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临床试验/NCT05194059
NCT05194059已完成不适用

ActiPacMAN: 'Activity Pacing' in PLWH With Fatigue Symptoms. Monitoring Through the Combined Use of Actigraphy and Mobile App Notifications

Scientific Institute San Raffaele2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年12月3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
24
试验地点
2
主要终点
Activity pacing improvement

研究概览

简要总结

Physical activity helps to improve health and prevent chronic diseases. However, the fatigue usually hampers the training and execution of physical exercises, especially in people with chronic fatigue syndromes (CFCs), such as persons living with HIV (PLWH). We hypothesize that the "activity pacing", i.e. the strategy to optimize daily physical activity into manageable exercises in a way that should not exacerbate fatigue symptoms, may help a progressive improvement in physical activity of a group of PLWH with fatigue symptoms. Motivation and adherence to exercise will be monitored through the use of digital supports.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • of age ≥18 years;
  • either sedentary or already practicing mild/moderate physical activity (at least 150 minutes of moderate-intensity physical activity throughout the week);
  • able to sign the informed consent.

排除标准

  • The study will exclude HIV+ individuals:
  • with any HIV-related disease requiring hospitalization in the 6 weeks before enrolment;
  • with medical conditions (e.g. neurologic, muscular-skeletal, cardiovascular diseases) contraindicating non agonistic exercise, as established by a sport medicine specialist;
  • currently abusing of substance or alcohol;
  • already performing physical activity at higher level than the current WHO recommendations (30 minutes of moderate activity 5 times a week).

结局指标

主要结局

Activity pacing improvement

时间窗: 16 week

To compare the improvement in the physical fitness between the Experimental Group and Control Group

次要结局

未报告次要终点

研究者

发起方
Scientific Institute San Raffaele
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paola Cinque

Principal Investigator

Scientific Institute San Raffaele

研究点 (2)

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