Study Design, Rationale, and Methodology for Promote Weight Loss in Patients With Peripheral Artery Disease Who Also Have Obesity: The PROVE Trial.
Study Design, Rationale, and Methodology for Promote Weight Loss in Patients With Peripheral Artery Disease Who Also Have Obesity: The PROVE Trial.
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DOI：
10.1161/jaha.123.031182
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发表时间：
2023-09-05
影响因子：
5.4
通讯作者：
McDermott, Mary M.
中科院分区：
文献类型：
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作者：
Whipple, Mary O.;Pfammatter, Angela Fidler;Spring, Bonnie;Rejeski, W. Jack;Treat-Jacobson, Diane;Domanchuk, Kathryn J.;Dressler, Emily V.;Ferrucci, Luigi;Gildea, Lois;Guralnik, Jack M.;Harvin, Lea;Leeuwenburgh, Christiaan;Polonsky, Tamar S.;Reynolds, Eric;Stowe, Cynthia L.;Sufit, Robert;Van Horn, Linda;Walkup, Michael P.;Ambrosius, Walter T.;McDermott, Mary M.
关键词：
超重和肥胖与外周动脉疾病（PAD）患者的不良功能结局相关。体重减轻对超重/肥胖和PAD患者的影响尚不清楚。PROVE（促进肥胖PAD患者体重减轻以防止活动能力丧失）试验是一项多中心随机临床试验，主要目的是测试旨在帮助PAD参与者减肥和步行锻炼的行为干预是否与单独步行锻炼相比在12个月随访时改善6分钟步行距离。共212例PAD和体重指数≥25 kg/m2的受试者将接受随机化。干预措施是使用群体中介认知行为干预模型，智能手机应用程序和个人电话辅导提供。主要结局是6分钟步行距离的12个月变化。次要结局包括12个月随访时每周步行运动的总分钟数和12个月加速度计测量的身体活动变化、步行障碍问卷距离评分和患者报告结局测量信息系统移动性问卷。三级结局包括6分钟步行结束时感知的劳力、饮食质量和短期体能测试组合的12个月变化。探索性结局包括腓肠肌活检测量线粒体细胞色素C氧化酶活性、线粒体生物发生、毛细血管密度和炎症标志物的变化。PROVE随机临床试验将评估运动与教练干预和旨在实现减肥的智能手机应用程序的效果，与单独运动相比，对PAD和超重/肥胖人群的步行表现。结果将为越来越多的超重/肥胖PAD患者提供最佳治疗。URL：https://www.clinicaltrials.gov;唯一标识符：NCT 04228978。
Overweight and obesity are associated with adverse functional outcomes in people with peripheral artery disease (PAD). The effects of weight loss in people with overweight/obesity and PAD are unknown. The PROVE (Promote Weight Loss in Obese PAD Patients to Prevent Mobility Loss) Trial is a multicentered randomized clinical trial with the primary aim of testing whether a behavioral intervention designed to help participants with PAD lose weight and walk for exercise improves 6‐minute walk distance at 12‐month follow‐up, compared with walking exercise alone. A total of 212 participants with PAD and body mass index ≥25 kg/m2 will be randomized. Interventions are delivered using a Group Mediated Cognitive Behavioral intervention model, a smartphone application, and individual telephone coaching. The primary outcome is 12‐month change in 6‐minute walk distance. Secondary outcomes include total minutes of walking exercise/wk at 12‐month follow‐up and 12‐month change in accelerometer‐measured physical activity, the Walking Impairment Questionnaire distance score, and the Patient‐Reported Outcomes Measurement Information System mobility questionnaire. Tertiary outcomes include 12‐month changes in perceived exertional effort at the end of the 6‐minute walk, diet quality, and the Short Physical Performance Battery. Exploratory outcomes include changes in gastrocnemius muscle biopsy measures of mitochondrial cytochrome C oxidase activity, mitochondrial biogenesis, capillary density, and inflammatory markers. The PROVE randomized clinical trial will evaluate the effects of exercise with an intervention of coaching and a smartphone application designed to achieve weight loss, compared with exercise alone, on walking performance in people with PAD and overweight/obesity. Results will inform optimal treatment for the growing number of patients with PAD who have overweight/obesity. URL: https://www.clinicaltrials.gov; Unique identifier: NCT04228978.
影响因子：
4.3
作者：
Raval, Zankhana;Liu, Kiang;Tian, Lu;Ferrucci, Luigi;Guralnik, Jack M.;Liao, Yihua;Criqui, Michael H.;McDermott, Mary M.
通讯作者：
McDermott, Mary M.
DOI：
10.1002/oby.21977
发表时间：
2017-11
期刊：
Obesity (Silver Spring, Md.)
影响因子：
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作者：
Beavers KM;Ambrosius WT;Rejeski WJ;Burdette JH;Walkup MP;Sheedy JL;Nesbit BA;Gaukstern JE;Nicklas BJ;Marsh AP
通讯作者：
Marsh AP