Training Programme in Physical Activity

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:
3. 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).
4. The overall PA measured with the total result obtained in the IPAQ-long version.
5. 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.
6. 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¨.
7. 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.