Low InTensity Exercise Intervention in PAD (LITE)
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Illinois
-
Chicago、Illinois、美国、60611
- Northwestern University
-
-
Louisiana
-
New Orleans、Louisiana、美国、70121
- Ochsner Baptist, Tulane University
-
-
Minnesota
-
Minneapolis、Minnesota、美国、55455
- University of Minnesota
-
-
Pennsylvania
-
Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
All participants will have PAD. PAD will be defined as follows. First, an ABI < or = 0.90 at the baseline study visit is a well-accepted standard for the diagnosis of PAD and will be an inclusion criterion. Second, people with an ABI of >0.90 and < or = 1.00 who experience a 20% ankle systolic pressure drop after the heel-rise test will also be included. Third, potential participants with an ABI > 0.90 who have vascular lab evidence of PAD or angiographic evidence of PAD who have ischemic symptoms during the six-minute walk and/or treadmill exercise stress test will be eligible. In addition to meeting a criterion for PAD, all participants must be symptomatic, defined by one of the following criteria:; a) ischemic leg symptoms (primarily assessed with the San Diego Claudication Questionnaire); b) report ischemic leg symptoms at the end of the six-minute walk; c) report ischemic leg symptoms at the end of the baseline treadmill stress test; d) walking impairment questionnaire results, e) interview with the potential participant about the presence and nature of leg symptoms during walking activity.
Exclusion Criteria:
- Above or below knee amputation, critical limb ischemia, wheelchair confinement, or foot ulcer.
- Individuals whose walking is limited by a condition other than PAD.
- > Class II NYHA heart failure or angina. Increase in angina, angina at rest, or abnormal baseline treadmill stress test.
- Major surgery including lower extremity revascularization or orthopedic surgery during the prior three months or anticipated in the next twelve months.
- Major medical illness including renal disease requiring dialysis, lung disease requiring oxygen other than at night, or cancer (other than non-melanoma skin cancer) requiring treatment in the prior three years. Potential participants may still qualify if they have had treatment for early stage cancer in the previous three years and the prognosis is excellent.
- Mini-mental status examination score <23, dementia, or psychiatric illness including severe depression or anxiety. Investigator discretion may be used to allow some people with an MMSE below 23 to participate if the investigator determines there is another reason for their lower score, including lack of sufficient familiarity with the English language or lack of sufficient education to achieve a score of 23 or higher.
- Currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention.
- Current or recent (within 3 months) participation in another clinical trial or cardiac rehabilitation. For a clinical trial of a stem cell or gene therapy intervention, potential participants will be potentially eligible immediately after the final study visit for the clinical trial, so long as long as at least six months has passed since the participant received their final treatment in the stem cell or gene therapy intervention. For a clinical trial involving open-label therapy in which the treatment is not related to functional performance and will not change during the LITE Trial, participants may still qualify for the LITE Trial based on investigator discretion.
- Individuals with PAD who have a history of lower extremity revascularization and have a normal ABI.
- Individuals who are not able to walk for exercise at a sufficiently slow pace to avoid ischemic leg symptoms.
学习计划
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:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Group 1
Low-intensity, self-paced walking exercise.
Home based exercise.
|
Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I).
During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach.
|
实验性的:Group 2
Standard high intensity, ischemic pain-inducing walking exercise.
Home based exercise.
|
Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I).
During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach.
|
有源比较器:Group 3
Non-exercising attention control group.
Contact with staff at same frequency as exercise groups, but staff deliver information on health not related to exercise.
|
Our attention control group controls for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention.
Participants randomized to the control group will attend weekly one-hour educational sessions at Northwestern University for the first four weeks of the intervention (Phase I).
These sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers.
Topics include Medicare Part D, nutritional supplements, and cancer screening.
During Phase II (weeks 5-52), the attention control group will receive weekly telephone calls, lasting 5-15 minutes, with information on a health-related topic.
|
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 |
---|---|---|
Six-minute Walk Distance
大体时间:change from baseline to week 52
|
In the six-minute walk, participants walk back and forth along a 100-ft hallway for six minutes after standardized instructions to complete as many laps as possible.
Distance covered in six minutes is recorded.
|
change from baseline to week 52
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Six-minute Walk Distance
大体时间:change from baseline to week 26
|
In the six-minute walk, participants walk back and forth along a 100-ft hallway for six minutes after standardized instructions to complete as many laps as possible.
