Integrating Exercise Into Lifestyle of Cardiac Outpatients (ITER)

April 4, 2023 updated by: Giovanni Grazzi, MD, Università degli Studi di Ferrara

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Ferrara, Italy, 44123
        • Recruiting
        • Center for Exercise Science and Sport
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giovanni Grazzi, Professor
        • Sub-Investigator:
          • Gianni Mazzoni, Professor
        • Sub-Investigator:
          • Simona Mandini, PhD
        • Sub-Investigator:
          • Andrea Raisi, MSc
        • Sub-Investigator:
          • Tommaso Piva, MSc
        • Sub-Investigator:
          • Valentina Zerbini, MSc
        • Sub-Investigator:
          • Sabrina Masotti, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization
Time Frame: 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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 1997

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2047

Study Registration Dates

First Submitted

March 21, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSB-21-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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