Physical Activity in Adolescents With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in time spent in moderate to vigorous physical activity (minutes/day)
研究概览
简要总结
The goal of this is to test the efficacy of a 12-week physical activity intervention in 64 adolescents with CKD.
详细描述
For youth with chronic kidney disease (CKD), cardiovascular disease (CVD) is a leading cause of morbidity and early mortality. Physical activity is a well-recognized determinant of health and quality of life, but, youth with CKD are less physically active than their healthy peers. Identification of effective strategies to increase physical activity in youth with CKD is paramount to improving outcomes. The investigators will test the efficacy of a 12-week physical activity intervention in 64 adolescents with CKD. Guided by the Multiphase Optimization Strategy (MOST) framework, an optimization trial will identify intervention components that increase average daily moderate to vigorous physical activity by 15 min/day, a clinically meaningful increase. The components will be grounded in established behavioral change theories and be delivered via Way to Health, a web-based platform, to overcome barriers at the point of clinical care where time and resources are limited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
盲法说明
Principal investigator and Clinical Care providers will be masked to intervention. Research Coordinator will not be masked
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •For adolescent participants:
- •Pregnant or lactating
- •Non-ambulatory
- •Have high physical activity at baseline (>45 min/day of MVPA)
- •Provide <2 days of physical activity data during the run-in period
- •Have a condition, such as heart or lung disease, that preclude safely engaging in physical activity
- •Have received a solid organ transplant
- •Have limited English proficiency
- •Are on dialysis
- •In the opinion of the investigator, are unable to comply with the requirements of the study protocol or are unsuitable for the study for any reason
- •For caregivers participants:
- •1. Limited English proficiency
结局指标
主要结局
Change in time spent in moderate to vigorous physical activity (minutes/day)
时间窗: pre 12 week intervention and post 12 week intervention
Change in time spent in moderate to vigorous physical activity measured by Fitbit over the course of 12 weeks
次要结局
- Participant feedback(at the end of the 12 week intervention)
- moderate to vigorous physical activity at 6 months(6 months)
- PROMIS Anxiety(pre 12 week intervention and post 12 week intervention)
- PROMIS Depressive Symptoms(pre 12 week intervention and post 12 week intervention)
- PROMIS Positive Affect(pre 12 week intervention and post 12 week intervention)
- PROMIS Anger(pre 12 week intervention and post 12 week intervention)
- PROMIS Psychological Stress Experiences(pre 12 week intervention and post 12 week intervention)
- Change in hand grip strength (age and sex based z-scores)(pre 12-week intervention and post 12-week intervention)
- PROMIS Fatigue(pre 12 week intervention and post 12 week intervention)
- PROMIS Sleep Disturbance(pre 12 week intervention and post 12 week intervention)
- PROMIS Sleep-Related Impairment(pre 12 week intervention and post 12 week intervention)
- PROMIS Life Satisfaction(pre 12 week intervention and post 12 week intervention)