Training Programme in Physical Activity
Condition: Cardiovascular Risk Factor; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      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:

        1. 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.

        2. Secondary outcome variables: differences between groups in the change in:

             1. Physical exercise: quantitatively (measured by the sum of the results obtained in
                items 22-25 of the IPAQ-long version), frequency (Physical Activity Questionnaire
                for care consultations primary adapted to measure the frequency of physical
                exercise), and intention (Questionnaire of Stages of Change of Exercise
                (QSCE)-Short Form).

             2. Global physical activity (measured with the total result in the IPAQ-long version).

             3. Physical condition: ergometric variables (Peak Oxygen Consumption, exercise
                duration, anaerobic threshold moment)) and 6 Minute Walk Test.

        3. Other efficacy and safety variables: differences between groups in the changes in:

             1. Anthropometric variables.

             2. Blood pressure.

             3. Biochemical parameters.

             4. Mediterranean diet (simplified version of the questionnaire ¨Adherence to the
                Mediterranean Diet¨).

             5. Quality of life (questionnaire SF36-long version).

             6. Mood (Beck depression index).
    

Detailed 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:

        1. 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 .

        2. Secondary objectives: Determine the short, medium and long term efficacy in the primary
           care area of a supervised TP in:

             1. The practice of regular physical exercise, measured with items 22-25 of the
                IPAQ-long version, with the Short Physical Activity Questionnaire for Primary Care
                Consultations (PAQCCP) adapted to measure the frequency of exercise and with the
                Questionnaire of Stages of Change of Exercise-Short Form (QSCE-Short form).

             2. The overall PA measured with the total result obtained in the IPAQ-long version.

             3. The cardiorespiratory condition measured with the Six Minute Walking Test (6MWT)
                and the Cardiopulmonary Exercise Testing (CPET) variables Peak Oxygen Consumption
                (VO2peak), exercise duration and Anaerobic Threshold (AT) moment.

             4. The evolution of the main CVRF (smoking, body mass index, abdominal circumference,
                systolic and diastolic blood pressure, glycaemia, glycated haemoglobin, total
                cholesterol, high-density lipoprotein cholesterol (hdl-c), low-density lipoprotein
                cholesterol (ldl-c), triglycerides) and in the composition of the diet measure with
                the simplified version of the questionnaire ¨Adherence to the Mediterranean Diet¨.

             5. The quality of life quantified with the questionnaire SF36-long version and in the
                state of mind with the Beck Depression Index.

      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:

        -  An educational talk about CV risk, diet and cardio-healthy exercise, given by the nurse
           and the physiotherapist. The nurse gave the participant the information leaflet on
           heart-healthy lifestyles and administered the simplified version of the questionnaire
           ¨Adherence to the Mediterranean Diet¨ and the SF36 questionnaire-long version.

        -  Control visit by nurse, family doctor and rehabilitation doctor per month, at 6 months
           and 12 months post-TP (coinciding in time with 3, 8 and 14 months of the day of the
           educational talks common to the control group). In each visit the same variables were
           collected as in the initial assessment and also possible pharmacological changes,
           incidences, consultations with Cardiologist and medical tests performed.

      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:

        1. Variable main result: differences between groups in the percentage of participants that
           achieve an " Effective response in PA " defined by an increase in moderate-high PA
           measured with the sum of the results in the PA dimension moderate and vigorous PA
           dimension of the IPAQ-long version, of minimum 240 METs x min / wk.

        2. Secondary outcome variables: differences between groups in the changes in the amount of
           physical exercise measured by the sum of the results obtained in items 22-25 of the
           IPAQ-long version, in the frequency of physical exercise (PAQCCP adapted), and in the
           exercise intention (QSCE-Short form), changes in the global PA measured with the total
           result in the IPAQ-long version, change in the physical condition variables (ergometric
           variables (VO2peak, exercise duration, AT moment) and 6MWT).

        3. Other secondary variables: differences between groups in the changes in the analytical
           and anthropometric variables, in blood pressure, in the simplified version of the
           questionnaire ¨Adherence to the Mediterranean Diet¨, in the questionnaire SF36-long
           version and in the Beck Depression Index.

      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.
    

Intervention name(s): Training programme; Educational talk
Intervention type(s): Procedure; Behavioral
Intervention description(s): Training program in the primary care center supervised by a physiotherapist. The duration is two months and the frequency of sessions 3 times / week. Each session lasts 60 minutes.(30 minutes of aerobic exercise and 15 minutes of strength exercise).; An educational talk given by the nurse and the physiotherapist about the components of a cardiosaluble lifestyle.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomitzed interventional study with control group
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Training Programme; Physical Activity; cardiovascular primary prevention