NCT05147883Unknown不适用
The Effect of Exercise on Quality of Life, Sleep Quality and Anxiety in Patients With Prediabetes (EFEXQULS)
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Score of Quality of Life
研究概览
简要总结
The aim of this study is to determine the effect of exercise on quality of life, sleep quality and anxiety in patients with prediabetes.
详细描述
Randomized controlled studies are needed to examine the effects of exercise on sleep quality, quality of life, anxiety and depression in patients with prediabetes.
The aim of this study is to determine the effect of exercise on quality of life, sleep quality and anxiety in patients with prediabetes.
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 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-59 years old
- •Living a sedentary life (physical activity below 300 kcal/day will be evaluated with the Minnesota Leisure Physical Activity Questionnaire)
- •Those who have sufficient motivation to participate in the exercise program (will be evaluated by a one-on-one interview by the researchers)
- •Those diagnosed with prediabetes by oral glucose tolerance test and/or HbA1c measurement will be included.
- •Being eligible to participate in an exercise program after a cardiac examination (resting ECG and questioning of cardiac symptoms, advanced tests such as exercise ECG test if necessary) performed by the physician
排除标准
- •Serious medical condition (for example, advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.) that would prevent the person from participating in exercise training.
- •Having cardiovascular disease
- •Being diabetic
- •Receiving hormone replacement therapy
- •Life expectancy less than 1 year
- •HIV positivity
- •Substance use
- •Functional dependency
- •Cognitive weakness
- •Those who have other diseases that will affect the results of the study (respiratory diseases, muscle diseases, etc.)
- •Those who use drugs or supplements that will affect the results of the study
结局指标
主要结局
Score of Quality of Life
时间窗: 1 week
Quality of Life evaluated with Health-Related Short Form-36 Survey(Min-Max:0-100). High score idicates high quality of life.
次要结局
- Anxiety(1 week)
- Sleep Quality(1 week)
- Depression(1 week)
研究者
Elif Yıldırım Ayaz
Principal Investigator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
研究点 (2)
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