Training Programme in Physical Activity

NCT03717363 | Completed

• 1 other identifier: A2_2014
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

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. 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. 2.Secondary outcome variables: differences between groups in the change in:
3. 3.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).
4. 4.Global physical activity (measured with the total result in the IPAQ-long version).
5. 5.Physical condition: ergometric variables (Peak Oxygen Consumption, exercise duration, anaerobic threshold moment)) and 6 Minute Walk Test.
6. 6.Other efficacy and safety variables: differences between groups in the changes in:
7. 7.Anthropometric variables.
8. 8.Blood pressure.
9. 9.Biochemical parameters.
10. 10.Mediterranean diet (simplified version of the questionnaire ¨Adherence to the Mediterranean Diet¨).
11. 11.Quality of life (questionnaire SF36-long version).
12. 12.Mood (Beck depression index).

Conditions

Cardiovascular Risk Factor; Cardiovascular Disease

Keywords

Training Programme; Physical Activity; cardiovascular primary prevention

Outcome Measures

Primary Outcomes (1)

• Difference between groups in the proportion of patients who achieve the ¨Effective response in Physical Activity¨

  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.

  1 month post intervention; 6 months post intervention and 12 months post intervention

Study Arms (2)

Control group

ACTIVE COMPARATOR

Educational talk: an educational talk given by the nurse and the physiotherapist about the components of a cardiosaluble lifestyle.

Behavioral: Educational talk

Interventional group

EXPERIMENTAL

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; Behavioral: Educational talk

Interventions

Training programme PROCEDURE

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).

Interventional group

Educational talk BEHAVIORAL

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

Control group; Interventional group

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Mutua de Terrassa: lead

Study Sites (1)

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Related Publications (4)

• Boule NG, Kenny GP, Haddad E, Wells GA, Sigal RJ. Meta-analysis of the effect of structured exercise training on cardiorespiratory fitness in Type 2 diabetes mellitus. Diabetologia. 2003 Aug;46(8):1071-81. doi: 10.1007/s00125-003-1160-2. Epub 2003 Jul 10.

  PMID: 12856082 BACKGROUND

• Eriksson KM, Westborg CJ, Eliasson MC. A randomized trial of lifestyle intervention in primary healthcare for the modification of cardiovascular risk factors. Scand J Public Health. 2006;34(5):453-61. doi: 10.1080/14034940500489826.

  PMID: 16990155 RESULT

• Balducci S, Zanuso S, Nicolucci A, De Feo P, Cavallo S, Cardelli P, Fallucca S, Alessi E, Fallucca F, Pugliese G; Italian Diabetes Exercise Study (IDES) Investigators. Effect of an intensive exercise intervention strategy on modifiable cardiovascular risk factors in subjects with type 2 diabetes mellitus: a randomized controlled trial: the Italian Diabetes and Exercise Study (IDES). Arch Intern Med. 2010 Nov 8;170(20):1794-803. doi: 10.1001/archinternmed.2010.380.

  PMID: 21059972 RESULT

• Garcia-Ortun F, Jaen A, Sola L, Gonzalez-Gil L, Garreta R, de la Sierra A. Physical training program for people at risk of cardiovascular disorders in the primary care setting: A randomized clinical trial. Med Clin (Barc). 2022 Nov 25;159(10):475-482. doi: 10.1016/j.medcli.2022.01.020. Epub 2022 Mar 19. English, Spanish.

  PMID: 35318946 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Felicitas García Ortún, MD

  Fundación Asistencial MutuaTerrassa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. Head of cardio-respiratory rehabilitation unit.

Model Details: randomitzed interventional study with control group

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 24, 2018
• Study Start: October 15, 2014
• Primary Completion: July 30, 2017
• Study Completion: November 30, 2017
• Last Updated: October 26, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)