Lifestyle Intervention In CKD (CKD-LIFE)
2026年6月8日 更新者:Duke University
Multi-component Lifestyle Intervention to Improve Outcomes in Chronic Kidney Disease
This research study will test whether a 12-week healthy lifestyle program offered through a cardiac rehabilitation center can help lower blood pressure and improve kidney health in adults with advanced chronic kidney disease.
Participants will be randomly assigned to either routine kidney health education or take part in a program that includes healthy eating guidance, supervised exercise sessions, and wellness coaching.
The goal of the study is to determine whether this program can improve blood pressure and other factors linked to worsening kidney disease.
研究概览
详细说明
This single-site randomized controlled trial will evaluate the blood pressure and kidney effects of a 12-week structured, cardiac rehabilitation-based lifestyle intervention in adults with advanced chronic kidney disease.
Participants will be randomized to usual care or a multi-component, cardiac rehabilitation center-based lifestyle intervention, including diet modification, supervised exercise, and wellness counseling.
The study aims to determine whether the intervention improves systolic blood pressure and related determinants of chronic kidney disease progression.
研究类型
介入性
注册 (估计的)
152
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Crystal Tyson, MD
- 电话号码:919-660-6860
- 邮箱:crystal.simpson@duke.edu
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Black race; ≥18 years old
- history of hypertension
- SBP ≥120 or DBP ≥80 mm Hg average of three measurements at screening visit (per KDIGO recommended SBP target of <120 mm Hg)48
- Stable anti-hypertensive medication regimen (i.e., no medication changes 4 weeks prior to enrollment);
- eGFR of 15-44 ml/min/1.73m2 at screening visit
- agreeable to randomization to either of the 2 study arms
Exclusion Criteria:
- currently receiving or needing dialysis; having received or needing a kidney transplant
- acute kidney injury at time of screening
- average SBP ≥ 180 mm Hg or DBP ≥ 110 mm Hg at screening
- Exaggerated systolic response during ETT (e.g., SBP >210 mmHg in men or >190 mmHg in women)
- underweight (BMI <18.5 kg/m2)
- planned weight loss surgery in 1 year
- a score of 27 or higher on the BP medication adherence scale
- cardiac condition that would preclude participation in aerobic exercise training, including severe ischemic heart disease (CCS Class 3 or 4 angina or evidence of ischemia at <85% heart rate reserve on screening treadmill testing), severe heart failure (NYHA Class 3 or 4), high grade arrhythmias, severe valvular heart disease
- severe asthma or chronic obstructive lung disease
- musculoskeletal or neurologic conditions that would preclude participation in aerobic exercise training
- a major psychiatric disorder
- illicit drug abuse
- current alcohol consumption >14 drinks/week for men and >7 drinks/week for women
- pregnant or planned pregnancy within 1 year
- gastric bypass surgery within the last 2 years
- a life-limiting comorbid medical condition, such as cancer.
- physical limitation, gait instability, or need for continuous weight-bearing support that, in the opinion of study staff, would prevent safe completion of exercise treadmill testing
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Lifestyle Intervention
Participants receive CKD education plus a 12-week cardiac rehabilitation-based lifestyle program including supervised exercise, DASH-based diet counseling, and weight management.
|
Cardiac rehabilitation-based program including supervised exercise, DASH-based dietary counseling, and wellness support over 12 weeks.
|
|
有源比较器:Usual Care
Participants receive CKD education only.
|
Routine medical care in addition to 1) one 30-minute counseling session with dietician and 2) an exercise prescription
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in clinic systolic blood pressure (SBP)
大体时间:Baseline, 3 months, 9 months
|
Three BP values obtained one minute apart will be obtained and averaged to define clinic BP for that time point.
|
Baseline, 3 months, 9 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in DASH diet adherence score
大体时间:Baseline, 3 months, 9 months
|
Completion of 24-hour dietary recalls using the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool
|
Baseline, 3 months, 9 months
|
|
Change in 24-hour urinary sodium-to-potassium ratio
大体时间:Baseline, 3 months, 9 months
|
one 24-hour urine sample will be collected to objectively assess diet adherence to the DASH diet using biomarkers, such as sodium and potassium
|
Baseline, 3 months, 9 months
|
|
Change in 6-minute walk test
大体时间:Baseline, 3 months, 9 months
|
Participants will be instructed to walk as far as possible for six minutes along a flat, straight course, with standardized encouragement provided at set intervals in accordance with American Thoracic Society guidelines.
The total distance walked (in meters) is recorded.
|
Baseline, 3 months, 9 months
|
|
Change in 24-hour urine albumin excretion
大体时间:Baseline, 3 months, 9 months
|
Urine albumin and creatinine concentrations will be determined from one 24-hour urine collection to assess for albuminuria (or from random sample in the event 24-hour sample cannot be collected).
|
Baseline, 3 months, 9 months
|
|
Change in clinic diastolic blood pressure (DBP)
大体时间:Baseline, 3 months, 9 months
|
Three BP values obtained one minute apart will be obtained and averaged to define clinic BP for that time point.
|
Baseline, 3 months, 9 months
|
|
Change in 24-hour systolic blood pressure (SBP)
大体时间:Baseline, 3 months, 9 months
|
Blood pressure monitor will be provided to participants to take home.
Monitor will be programmed to take BP measurements every 20-30 minutes during waking hours and every 30-60 minutes during the nighttime sleep period.
|
Baseline, 3 months, 9 months
|
|
Change in 24-hour diastolic blood pressure (DBP)
大体时间:Baseline, 3 months, 9 months
|
Blood pressure monitor will be provided to participants to take home.
Monitor will be programmed to take BP measurements every 20-30 minutes during waking hours and every 30-60 minutes during the nighttime sleep period.
|
Baseline, 3 months, 9 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Crystal Tyson, M.D.、Duke University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月14日
初级完成 (估计的)
2029年6月30日
研究完成 (估计的)
2030年6月30日
研究注册日期
首次提交
2026年6月2日
首先提交符合 QC 标准的
2026年6月2日
首次发布 (实际的)
2026年6月8日
研究记录更新
最后更新发布 (实际的)
2026年6月10日
上次提交的符合 QC 标准的更新
2026年6月8日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- PRO00118256
- 1R61HL178691 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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