Virtually Supervised Exercise for Kidney Transplant Candidates
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Change in performance on 30 second sit to stand test
研究概览
简要总结
This study is examining whether a virtually supervised exercise program can improve physical function in persons who are awaiting kidney transplant. The investigators will compare the results to a similar group of persons who receive a health education program.
详细描述
This study is examining if a virtually supervised exercise program can improve physical function in persons awaiting kidney transplant. A double-blind, parallel group randomized controlled clinical trial, this study will enroll 80 persons for 24 weeks. Our primary outcome is performance on the 30 second sit to stand test, and our secondary outcomes are changes in the Fatigue Severity Scale and the Beck Depression Inventory.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old
- •Listed for kidney transplant
- •Positive answers (e.g. yes) to one of the following:
- •current difficulty with climbing up 10 stairs,
- •has changed in the past year how they climb 10 stairs
- •current difficulty with walking a 0.5 mile (5-6 blocks)
- •has changed in past year in how they walk 0.5 mile (5-6 blocks)
- •documented performance of 430 meters or less on the six minute walk test in the past 12 months
- •documented performance of 9 points or less on the Short Physical Performance Battery in the past 24 months
- •documented performance of less than 3 points or less on the five times sit to stand test in the past 24 months
- •Demonstrated ability to stand up independently from a seated position and then sit back down without using their arms or an assistive device in the past 24 months
排除标准
- •Does not speak English or Spanish
- •Nursing home resident
- •Severe low vision (≥20/200 with corrective lens)
- •Severe hearing loss even with use of amplification preventing communication
- •Unstable angina or uncontrolled arrhythmia
- •Supplemental oxygen therapy
- •Myocardial infarction, major heart surgery, stroke, venous thromboembolism, hip fracture, hip or knee replacement in past six months (temporary exclusion)
- •≥ 3 errors on the Six Item Screener
研究组 & 干预措施
Virtually supervised exercise
In the first half of the study (weeks 0 to 12), participants will receive a virtually supervised exercise program. In the second half of the study (weeks 13 to 24), participant will continue to receive the virtually supervised exercise program.
干预措施: Virtually supervised exercise (Behavioral)
Health education
In the first half of the study (weeks 0 to 12), participants will receive a health education program. In the second half of the study (weeks 13 to 24), participant will receive a the virtually supervised exercise program.
干预措施: Virtually supervised exercise (Behavioral)
Health education
In the first half of the study (weeks 0 to 12), participants will receive a health education program. In the second half of the study (weeks 13 to 24), participant will receive a the virtually supervised exercise program.
干预措施: Health education (Behavioral)
结局指标
主要结局
Change in performance on 30 second sit to stand test
时间窗: Baseline through week 12
Number of times that a person can stand up from a sitting position in 30 seconds
次要结局
未报告次要终点
研究者
Christine Liu
Assistant Professor of Medicine
Stanford University