Training Programme in Physical Activity

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).

Conditions

• Cardiovascular Risk Factor
• Cardiovascular Disease

Interventions

PROCEDURE

Training programme

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).

BEHAVIORAL

Educational talk

An educational talk given by the nurse and the physiotherapist about the components of a cardiosaluble lifestyle.

Sponsors & Collaborators

• Hospital Mutua de Terrassa

  lead OTHER

Principal Investigators

• Felicitas García Ortún, MD · Fundación Asistencial MutuaTerrassa

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-15

Primary Completion

2017-07-30

Completion

2017-11-30

Countries

• Spain

Study Locations