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临床试验/NCT05853497
NCT05853497已完成不适用

A Multi-Component Weight Loss Intervention to Improve Outcomes of Total Knee Replacement

University of Kansas Medical Center1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Participant Retention Feasibility

研究概览

简要总结

Obesity, specifically BMIs ≥35 or 40 kg/m2, are associated with an increased probability of poor outcomes of Total Knee Arthroplasty (TKA) including increased pain, risk for infection, poor joint function, and increased rates of hospital readmissions. Several orthopedic and public health organizations recommend weight loss prior to TJA for individuals with overweight/obesity. However, empirical evidence suggesting the effectiveness of pre-surgical weight loss on surgical and functional outcomes of TKA is extremely limited and is based primarily on non-randomized observational studies. Thus, to gain further insight regarding the feasibility and potential effectiveness of pre-surgical weight loss on outcomes of TKA, the proposed pilot trial will randomize 30 patients (age 50-75 yrs., BMI 35<40 kg/m2) scheduled for TKA through The University of Kansas Health System Department of Orthopedics and Sports Medicine (KUOrtho) to a multi-component weight loss (3-mo. pre-TKA, very low-calorie diet) and maintenance intervention (3-mo. post TKA, conventional maintenance diet) or standard care control which will include no dietary or weight loss advice. The weight loss/maintenance interventions will include reduced energy intake or energy intake prescribed for weight loss maintenance, increased physical activity, and individual behavior counseling. Outcomes will be assessed 1) baseline, i.e., 3 mos. prior to surgery, 2) 3 mos. i.e., at the completion of the weight loss intervention prior to TKA, 3) within a minimum of 2 weeks post TKA, and 4) 3 mos. post-TKA, i.e., after completion of the weight maintenance intervention to assess the feasibility and effectiveness of a remotely delivered multi-component pre-TKA weight loss and a post-TKA weight maintenance intervention.

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
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age: 50-75 years
  • •BMI: 35 to ≤40 kg/m2
  • •Patient of KU Health System Department of Orthopedics and Sports Medicine (KUOrtho)meeting all requirements for TKA surgery.
  • •TKA surgical date scheduled ≥3 mos. from consent
  • •Own a Bluetooth enabled computer, tablet, or smart phone with the ability to join remote telehealth sessions and sync study self-monitoring devices.

排除标准

  • •Weight loss ≥10 pounds in previous 6 months
  • •Dairy/milk protein allergy
  • •Currently pregnant/breastfeeding or planning to become pregnant during the study
  • •Currently being treated for an eating disorder or history of an eating disorder diagnosis
  • •Pacemaker
  • •Current Cancer
  • •Diabetes Type 1 (insulin dependent)
  • •Hyperuricemia (untreated)
  • •Inflammatory bowel disease (active)
  • •Liver disease requiring protein restriction
  • •Myocardial infarction within last 3 months
  • •Abnormal ECG
  • •Renal insufficiency.

研究组 & 干预措施

Standard Care Control

No Intervention

Standard care

Intervention

Experimental

Multi-component weight loss intervention

干预措施: Multi-Component Weight Loss Intervention (Behavioral)

结局指标

主要结局

Participant Retention Feasibility

时间窗: 6 Months

Feasibility will be based on retention of ≥ 80% participants (i.e., \<20% participant dropout).

Participant Attendance Feasibility

时间窗: 6 Months

Feasibility will be based on ≥ 80% attendance at behavioral counseling sessions.

次要结局

  • Self reported knee function(6 Months)
  • Knee and Lower Extremity Physical Function (OARSI Test)(6 Months)
  • Fat Mass (kg)(6 Months)
  • Fat Free Mass (kg)(6 Months)
  • Body Weight (kg)(6 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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