Effectiveness of a brief multifactorial intervention in adherence to physical exercise prescription of moderate to high cardiovascular risk patients

ISRCTN	ISRCTN76069254
DOI	https://doi.org/10.1186/ISRCTN76069254
Secondary identifying numbers	PI13/01477

Submission date: 21/11/2014
Registration date: 08/04/2015
Last edited: 17/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Mr Aina Riera
Public

Departament d'Infermeria i Fisioteràpia
Universitat de les Illes Balears. Cra. de Valldemossa, km 7.5
Palma (Illes Balears)
07122.
Spain

Phone	+34 (0) 971 17 30 00
Email	ana.riera@uib.es

Study information

Study design	Two-arm multicenter randomized clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Prevention
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
Study objectives	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(s)	Ballearic Island Ethics Committee, 11/06/2014, 23/41/14PI
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	12/06/2014
Completion date	12/12/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	616
Total final enrolment	263
Key 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
Key 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
Date of first enrolment	01/01/2015
Date of final enrolment	01/01/2017

Locations

Countries of recruitment

Spain

Study participating centre

Illes Balears University

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

Sponsor information

Universitat de les Illes Balears
Government

Cra. de Valldemossa, km 7.5
Palma (Illes Balears).
E-07122.
Spain

Phone	+34 (0) 971 17 30 00
Email	anariera@uib.es
Website	https://www.uib.es/
"ROR"	https://ror.org/03e10x626

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	We intend to publish one publication, the main results (effectiveness of the intervention)
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/09/2017	17/12/2020	Yes	No
Results article	results	01/03/2021	17/12/2020	Yes	No

Editorial Notes

17/12/2020: Publication reference and total final enrolment added.