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The primary prevention of cardiovascular disease is an unresolved health problem. A sedentary lifestyle and a low cardiorespiratory condition both increase the risk of cardiovascular disease, at a similar extent as that promoted by traditional risk factors, such as smoking, high blood pressure or dyslipidemia. The scientific evidence regarding the effect of the promotion of an active lifestyle on primary cardiovascular prevention is limited. Several studies have shown that structured training programs (TP) are effective at short term, but at the medium or long term their efficacy is still unknown. There are very few randomized controlled trials, and there are almost no studies conducted in the primary care setting which analyze the long-term effects of this type of program on primary cardiovascular prevention. The investigators performed in primary care a previous quasi-experimental study without control group demonstrating the short-term effectiveness in the improvements of both physical condition and in the practice of physical exercise of this TP, the shortest so far analyzed in primary care. With the current study the investigators also want to demonstrate its short-term efficacy in the promotion of moderate-high physical activity and in the practice of physical exercise, through a high-evidence design such as a randomized clinical trial with a control group, also the extension of such efficacy in the medium and long term.
Objective:
To determine the efficacy of a supervised 2 month TP on short-term (1 month post-TP), medium-term (6 months post-TP) and long-term (12 months post-TP) promotion of moderate-high physical activity and practice of physical exercise, in a sedentary population with high cardiovascular risk, attending primary care centres.
Methodology:
A parallel, randomized, intervention study, with a control group. Inclusion criteria: Men and women of an age between 35 and 70 years, attending a primary care center in hospital reference area, with high cardiovascular risk. Sedentary lifestyle defined by a score <2 in the brief Physical Activity Questionnaire for care consultations primary adapted to measure the frequency of physical exercise and with a total result in the International Physical Activity Questionnaire (IPAQ)-long version ≤1500 METs x minutes/week, who agree to participate and commit to compliance with the program.
Participants were randomized (automated list generation) to a control group, consisting in conventional management or to an intervention group (TP 2 months, 3 times / week). Both groups received an educational talk about cardiovascular risk, healthy diet habits and cardio-healthy exercise at the beginning of TP. Assessments were performed at baseline, and at 3, 8 and 14 months.
OUTCOMES:
Main outcome measure: differences between groups in the proportion of participants with an "Effective response in Physical Activity ". This effective response was considered if there was an increase ≥ 240 METs x minutes / week in the moderate-high physical activity (measured by IPAQ-long version) in the final evaluation.
Secondary outcome variables: differences between groups in the change in:
Other efficacy and safety variables: differences between groups in the changes in:
Full description
INTRODUCTION The primary prevention of cardiovascular disease (CVD), the main cause of morbidity and mortality in most Western countries, is a priority. A sedentary lifestyle and a low cardiorespiratory condition increase the risk of CVD with the same impact as the presence of Cardiovascular Risk Factors (CVRF) such as smoking, high blood pressure or dyslipidemia.
Among the interventions aimed at promoting Physical Activity (PA), there are supervised Training Programs (TP). In Primary Cardiovascular Prevention (PCVP), supervised TP appear to be effective in the short term in improving cardiorespiratory fitness, glycemic control, cardiovascular (CV) risk profile and in promoting a more active lifestyle. The effect of these TPs in the medium-long term in PCVP is still unknown. In primary care, the ideal context in which to apply interventions aimed at the promotion of a cardio-healthy lifestyle, the few randomized controlled trials (RCT) conducted on the effects of this type of interventions in the medium-long term obtain contradictory results.
The investigators aims to analyze the short, medium and long term efficacy of a supervised TP, performed in primary care and with the shortest duration so far contemplated (2 months), in the promotion of moderate-high PA and in practice of physical exercise, in a sedentary population with high CV risk.
OBJECTIVES:
Main objective: To determine the short, medium and long term efficacy in the field of primary care of a supervised TP in the promotion of moderate-high PA, measured with the variable " Effective response in PA " that is defined as an increase in moderate-high PA (measured by the sum of the results in the moderate PA dimension and vigorous PA dimension of the International Physical Activity Questionnaire (IPAQ)-long version of at least 240 METs x minute/week (METs x min/wk), in a sedentary population with high CV risk .
