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临床试验/NCT01567007
NCT01567007Unknown不适用

Impact of Different Interventions in Physical Activity Level and Co-morbidities in Women: Randomized, Controlled Study

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
195
试验地点
2
主要终点
Change after 3 and 6 months from Baseline in weekly steps number mean measured by a pedometer

研究概览

简要总结

The purpose of this study is to evaluate the impact of different types of intervention on physical activity level and co-morbidities in women workers aged between 40 and 50 years. Method: A total of 195 sedentary women aged between 40 and 50 years and those who agreed to participate were randomized to one of the following interventions: GI = Control (n = 47), GII = Individual counseling (n = 53), GIII = Counseling group (n = 48); GIV = physical training set (n = 47). Were evaluated: Physical Activity level (steps number evaluated by a pedometer), quality of life (SF-36), body composition (BMI, waist circumference and bioelectrical impedance) and clinical variables (plasma glucose and blood pressure).

详细描述

Protocols and Randomization of subjects: Subjects were randomized into 4 groups: control group (GI), individual counseling (GII), group counseling (GIII) and aerobic training set (GIV). The protocols of interventions are described in detail below:

GI - Control: Comprising session of 15-20 minutes duration. It took place guidelines on physical activity, delivering a manual with general information about physical activity.

GII - Individual counseling: Consisting of three sessions within a maximum period of 3 months. We conducted a counseling, aimed at increasing physical activity, aiming to raise at least 2000 steps over the first week of monitoring. Furthermore, we discuss the importance of physical activity, such as overcoming barriers to physical activity and targets agreed between the parties. The pedometer is given along with a diary to record the number of steps and returned in the last session.

GIII - Group Counseling: The counseling was conducted in groups (10-12 individuals) for 6 sessions at weekly intervals, and two sessions with fortnightly. Each session lasts 60 minutes. The advice is aimed at behavioral changes using the following approaches: advantages and disadvantages of behavior change, how to overcome barriers to physical activity, self-monitoring of physical activity by using the pedometer and setting goals (number of steps / day) in the short term and what to do in case of relapse (not accomplish what was represented) besides livings practices. As the GII and the goal is to raise steps daily, with the main focus physical activity in leisure time and transport.

GIV - Programmed Aerobic Training: The fitness program is held two times per week with individuals and groups with three sessions lasts for 40 minutes performed on a treadmill.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
40 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Apparently healthy (no serious chronic disease), sedentary (less than 60 minutes of aerobic physical activity per week scheduled), employees of HC / FMUSP aged between 40 and 50 years.

排除标准

  • Perform some type of pharmacotherapy for weight reduction, have a BMI > 45 kg/m2 and have functional limitations that would prohibit the execution of hiking.

结局指标

主要结局

Change after 3 and 6 months from Baseline in weekly steps number mean measured by a pedometer

时间窗: Change after 3 and 6 months of the baseline evaluation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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