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临床试验/NCT03981965
NCT03981965已完成不适用

Impact of FOCUS Guidelines on Adherence to Physical Activity in Ageing Women.

University of Valencia2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Adherence: Level of adherence to the program as assessed by attendance to the physical activity sessions.

研究概览

简要总结

The study aimed at assessing whether the guidelines from the European project FOCUS had an effect on adherence to a physical activity program in older women. The program consisted of two 12-week periods, in which women followed a set of pre-specified exercises (1 hour, twice per week). The first period was supervised by a monitor while the second was autonomous. Support groups, in which the contact between participants was established through information and communication technologies (social-network through the mobile phone), were set up to maintain engagement between participants. Women were randomized to three arms consisting of 2 intervention groups, with and without the FOCUS guidelines, and a sedentary control. Secondary outcomes included a battery of dimensions affecting physical performance, psychological status, and quality of life.

详细描述

The objectives of the study consisted of assessing i) whether the use of the Guidelines derived from the European project FOCUS had an effect on the adherence to a physical activity (PA) program (primary objective), and ii) the effect of the program, which included 2 h/week of PA, on a group of dimensions related with general health, frailty, psycho-cognitive parameters, and quality of life (QoL) (secondary objectives).

The study comprised 24 weeks in which a group of 90 postmenopausal women were randomised to three arms, two in which participants were performing PA, and one control (no intervention).

The first PA group followed the FOCUS guidelines, in which women received monthly health talks and had an internet mailbox to facilitate contact with health professionals.

The PA program consisted of a twice per week 1-hour session along 24 weeks. This period was divided into two parts, a first supervised phase in which women followed group sessions under direct supervision of a monitor, and a second period in which the groups of women followed the same exercise pattern, but autonomously. A mobile phone support system (social network whatsapp) was used for inter-connection and mutual support during the autonomous period. Assessments were performed at baseline and then at 12 weeks and 24 weeks, representing the completion of the supervised and the autonomous periods, respectively.

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
50 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Community living postmenopausal women capable of performing the physical activity program and with ability to sign the informed consent.

排除标准

  • Physical or psychological deficiencies incapacitating subjects to participate in the established physical program.

结局指标

主要结局

Adherence: Level of adherence to the program as assessed by attendance to the physical activity sessions.

时间窗: 6 months

Attendance will be measured as a percentage of the total number of sessions.

次要结局

  • Frailty: changes in frailty as assessed by the Fried index(6 months)
  • Social activities(6 months)
  • Mood status(6 months)
  • Sleep quality, measured as per Athens Insomnia scale(6 months)
  • Cognitive function(6 months)
  • Psychological well-being as measured by the 52-item Ryff scale(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Cano Sanchez

Full Professor Obstetrics and Gynecology

University of Valencia

研究点 (2)

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