Secondary objectives: Determine the short, medium and long term efficacy in the primary care area of a supervised TP in:
METHODOLOGY
DESIGN: Randomized controlled trial.
SUBJECTS, SCOPE AND CRITERIA FOR INCLUSION TO THE STUDY: Participants aged 35 to 70 years old from the ¨Rambla¨ primary care center in the reference area of the Mutua Terrassa University Hospital, sedentary and with high CV risk who agreed to participate and were committed to a fulfillment of the program.
Sedentary was considered one with a score in the PAQCCP (Puig A et al., Aten Primaria 2012; 44 (8): 485-93), adapted to measure the frequency of physical exercise, less than 2 and with a result in the total IPAQ-long version ≤1500 METs x min /wk.
The high CV risk was defined by the presence of any of the following conditions: Diabetes Mellitus type 2; Metabolic syndrome, defined by the criteria of the National Cholesterol Education Program (NCEP) / American Heart Association (AHA); and / or Hypertension with at least one associated CVRF (smoking, dyslipidemia, obesity).
EXCLUSION CRITERIA: Last ambulatory visit performed in a period greater than one year at the time of inclusion, pregnant women, comorbidities that prevent the patient from doing the TP, not autonomy for a commitment to program compliance and / or previous CV events.
STUDY PERIOD: after the inclusion period and the completion of an educational talk, the participants were followed a total of 14 months. The total duration of the study was 36 months to complete all the groups and their follow-up.
SAMPLING AND TOTAL SIZE:
Accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, 73 participants in the control group and 73 in the intervention group were required to detect a clinically relevant difference between groups of at least 20% in the proportion of participants with "Effective response in PA". This response has been defined as the increase in the moderate-high PA measured with the sum of the results in the moderate PA dimension and vigorous PA dimension of the IPAQ-long version, of minimum 240 METs x min /wk. A proportion of responding participants was assumed in PA of 11% in the control group and 31% in the intervention group. A follow-up loss rate of 15% was estimated. The ARCOSENO approach was used.
Sampling was carried out by a simple randomization in an automated way, assigning to the participants an identifier number corresponding to the control or intervention group.
PROCEDURE, INSTRUMENTATION AND COLLECTION OF INFORMATION:
The family doctor of the primary care center made a first selection of candidates. After receiving all the necessary information about the study and signing the informed consent, the family doctor referred participants to the rehabilitation doctor. In the initial assessment of the rehabilitation doctor a socio-demographic, anthropometric, analytical variables (haemoglobin, lipid profile, glycemia, glycated haemoglobin and creatinine), systolic and basal diastolic blood pressure, baseline heart rate, pathological history and CVRF and pharmacological treatment were collected. In addition, the PAQCCP, the QSCE-Short Form, the IPAQ-long version and the Beck Depression Index. All the questionnaires used in the study were translated and validated into Spanish. 6MWT and CPET were performed. If the CPET was clinically and /or electrically positive, the participants was not included in the study until it was assessed by the Cardiologist of the program, and the latter would rule out the presence of established CVD. After the assessment, the inclusion in the study of the selected participants was confirmed and they were assigned to the control group or intervention group as it corresponded to the automated randomization.
If the participant was assigned to the intervention group he received the following attention:
If the participant was assigned to the control group, he received the same attention as the intervention group except that he did not perform the TP. The controls by nursing, family doctor and rehabilitation doctor were carried out at 3, 8 and 14 months of the day of the educational talks.
An action protocol was followed for the control group and for the intervention group, so that in the event that during the follow-up the CPET was clinically and / or electrically positive, it was evaluated by the Cardiologist and if established CVD was confirmed, the participant left the study.
VARIABLES:
DATA ANALYSIS:
After collecting the variables, the data has been entered into a relational Access database designed ad-hoc.
At this moment the debugging, consistency and quality control of the data are being carried out, together with the first statistical analyzes at the post-program month (3 months post-talks) through the Stata vs 13.0 program.
The comparison of results between control group and intervention group will be made at 3, 8 and 14 months of the day of the talks.
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147 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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