Integrating Exercise Into Lifestyle of Cardiac Outpatients

Official title

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

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

• Mortality [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]

Secondary outcome measures (3)

• Hospitalization [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) [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 [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]

Eligibility criteria

Inclusion criteria

• the presence of one or more previous cardiovascular events

Exclusion criteria

• Ejection fraction < 30%
• Chronic heart failure NYHA III-IV
• Severe aortic or mitral valvulopathy
• Severe physical or cognitive impairment
• Exercise-induced complex arrhythmias

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Italy · 1 center

• Center for Exercise Science and Sport — Ferrara

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. PMID 22936157
• 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. PMID 28671933
• 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. PMID 29661150
• 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. PMID 28967238
• 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. PMID 32438791
• 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. PMID 34727562
• Chiaranda G, Bernardi E, Codeca L, Conconi F, Myers J, Terranova F, Volpato S, Mazzoni G, Grazzi G. Treadmill walking speed and survival prediction in men with cardiovascular disease: a 10-year follow-up study. BMJ Open. 2013 Oct 25;3(10):e003446. doi: 10.1136/bmjopen-2013-003446. PMID 24163203
• Grazzi G, Myers J, Bernardi E, Terranova F, Grossi G, Codeca L, Volpato S, Conconi F, Mazzoni G, Chiaranda G. Association between VO(2) peak estimated by a 1-km treadmill walk and mortality. A 10-year follow-up study in patients with cardiovascular disease. Int J Cardiol. 2014 May 1;173(2):248-52. doi: 10.1016/j.ijcard.2014.02.039. Epub 2014 Feb 28. PMID 24630380

Identifiers

NCT: NCT05817305 · CSB-21-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