Increasing Activity Post-Kidney Transplant With SystemCHANGE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Steps Taken Per Day by Using an Activity Tracker
研究概览
简要总结
Inactivity is a common problem among older kidney transplant recipients (KTRs) and is associated with their high incidence of obesity and cardiovascular problems which are the leading cause of death for KTRs. However, the combination of SystemCHANGE activity trackers holds promise for increasing physical activity of KTR patients post-surgery.
This pilot study will incorporate Fitbit health trackers with an intervention of questions about influences to physical activity in a population of kidney transplant recipients who are at particularly high risk of cardiovascular disease and death.
详细描述
This is a randomized study with intervention and control arms of sixty kidney transplant recipients age 60 and older. Demographic information will be collected during the screening phone call and will include: gender, race, marital status, income, education, transplant date, prescribed medications, type of diet, smoking status, and co-morbidities. All study data will be entered directly into electronic research forms using REDCap.
Overview of Intervention and Control Groups:
Intervention and control groups will be enrolled in the study in the same manner, receive the same instruction on use of the Fitbit and have the same number of study contacts. Group sessions will be held at the OSU Transplant Clinic with 10-12 participants for 6 months and a 6-month maintenance phase without contact from study personnel until month 12.
Intervention Group Active Phase, Group Session 1 (1 hour, 20 minutes): Research staff will demonstrate proper Fitbit activity tracker use, set up the smartphone application, and assist entry of daily step goals into the smartphone application. Fitbits will be set up with Gmail accounts with unique unidentifiable codes. Participants will be taught how to sync to their smartphone and retrieve data from their Fitbit. One week following this session, participants will be called to troubleshoot problems and be encourage to increase their step goal 5% each month (total phone time 15 minutes).
Intervention/Control Group Timeline:
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplant recipient at The Ohio State University Wexner Medical Center, Kidney Transplant Program
- •Age 60 or older
- •Received clearance from healthcare provider to participate
- •Ability to speak, read, and hear English
- •Possession or ready-access to a smart phone capable of accessing mobile activity tracker data
- •Lacks cognitive impairment (verified by mini cognition test)
- •Able to walk without an assist device (cane or walker)
- •Not currently hospitalized
- •Greater than 3 months post- transplant
排除标准
- •Currently on dialysis
- •Currently participating in a weight loss program
- •Currently participating in a structured exercise program
- •Currently wearing/using an activity tracker
- •Planning to relocate out of the Columbus area in the next 6 months or less
结局指标
主要结局
Steps Taken Per Day by Using an Activity Tracker
时间窗: (T2) 3months, (T3) 6months, & (T4)12 months
Steps were averaged per day.
次要结局
- Body Mass Index (BMI)kg/m2((T2) 3months, (T3) 6months, & (T4)12 months)
- Quality of Life: Physical (Functional) and Mental (Well-being) Health"((T2) 3months, (T3) 6months, & (T4)12 months)
- Six Minute Walk Test((T2) 3months, (T3) 6months, & (T4)12 months)
- Radial Pulse (Beats Per Minute)((T2) 3months, (T3) 6months, & (T4)12 months)
- Health Outcome: Waist Circumference (cm)((T2) 3months, (T3) 6months, & (T4)12 months)
- Resting Blood Pressure((T2) 3months, (T3) 6months, & (T4)12 months)
- Weight (Pounds)((T2) 3months, (T3) 6months, & (T4)12 months)