Integrating Exercise Into Lifestyle of Cardiac Outpatients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversità degli Studi di Ferrara
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
the presence of one or more previous cardiovascular events
Disqualifiers
Ejection fraction < 30%
Chronic heart failure NYHA III-IV
Severe aortic or mitral valvulopathy
Severe physical or cognitive impairment
Trial population
male and female outpatients with stable cardiovascular disease involved in an exercise-based secondary prevention program.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Medical history and functional evaluation
Other interventionDuring 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.
Health education
Other interventionPatients receive recommendations for risk factor management as well as continuous motivational counselling in order to develop and maintain a stable active lifestyle.
Treatment groups
5,000 Participants
are divided into 1 treatment groupGroup A: Cardiac outpatients2 interventions
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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 years2
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 years3
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 yearsSponsors and contacts
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Source ClinicalTrials.gov