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临床试验/NCT03423238
NCT03423238已完成不适用

Targeting Obesity to Optimize Health in Cardiac Rehab (TOPCARE)

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2018年3月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
Compliance - Percentage of Sessions Attended

研究概览

简要总结

Although coronary heart disease (CHD) treatment guidelines recognize obesity as a major modifiable risk factor,2 nearly half of all CHD patients are obese and the current standard of care fails to implement evidence-based obesity treatment for this high-risk population. Multiple lines of evidence suggest that weight loss improves outcomes in CHD patients. The primary goal of this study is to determine the feasibility of adding a 6-month behavioral weight loss intervention to exercise-based cardiac rehabilitation.

详细描述

Although coronary heart disease (CHD) treatment guidelines recognize obesity as a major modifiable risk factor,2 nearly half of all CHD patients are obese and the current standard of care fails to implement evidence-based obesity treatment for this high-risk population. The efficacy of exercise-based cardiac rehabilitation for improving exercise capacity and CHD risk factors is markedly blunted in CHD patients with obesity. Current programs largely focus on nutrient intake and produce minimal weight loss, on average. Our data show that despite appropriate exercise prescription and adherence, only 22% of CHD patients with obesity lose even the minimum recommended body weight over a 3-month program. These findings indicate that targeting reductions in caloric intake is needed to optimize outcomes in these patients and suggest that current programs are too short to produce adequate weight loss and ensure the necessary behavioral adaptations for long-term maintenance. Randomization to diet-induced weight loss in combination with aerobic exercise improves exercise capacity, quality of life, and CHD risk factors more than exercise alone and reduces long-term mortality in overweight and obese adults. The primary goal of this study is to determine the feasibility of adding a 6-month behavioral weight loss intervention to exercise-based cardiac rehabilitation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

All assessments will take place by study staff blinded to the participant's treatment assignment. To ensure that staff remain blinded, participants will be asked not to discuss their intervention with the assessor

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • documented CHD defined as hospitalization for MI/heart attack coronary artery bypass grafting (CABG) or percutaneous coronary intervention (i.e., angioplasty, stent)
  • age = 40 and older
  • overweight or obese based on an elevated BMI (≥25 kg/m2)

排除标准

  • body weight >450 lbs
  • congestive heart failure (ejection fraction <35%)
  • advanced kidney disease (on dialysis, or dialysis anticipated within 6 months)
  • cognitive impairment (Montreal Cognitive Assessment [MoCA] score <22)
  • major depression (Patient Health Questionnaire [PHQ-9] ≥20)
  • severe pulmonary disease (i.e., oxygen-dependent)
  • significant impairment from a prior stroke or other neurologic disease or injury
  • high risk for non-adherence (i.e., unwilling or unable to comply with study requirements)
  • current participation in physical therapy or another weight loss study
  • current or recent use of weight loss medications (e.g., orlistat)
  • prior weight loss procedure
  • drug/substance abuse or excessive alcohol (> 14 drinks per week) within the past 6 months
  • pregnant or pre-menopausal women
  • peanut allergy
  • milk allergy/lactose intolerance

结局指标

主要结局

Compliance - Percentage of Sessions Attended

时间窗: 6 months

The percentage of exercise/counseling sessions attended (calculated as the number of sessions attended divided by the number of sessions prescribed multiplied by 100)

Feasibility - Number of Enrolled Participants

时间窗: 18 months

Total number of participants who met all inclusion/exclusion criteria and were enrolled in the study

Retention - Percentage of Participants Who Returned for Follow-up Testing

时间窗: 6 months

The number of participants who returned for the 6-month follow-up visit divided by the total number of randomized participants multiplied by 100

次要结局

  • 6 Minute Walk (6MW) Test(Months 3 and 6)
  • Health-related Quality of Life SF-36 - Mental Component Summary (MCS) Score(Months 3 and 6)
  • Health-related Quality of Life SF-36 - Physical Component Summary (PCS) Score(Months 3 and 6)
  • Body Weight(Months 3 and 6)
  • Grip Strength(Months 3 and 6)
  • Mobility - MAT-sf(Months 3 and 6)
  • Hemoglobin A1c(Months 3 and 6)
  • Brachial Blood Pressure - Diastolic(Months 3 and 6)
  • Expanded Short Physical Performance Battery (eSPPB)(Months 3 and 6)
  • Arterial Stiffness(Months 3 and 6)
  • Brachial Blood Pressure - Systolic(Months 3 and 6)
  • Aortic Blood Pressure - Systolic(Months 3 and 6)
  • Aortic Blood Pressure - Diastolic(Months 3 and 6)
  • Fasting Insulin(Months 3 and 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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