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临床试验/NCT03892239
NCT03892239已完成不适用

The Effectiveness of a Running-related Injury Prevention Program in Brazilian Runners: a Randomised Controlled Trial

Universidade Cidade de Sao Paulo2 个研究点 分布在 1 个国家目标入组 530 人开始时间: 2019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
发起方
入组人数
530
试验地点
2
主要终点
Running-related injuries (RRI)

研究概览

简要总结

Running is effective in increasing levels of physical activity and promotes a number of beneficial health effects. However, running can lead to running- related injuries (RRI). In theory, such injuries can be avoided with the implementation of prevention programs. But in practice, there is a paucity of prevention programs that are effective in reducing the risk of RRIs. In a previous study, the investigators developed an RRI prevention program using the Intervention Mapping framework. The RRI prevention program was named RunIn3. The present study will evaluate the effectiveness of the RunIn3 RRI prevention program.

Objective: To investigate the effectiveness of an RRI prevention program (i.e., RunIn3).

There will be recruited 530 runners of the state of São Paulo aged 18 years or older. After inclusion, participants will be randomly assigned and allocated in two groups: (1) intervention group, which will be the target of the implementation of the RunIn3 prevention program; and (2) control group, which will receive a minimal intervention (i.e., feedback based on surveillance).

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 (Investigator)

入排标准

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

入选标准

  • Running experience of at least three months;
  • Residents of the state of São Paulo;
  • No running-related injury (RRI) at baseline;
  • No history of RRI in the past three months.

排除标准

  • 未提供

结局指标

主要结局

Running-related injuries (RRI)

时间窗: After 12 months from baseline

Symptoms and complaints related to running will be measured and monitored by the Brazilian-Portuguese version of the Oslo Sports Trauma Research Center (OSTRC) Questionnaire on Health Problems (OSTRC-Br).

次要结局

  • Costs(After 12 months from baseline)
  • Incremental cost-effectiveness ratio (ICER)(After 12 months from baseline)
  • Behaviour(After 12 months from baseline)

研究者

发起方
Universidade Cidade de Sao Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luiz Carlos Hespanhol Junior

Associate Professor

Universidade Cidade de Sao Paulo

研究点 (2)

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