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临床试验/NCT02767739
NCT02767739已完成不适用

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

University Rovira i Virgili0 个研究点目标入组 419 人开始时间: 2011年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
419
主要终点
Biochemical analysis.

研究概览

简要总结

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.

详细描述

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,

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Biochemical analysis.

时间窗: At the begining of the intervention and after 9 months.

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.

Physical activity level

时间窗: At the begining of the intervention and after 9 months.

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

Antropometric measurements.

时间窗: At the begining of the intervention and after 9 months.

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.

Frequency of food consumption

时间窗: At the begining of the intervention and after 9 months.

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.

Health related quality of life

时间窗: At the begining of the intervention and after 9 months.

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.

Cardiovascular risk.

时间窗: At the begining of the intervention and after 9 months

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 .

次要结局

未报告次要终点

研究者

发起方
University Rovira i Virgili
申办方类型
Other
责任方
Principal Investigator
主要研究者

Victoria Arija Val

Phd

University Rovira i Virgili

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