Effects of Physical Activity on Cardiovascular Risk and Quality of Life

A Randomized Community Trial of Physical Activity Intervention in Primary Healthcare to Improve Cardiovascular Risk Factors and Health-Related Quality of Life in Older Adults

Community intervention trial, randomized, to promote regular PA and social and cultural support activities for 9 months in older-adult primary care users and assess their effects on cardiovascular risk factors and health-related quality of life.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Quality of Life
• Intervention / Treatment: Behavioral: Physical, social and cultural activities

Detailed Description

A structured program to promote Physical , according to the recommended guidelines and supervised by healthcare personnel should be deployed to assess their short, medium and long-term effects on CVD risk and Qulity of life. The aim of this study was to evaluate the effectiveness of a program to promote Physical, social and cultural activities for 9 months on cardiovascular risk factors and quality of life among older-adults,

• Study Type: Interventional
• Enrollment (Actual): 419
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

* Adults users of 4 Primary Health Care Centers in Catalunya.

Exclusion Criteria:

• Previous episode of ischemic heart disease (<6 months).
• Outbreak of arthritis with limited ability to ambulate.
• Lung or heart disease with dyspnea mild-moderate efforts.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical, social and cultural activities; Physical Activity: The training program will be supervised by a physical activity specialist and will consiste of two aerobic exercise sessions per week, including walking and stretching exercises after walking. Each session will be 60 minutes and the size of groups will be from 15 to 30 participants. Additionally, participants will receive advice about the health benefits of PA and PHC nurses using different strategies to encourage the adherence of participants to the program. Social and cultural support activities. Activities will include: visits to museums and libraries, cultural exhibitions, tourist attractions and dance lessons. These activities will be performed once a month.	Behavioral: Physical, social and cultural activities; This intervention included two 60-min aerobic exercise sessions per week. Each session was supervised by a physical activity specialist and walking and stretching exercises were performed after programmed exercise sessions. PHC nurses were prepared to advise patients about the health benefits of PA and used different strategies to encourage the adherence of participants to the program. In addition, social and cultural support activities were included in this intervention program. These activities were performed once a month and they included: visits to museums and libraries, cultural exhibitions, tourist attractions and dance lessons.
No Intervention: Control Group; No intervention. We will measure the variables at the begining and after 9 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity level	It will assess at baseline and final by using the short form of the International Physical Activity Questionnarie (IPAQ-S) validated in the Catalan population. It provides a self-estimated number of hours dedicated to PA. The categories are: low, moderate and vigorous physical activity. IPAQ data will use to measure the total weekly Physical Activity level in metabolic equivalents (METs)/min/week by weighting time spent in each activity intensity level with an estimated metabolic equivalent (MET) energy expenditure	At the begining of the intervention and after 9 months.
Cardiovascular risk.	All participants will be asked if they have ever been diagnosed of hypertension, type 2 diabetes, dyslipidemia, overweight or obesity. Blood pressure will be measured with a sphygmomanometer after participants have been sitting quietly for at least five minutes; three recordings will be taken and the average of the second and third readings will be use. The cardiovascular risk will be calculated for each participant using the REGICOR scale based on Framingham criteria standardized for the Spanish population .	At the begining of the intervention and after 9 months
Biochemical analysis.	The biochemical parameters to analyze will be: Triglycerides, total cholesterol, HDL- and LDL-cholesterol; glycated hemoglobin and glucose. A unique study profile has been created to analyze all these parameters at the Tarraco laboratory (ISO9001:2000 certified ICS Tarragona laboratory). Blood will be extracted by PHC nurses from the fasting users in the corresponding PCC at 8:00 am. The same professional will take it to the central laboratory using the standard sample transport procedure between PCC and the central laboratory.	At the begining of the intervention and after 9 months.
Antropometric measurements.	Weight (kg) will be measured using a balance scale with the measurement taken to the nearest 0.1 kg. Height (cm) will be measured using a balance scale with the measurement taken to the nearest 1 cm. Weight and Height measurements will be then used to calculate the body mass index [BMI: Weight (kg)/ (Height) 2 (m2)]. Waist circumference (WC), will be measured finding the top of their hip bone and the bottom of their ribs. Threfore, the tape measure will be placed in the middle between these points and wrapped around the waist.	At the begining of the intervention and after 9 months.
Frequency of food consumption	We will use a validated food frequency questionnaire to assess food consumption. Participants will be asked to report the number of times per week or month that certain foods will be consumed (45-items). Foods will be grouped according to their nutrient composition: dairy (milk, yogurt, dairy desserts, cheese); meat/fish/eggs (red, white, processed meat and cold meat, lean, fatty fish and shellfish); total cereals (rice, pasta, bread, breakfast cereals, legumes -all type-, chocolate, biscuits, pastries and candies); fruits/vegetables (salad, tomatoes; vegetables side dish: aubergine, courgette, mushrooms; green beans, chards, spinaches, fresh fruits and canned fruits); oils and beverages (sweetened beverages, fermented beverages and alcoholic beverages), then the amount of g/day of each item will be calculated from the ECA-REF study's reference values.	At the begining of the intervention and after 9 months.
Health related quality of life	It will assess at baseline and final of the intervention with the Spanish version of the 36-item Short Form Health Survey (SF-36). It consists of 36 items used to measure health status and outcomes from the patient's point of view, including the following 8 health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. Two summary measures, the physical component summary (PCS) and the mental component summary (MCS), are derived from the last 8 health scores. Participant responses to each item gave a total numerical score which will transform to 0-100 scale, so that a higher score corresponds to a better health status.	At the begining of the intervention and after 9 months.

Collaborators and Investigators

• Sponsor: University Rovira i Virgili

Publications and helpful links

General Publications

• Arija V, Villalobos F, Pedret R, Vinuesa A, Jovani D, Pascual G, Basora J. Physical activity, cardiovascular health, quality of life and blood pressure control in hypertensive subjects: randomized clinical trial. Health Qual Life Outcomes. 2018 Sep 14;16(1):184. doi: 10.1186/s12955-018-1008-6.
• Arija V, Villalobos F, Pedret R, Vinuesa A, Timon M, Basora T, Aguas D, Basora J; Pas-a-Pas research group. Effectiveness of a physical activity program on cardiovascular disease risk in adult primary health-care users: the "Pas-a-Pas" community intervention trial. BMC Public Health. 2017 Jun 15;17(1):576. doi: 10.1186/s12889-017-4485-3.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: May 4, 2016
• First Submitted That Met QC Criteria: May 5, 2016
• First Posted (Estimate): May 10, 2016

Study Record Updates

• Last Update Posted (Estimate): May 10, 2016
• Last Update Submitted That Met QC Criteria: May 5, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: P11/67

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No