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Training Programme in Physical Activity

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ClinicalTrials.gov Identifier: NCT03717363
Recruitment Status : Completed
First Posted : October 24, 2018
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Felicitas Garcia, Hospital Mutua de Terrassa

Brief 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).

Condition or disease Intervention/treatment Phase
Cardiovascular Risk Factor Cardiovascular Disease Procedure: Training programme Behavioral: Educational talk Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomitzed interventional study with control group
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of Training Programme in Physical Activity Promotion in Patients With High Risk of Cardiovascular Disease
Actual Study Start Date : October 15, 2014
Actual Primary Completion Date : July 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control group
Educational talk: an educational talk given by the nurse and the physiotherapist about the components of a cardiosaluble lifestyle.
Behavioral: Educational talk
An educational talk given by the nurse and the physiotherapist about the components of a cardiosaluble lifestyle.

Experimental: Interventional group
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).
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.




Primary Outcome Measures :
  1. Difference between groups in the proportion of patients who achieve the ¨Effective response in Physical Activity¨ [ Time Frame: 1 month post intervention; 6 months post intervention and 12 months post intervention ]

    The ¨Effective response in Physical Activity¨ is defined as an minimum increase of 240 METsxmin / wk in moderate-vigorous Physical Activity measured with the sum of the results in the moderate and vigorous Physical Activity dimension of the International Physical Activity Questionnaire-Long version.

    The International Physical Activity Questionnaire- long version (27 items) collects data in different domains and intensities (moderate, vigorous,walking) and includes sitting time. The units of measurement are METsxmin/week. The amount of physical activity is recorded by intensity (moderate, vigorous, walking) and the amount of total physical activity obtained by adding the records in each dimension according to intensity . A category of low physical activity is considered a result in the total physical activity below 600 METsxmin / week, moderate between 600 and 3000 METsxmin / week and high above 3000 MEtsxmin / week.




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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • From a primary care center in the reference area of our hospital
  • High cardiovascular risk
  • Sedentary defined by a score in the brief Physical Activity Questionnaire for primary care consultations (CAFBCAP) adapted for measure the frequency of physical exercise <2 and with a result in the IPAQ-total long version ≤1500 METsxmin / week
  • they accept to participate and commit to compliance with the program.

Exclusion Criteria:

  • Last ambulatory visit more than a year ago
  • Pregnant women
  • Comorbidities that make the patient unable to do the programme or to be dependen on second person for journeys
  • Previous cardiovascular events.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717363


Locations
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Spain
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, Spain, 08221
Sponsors and Collaborators
Hospital Mutua de Terrassa
Investigators
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Principal Investigator: Felicitas García Ortún, MD Fundación Asistencial MutuaTerrassa

Publications of Results:
Other Publications:
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Responsible Party: Felicitas Garcia, Principal Investigator. Head of cardio-respiratory rehabilitation unit., Hospital Mutua de Terrassa
ClinicalTrials.gov Identifier: NCT03717363    
Other Study ID Numbers: A2_2014
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Felicitas Garcia, Hospital Mutua de Terrassa:
Training Programme
Physical Activity
cardiovascular primary prevention
Additional relevant MeSH terms:
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Cardiovascular Diseases