Distance covered in six minutes is recorded.
|
change from baseline to week 26
|
Maximal Treadmill Walking Time
大体时间:change from baseline to week 52
|
In the treadmill walking test, participants walk on either a gardner or modified gardner protocol until they stop the test.
Time walked is recorded
|
change from baseline to week 52
|
Physical Activity Levels
大体时间:Change from baseline to week 52
|
ActiGraph measured physical activity
|
Change from baseline to week 52
|
Walking Impairment Questionnaire (WIQ) Distance and Speed Score.
大体时间:change from baseline to week 52
|
The WIQ is a well validated questionnaire that measures patient-reported walking limitations in distance and speed.
|
change from baseline to week 52
|
Health-related Quality of Life Measure
大体时间:change from baseline to week 52
|
The SF-36 physical functioning score will be used to measure quality of life.
|
change from baseline to week 52
|
Adherence to Intervention
大体时间:from baseline to week 52
|
Adherence is defined as the proportion achieving at least 80% of the prescribed exercise frequency and duration during the final month of the intervention.
|
from baseline to week 52
|
Change in Muscle Biopsy Measures of Mitochondrial Oxidative Metabolism and Oxidative Stress.
大体时间:change from baseline to week 52
|
Muscle tissue will be collected at baseline and follow up to measures Change in muscle biopsy measures of mitochondrial oxidative metabolism and oxidative stress.
|
change from baseline to week 52
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Qualitative Assessment
大体时间:At 52 week follow up
|
We will use qualitative methods to explore participants' perceptions of the exercise interventions in the high and low-intensity exercise groups, respectively.
|
At 52 week follow up
|
Physical Activity Levels Over Seven Days
大体时间:26 week follow-up.
|
ActiGraph
|
26 week follow-up.
|
WIQ Distance and Speed Score
大体时间:26 week follow-up
|
The WIQ is a well validated questionnaire that measures patient-reported walking limitations in distance and speed.
|
26 week follow-up
|
Health Related Quality of Life
大体时间:26 weeks
|
SF-36 physical functioning score.
|
26 weeks
|
Adherence to Assigned Intervention
大体时间:26 weeks.
|
Adherence is defined as the proportion achieving at least 80% of the prescribed exercise frequency and duration during the final month of the intervention.
|
26 weeks.
|
合作者和调查者
调查人员
- 首席研究员:Mary McDermott, MD、Northwestern University
出版物和有用的链接
一般刊物
- Hammond MM, Spring B, Rejeski WJ, Sufit R, Criqui MH, Tian L, Zhao L, Xu S, Kibbe MR, Leeuwenburgh C, Manini T, Forman DE, Treat-Jacobson D, Polonsky TS, Bazzano L, Ferrucci L, Guralnik J, Lloyd-Jones DM, McDermott MM. Effects of Walking Exercise at a Pace With Versus Without Ischemic Leg Symptoms on Functional Performance Measures in People With Lower Extremity Peripheral Artery Disease: The LITE Randomized Clinical Trial. J Am Heart Assoc. 2022 Aug 2;11(15):e025063. doi: 10.1161/JAHA.121.025063. Epub 2022 Jul 27.
- Slysz JT, Rejeski WJ, Treat-Jacobson D, Bazzano LA, Forman DE, Manini TM, Criqui MH, Tian L, Zhao L, Zhang D, Guralnik JM, Ferrucci L, Kibbe MR, Polonsky TS, Spring B, Sufit R, Leeuwenburgh C, McDermott MM. Sustained physical activity in peripheral artery disease: Associations with disease severity, functional performance, health-related quality of life, and subsequent serious adverse events in the LITE randomized clinical trial. Vasc Med. 2021 Oct;26(5):497-506. doi: 10.1177/1358863X21989430. Epub 2021 Apr 8.
- McDermott MM, Spring B, Tian L, Treat-Jacobson D, Ferrucci L, Lloyd-Jones D, Zhao L, Polonsky T, Kibbe MR, Bazzano L, Guralnik JM, Forman DE, Rego A, Zhang D, Domanchuk K, Leeuwenburgh C, Sufit R, Smith B, Manini T, Criqui MH, Rejeski WJ. Effect of Low-Intensity vs High-Intensity Home-Based Walking Exercise on Walk Distance in Patients With Peripheral Artery Disease: The LITE Randomized Clinical Trial. JAMA. 2021 Apr 6;325(13):1266-1276. doi: 10.1001/jama.2021.2536.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Exercise的临床试验
-
University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的