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临床试验/NCT01729650
NCT01729650已完成不适用

Effectiveness of a Physical Activity and Diet Program, Coordinated Between Primary Care and Mental Health, to Modify Cardiovascular Risk Factors in Patients With Schizophrenia or Bipolar Disorder (CapiCor)

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina2 个研究点 分布在 1 个国家目标入组 332 人开始时间: 2012年6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
332
试验地点
2
主要终点
waist circumference (cm)

研究概览

简要总结

The aim is to evaluate the effectiveness of an intervention based on a program of physical activity and diet coordinated between primary care teams (PCT) and Mental Health Centres (MHC) to modify the weekly physical activity (PA) amount, body mass index (BMI) and waist circumference in patients with severe mental disorder diagnoses. To assess changes in cardiovascular risk, quality of life and lifestyles, secondarily. Methods: A randomized clinical trial with a control group, of one year of follow-up, carried out in four MHC Barcelona and Santa Coloma, and PCT of reference. The investigators studied patients aged 18 - 65 years old, diagnosed with schizophrenia, schizoaffective or bipolar disorder, with antipsychotic medication and a low level of PA. 240 patients will be selected in each group (difference to be detected in the BMI:> 1.89 kg/m2; common SD: 6.2, 30% loss). Intervention: group educational PA program (basically walking) of 24 sessions over 12 weeks, and diet (8 sessions in the first 8 weeks) by nurses and specialists in PA. Key measurements: level of PA (IPAQ questionnaire), physical examinations: BMI, waist circumference, blood pressure, cardiovascular risk, quality of life (SF-36), smoking habits, dietary habits (PREDIMED questionnaire), analytical parameters: cholesterol , triglycerides, blood glucose. Evaluations will be masked and conducted at 0, 3, 6 and 12 months. Analysis of variance for repeated measures to adjust for differences attributable to the effect of the intervention for potential confounders: pharmacological treatment, care level of intervention and mental state.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 18 and 65 years old,
  • understand Catalan or Spanish
  • will be located for at least twelve months.
  • Psychiatric disorders with ICD-10 diagnosis codes: F20*, F31* and F25*.
  • Taking an antipsychotic drug at, a least, three months
  • Low physical activity level

排除标准

  • Active addiction to psychoactive drugs, except tobacco.
  • Pregnancy
  • Diseases that doesn't allow physical activity
  • Psychotic acute exacerbation in the last month

结局指标

主要结局

waist circumference (cm)

时间窗: : the outcome measure is studied at 3, 6 and 12 months

Change in weekly level of physical activity (IPAQ questionnaire),

时间窗: : the outcome measure is studied at 3, 6 and 12 months

Body mass index (kg/m²)

时间窗: : the outcome measure is studied at 3, 6 and 12 months

次要结局

  • blood pressure (mm hg)(the outcome measure is studied at 3, 6 and 12 months)
  • cardiovascular risk with the Regicor coronary risk to 10 years(the outcome measure is studied at 3, 6 and 12 months)
  • Quality of life (SF-36 questionnaire)(the outcome measure is studied at 3, 6 and 12 months)
  • Dietary habits (PREDIMED questionnaire)(the outcome measure is studied at 3, 6 and 12 months)
  • Analytical parameters: cholesterol , triglycerides, blood glucose mg/100 ml.(the outcome measure is studied at 3, 6 and 12 months)
  • Smoking habits: smoker/ ex-smoker/no-smoker. Number of cigarettes per day.(the outcome measure is studied at 3, 6 and 12 months)

研究者

发起方
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
申办方类型
Other
责任方
Sponsor

研究点 (2)

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