peak oxygen uptake prediction from a moderate, perceptually regulated, 1-km treadmill walk in male cardiac patients. J Cardiopulm Rehabil Prev. 2012 Sep-Oct;32(5):262-9. doi: 10.1097/HCR.0b013e3182663507.
- Grazzi G, Chiaranda G, Myers J, Pasanisi G, Lordi R, Conconi F, Mazzoni G. Outdoor Reproducibility of a 1-km Treadmill Walking Test to Predict Peak Oxygen Uptake in Cardiac Patients. J Cardiopulm Rehabil Prev. 2017 Sep;37(5):347-349. doi: 10.1097/HCR.0000000000000266.
- Mazzoni G, Chiaranda G, Myers J, Sassone B, Pasanisi G, Mandini S, Volpato S, Conconi F, Grazzi G. 500-meter and 1000-meter moderate walks equally assess cardiorespiratory fitness in male outpatients with cardiovascular diseases. J Sports Med Phys Fitness. 2018 Sep;58(9):1312-1317. doi: 10.23736/S0022-4707.17.07525-9. Epub 2017 Sep 29.
- Mazzoni G, Myers J, Sassone B, Pasanisi G, Mandini S, Raisi A, Pizzolato M, Franchi M, Caruso L, Missiroli L, Chiaranda G, Grazzi G. A moderate 200-m walk test estimates peak oxygen uptake in elderly outpatients with cardiovascular disease. J Sports Med Phys Fitness. 2020 May;60(5):786-793. doi: 10.23736/S0022-4707.20.10387-6.
- Mazzoni G, Sassone B, Pasanisi G, Myers J, Mandini S, Volpato S, Conconi F, Chiaranda G, Grazzi G. A moderate 500-m treadmill walk for estimating peak oxygen uptake in men with NYHA class I-II heart failure and reduced left ventricular ejection fraction. BMC Cardiovasc Disord. 2018 Apr 16;18(1):67. doi: 10.1186/s12872-018-0801-9.
- Zerbini V, Raisi A, Myers J, Piva T, Lordi R, Chiaranda G, Mazzoni G, Grazzi G, Mandini S. Peak Oxygen Uptake Estimation From A Moderate 1-KM Treadmill Walk in Women With Cardiovascular Disease. J Cardiopulm Rehabil Prev. 2021 Nov 1;41(6):432-434. doi: 10.1097/HCR.0000000000000641. No abstract available.
- CSB-21-01