Condition category
Circulatory System
Date applied
21/11/2014
Date assigned
08/04/2015
Last edited
06/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The recommended level of physical activity for adults is at least 150 minutes of moderate-intensity aerobic physical activity throughout the week. The goal of this study is to find out whether a new strategy in the prescription of physical exercise helps more patients to follow this recommendation.

Who can participate?
The study aims to recruit about 616 adult primary care patients with a moderate to high cardiovascular risk.

What does the study involve?
Patients will be randomly allocated to either the control or the intervention group. Patients in the intervention group will be invited to attend a first visit (35 minutes) where his/her nurse/general practitioner will explore their motivation to practice physical exercise and in those patients who are ready, the patient and clinician will agree the amount and type of physical exercise to do. For those patients who are not ready to exercise, the clinician can explore their reasons and trying to motivate the patient to be ready to exercise in the next visits. Four visits for patients from the intervention group are planned in a one-year period.

What are the possible benefits and risks of participating?
The immediate direct benefit to those taking part are improvements in sleep quality, mood and self-esteem; it can also reduce your risk of major illnesses, such as heart disease, stroke, diabetes and cancer by up to 50% and lower your risk of early death by up to 30%. There is no risk if the intensity of the exercise is moderate.

Where is the study run from?
The study has been set up by the University of the Balearic Islands in collaboration with Primary Care and General Direction of Public Health of the Balearic Islands (Spain).

When is the study starting and how long is it expected to run for?
It is anticipated that recruitment will start in January 2015. Participants will be enrolled on the study for a period of 2 years.

Who is funding the study?
Funding has been provided by the Institute of Health Carlos III (Spain).

Who is the main contact?
Professor Antoni Aguiló, aaguilo@uib.es
Mr Alfonso Leiva, aleiva@ibsalut.caib.es

Trial website

Contact information

Type

Public

Primary contact

Mr Aina Riera

ORCID ID

Contact details

Departament d'Infermeria i Fisioteràpia
Universitat de les Illes Balears. Cra. de Valldemossa
km 7.5
Palma (Illes Balears)
07122.
Spain
+34 (0) 971 17 30 00
ana.riera@uib.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PI13/01477

Study information

Scientific title

To evaluate the effectiveness of a brief multifactorial intervention designed to improve the adherence to physical exercise prescription of moderate to high cardiovascular risk patients

Acronym

Study hypothesis

Current hypothesis as of 06/07/2015:
A brief multifactorial intervention based on a motivational interview, the transtheoretical stages of changes of Prochaska and Diclemente, and a individualized prescription of physical exercise (patients will choose from several activities that can be adapted to their day to day living) improves adherence to the minimum recommended physical activity (150 minute per week) by 7.8% in the absolute percentage in patients with at least two cardiovascular risk factors and with a cardiovascular risk up to 15% measured using the Framingham-Regicor equation.

Previous hypothesis:
A brief multifactorial intervention based on a motivational interview, the transtheoretical stages of changes of Prochaska and Diclemente, and a individualized prescription of physical exercise (patients could choose from 10 activities that can be adapted to their day to day living) improves adherence to the minimum recommended physical activity (150 minute per week) by 8.8% in the absolute percentage in moderate to high cardiovascular risk patients.

On 06/07/2015 the study design was changed from 'Two-arm multicenter cluster randomized clinical trial' to 'Two-arm multicenter randomized clinical trial'.

Ethics approval

Ballearic Island Ethics Committee, 11/06/2014, 23/41/14PI

Study design

Two-arm multicenter randomized clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Condition

Patient with a cardiovascular risk between 5 and15% in the REGICOR score

Intervention

Individualized physical exercise and patient-orientated counselling on written prescription referred to formal or informal resources localized in the healthcare centre area

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Exercise practice of 150 min/week measured by IPAQ (International Physical Activity Questionnaire) questionnaire at 12 months

Secondary outcome measures

Exercise practice (METs x min x week) measured by IPAQ (International Physical Activity Questionnaire) questionnaire at 12 months

Overall trial start date

12/06/2014

Overall trial end date

12/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 06/07/2015:
1. Patients aged 35-75 years
2. Patients with at least two cardiovascular risk factors and with a cardiovascular risk up to 15% measured using the Framingham-Regicor equation

Previous inclusion criteria:
1. Patients aged 18 or above
2. Patients with a cardiovascular risk between 5 and 15% in the REGICOR score

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

616

Participant exclusion criteria

1. Institutionalized patient, Barthel below 60, terminal illness, dementia or cognitive impairment
2. Myocardial infarction, bypass or coronary angioplasty in the last 3 months
3. Unstable coronary heart disease or untreated heart failure
4. Living outside the healthcare center area

Recruitment start date

01/01/2015

Recruitment end date

01/01/2017

Locations

Countries of recruitment

Spain

Trial participating centre

Illes Balears University
Cra. de Valldemossa, km 7.5. Palma (Illes Balears)
Spain

Sponsor information

Organisation

Universitat de les Illes Balears

Sponsor details

Cra. de Valldemossa
km 7.5
Palma (Illes Balears).
E-07122.
Spain
+34 (0) 971 17 30 00
anariera@uib.es

Sponsor type

Government

Website

https://www.uib.es/

Funders

Funder type

Research organisation

Funder name

Institute of Health Carlos III (Instituto de Salud Carlos III) (Spain) PI13_01477

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to publish one publication, the main results (effectiveness of the intervention)

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes