Integrating Exercise Into Lifestyle of Cardiac Outpatients

NCT05817305 | Recruiting DMC

• 1 other identifier: CSB-21-01
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Physical Inactivity; Aging; Quality of Life; Physician-Patient Relations

Keywords

Cardiovascular disease; Physical activity; Epidemiology; Cardiorespiratory fitness

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Hospitalization

  From date of enrollment until the first hospitalization (any hospital admission is considered an event), assessed up to 12 years

• 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

• 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

Study Arms (1)

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; Other: Health education

Interventions

Medical history and functional evaluation OTHER

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.

Cardiac outpatients

Health education OTHER

Patients receive recommendations for risk factor management as well as continuous motivational counselling in order to develop and maintain a stable active lifestyle.

Cardiac outpatients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

male and female outpatients with stable cardiovascular disease involved in an exercise-based secondary prevention program.

You may qualify if:

• the presence of one or more previous cardiovascular events

You may not qualify if:

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

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (1)

Center for Exercise Science and Sport

Ferrara, Ferrara, 44123, Italy

RECRUITING

Related Publications (18)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Grazzi G, Mazzoni G, Myers J, Codeca L, Pasanisi G, Napoli N, Guerzoni F, Volpato S, Conconi F, Chiaranda G. Improved walking speed is associated with lower hospitalisation rates in patients in an exercise-based secondary prevention programme. Heart. 2016 Dec 1;102(23):1902-1908. doi: 10.1136/heartjnl-2015-309126. Epub 2016 Jul 7.

  PMID: 27390367 BACKGROUND

• Uliari S, Myers J, Bernardi E, Chiaranda G, Conconi F, Terranova F, Mazzoni G, Grazzi G. Oxygen Uptake Attenuation at Ventilatory Threshold in Men With Coronary Artery Disease. J Cardiopulm Rehabil Prev. 2016 Jul-Aug;36(4):258-62. doi: 10.1097/HCR.0000000000000160.

  PMID: 27120036 BACKGROUND

• Mandini S, Grazzi G, Mazzoni G, Myers J, Pasanisi G, Sassone B, Conconi F, Chiaranda G. A moderate 1-km treadmill walk predicts mortality in men with mid-range left ventricular dysfunction. Eur J Prev Cardiol. 2017 Oct;24(15):1670-1672. doi: 10.1177/2047487317722434. Epub 2017 Jul 21. No abstract available.

  PMID: 28728484 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Grazzi G, Mazzoni G, Myers J, Codeca L, Pasanisi G, Mandini S, Piepoli M, Volpato S, Conconi F, Chiaranda G. Determining the best percent-predicted equation for estimated VO2 peak by a 1-km moderate perceptually-regulated treadmill walk to predict mortality in outpatients with cardiovascular disease. J Sci Med Sport. 2018 Mar;21(3):307-311. doi: 10.1016/j.jsams.2017.06.003. Epub 2017 Jun 8.

  PMID: 28645496 BACKGROUND

• Grazzi G, Mazzoni G, Myers J, Caruso L, Sassone B, Pasanisi G, Guerzoni F, Napoli N, Pizzolato M, Zerbini V, Franchi M, Masotti S, Mandini S, Raisi A, Chiaranda G. Impact of Improvement in Walking Speed on Hospitalization and Mortality in Females with Cardiovascular Disease. J Clin Med. 2020 Jun 5;9(6):1755. doi: 10.3390/jcm9061755.

  PMID: 32517001 BACKGROUND

• 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 BACKGROUND

• Bonnini S, Mazzoni G, Borghesi M, Chiaranda G, Myers J, Mandini S, Raisi A, Masotti S, Grazzi G. Improving walking speed reduces hospitalization costs in outpatients with cardiovascular disease. An analysis based on a multistrata non-parametric test. BMC Health Serv Res. 2020 Nov 17;20(1):1048. doi: 10.1186/s12913-020-05874-3.

  PMID: 33203408 BACKGROUND

• Chiaranda G, Myers J, Arena R, Kaminsky L, Sassone B, Pasanisi G, Mandini S, Mazzoni G, Grazzi G. Prognostic comparison of the FRIEND and Wasserman/Hansen peak VO2 equations applied to a submaximal walking test in outpatients with cardiovascular disease. Eur J Prev Cardiol. 2021 Apr 23;28(3):287-292. doi: 10.1177/2047487319871728. Epub 2019 Aug 26.

  PMID: 33891689 BACKGROUND

• 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 BACKGROUND

• Raisi A, Zerbini V, Myers J, Masotti S, Piva T, Lordi R, Chiaranda G, Grazzi G, Mazzoni G, Mandini S. Moderate walking speed and survival association across 23-years follow-up in female patients with cardiovascular disease. Int J Cardiol. 2023 Jan 15;371:371-376. doi: 10.1016/j.ijcard.2022.09.014. Epub 2022 Sep 9.

  PMID: 36089160 BACKGROUND

• Raisi A, Piva T, Myers J, Lordi R, Zerbini V, Masotti S, Chiaranda G, Grazzi G, Mazzoni G, Mandini S. A Moderate Walking Test Predicts Survival in Women With Cardiovascular Disease. Am J Prev Med. 2023 Sep;65(3):497-504. doi: 10.1016/j.amepre.2023.02.025. Epub 2023 Mar 5.

  PMID: 36871638 BACKGROUND

• Raisi A, Bernardi E, Myers J, Piva T, Zerbini V, Masotti S, Menegatti E, Caruso L, Mazzoni G, Grazzi G, Mandini S. Change in Peak Oxygen Uptake Predicted by the Moderate 1-km Treadmill Walking Test After Walking Training in Outpatients With Cardiovascular Disease. J Cardiopulm Rehabil Prev. 2024 Mar 1;44(2):131-136. doi: 10.1097/HCR.0000000000000812. Epub 2023 Aug 25.

  PMID: 37616588 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Sedentary Behavior; Motor Activity

Interventions

Health Records, Personal

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques

Study Officials

• Gianni Mazzoni, Professor

  Università degli Studi di Ferrara

  STUDY DIRECTOR

• Giovanni Grazzi, Professor

  Università degli Studi di Ferrara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Grazzi, Professor

CONTACT

+39 0535455963; giovanni.grazzi@unife.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 18, 2023
• Study Start: January 1, 1997
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2047
• Last Updated: April 10, 2025

Record last verified: 2024-05

Locations

IT (1)