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临床试验 NCT03954678 针对围手术期并发症目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情,或在此提出任何问题。
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Exercise in Patients Undergoing Urologic Surgery

招募中
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临床试验NCT03954678是一项针对围手术期并发症干预性研究试验,目前试验状态为招募中。试验始于2019年7月30日,计划招募400名患者。该研究由埃默里大学主导,预计于2026年7月1日完成。试验数据来源于ClinicalTrials.gov,最后更新时间为2025年7月22日
简要概括
Patients who are being scheduled for an operative procedure with an inpatient postoperative stay are eligible for this study. Participants will be selected to start a physical fitness plan or a nutrition plan at the time of surgical scheduling. Each participant will be asked to continue their current lifestyle for two days after their pre-operative appointment to get a baseline of activity (by pedometer and functional tests) and nutritional risk (by questionnaire). After two days, patients in the activity group will start their activity plans. They will be encouraged to get 10,000 steps per day and to perform whole body strength training exercises 3 times a week. Five days before and after surgery, participants in the nutrition group will be asked to consume a standard liquid nutrition supplement (i.e. Boost or Ensure) two times per day. Participants in the activity group will record steps and number of strength training sessions completed, while patients in the nutrition group will record the number of supplements consumed.
详细描述
Increases in physical activity and nutritional status are associated with improvements in a number of health conditions, including coronary artery disease, hypertension, stroke, insulin sensitivity, osteoporosis, and depression. Regretfully, despite the evidence supporting the benefits of physical activity, greater than half of adults in the United States do not get adequate activity and approximately one quarter do not get any activity. As such, many people, especially the elderly and those with comorbid diseases, have low levels of physical fitness. Additionally, up to 45% of community dwelling older adults are malnourished. Patients undergoing surgery with poor exercise tolerance and suboptimal nutritional status may be at an increased risk of perioperative complications. Thus, increasing physical activity and dietary intake quality prior to surgery is recommended, to hopefully decrease these risks. The primary objective is to determine if recommended physical activity or dietary intake results in an increase in patient physical function performance and if so, to what extent. The secondary goal is to examine if increased exercise or nutrition reduces perioperative complications.
官方标题

Prospective Randomized Study of Exercise in Patients Undergoing Urologic Surgery

疾病
围手术期并发症
其他研究标识符
  • IRB00044694
NCT编号
实际开始日期
2019-07-30
最近更新发布
2025-07-22
预计完成日期
2026-07
计划入组人数
400
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
Exercise
Nutrition supplement
Surgery
主要目的
预防
分配方式
随机
干预模型
平行
盲法
无(开放性试验)
试验组/干预措施
参与者组/试验组干预措施/治疗方法
实验性Exercise Group
Participants randomized to the activity intervention will aim for taking 10,000 steps per day and completing strength training exercises three times per week.
运动组
For the first two days after their pre-operative visit, participants will be asked to continue their present level of exercise and activity, which will be monitored by pedometer. Participants will begin the activity intervention on study Day 3. Participants will be instructed to take 10,000 steps per day, recording their daily steps with a pedometer. Participants also will be provided with resistance bands and instructed on how to safely perform 10 whole-body strength training exercises. They will be instructed to perform the exercises once per day, three days a week. Participants will complete the exercise intervention until they have surgery, which is typically 12 to 48 days after the pre-operative visit.
阳性对照Nutrition Group
Participants randomized to the nutrition intervention will consume a liquid over-the-counter nutrition supplement two times per day.
Nutrition Group
Participants in the nutrition group will be provided with a liquid over-the-counter nutrition supplement (i.e. Boost or Ensure) to consume. Participants will be instructed to consume 1 bottle, 2 times per day, beginning 5 days before surgery and continuing 5 days post-operatively.
主要终点
结果指标度量标准描述时间框架
Change in Body Mass Index (BMI)
Body Mass Index is a weight-to-height ratio, calculated by dividing one's weight in kilograms by the square of one's height in meters (kg/m\^2) and used as an indicator of underweight, normal, overweight and obese weights.
Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)
Change in Standing Task Time
Participants will be timed, in seconds, to see how quickly they can stand up and sit down in a chair 5 times.
Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)
Change in 6 Minute Walk Test (6MWT) Distance
The 6 minute walk test (6MWT) assesses distance, in meters, walked over 6 minutes as a sub-maximal test of aerobic capacity and endurance.
Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)
Change in grip strength
Hand grip is measured in pounds using a dynamometer to test the maximum isometric strength of the hand and forearm muscles. Grip strength is a measurement of muscle strength and tends to decline with frail states.
Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)
Change in Timed Up and Go (TUG) Task
Participants will be timed, in seconds, to see how quickly they can rise from a chair, walk 3 meters, turn around, walk back, and sit down.
Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)
Change in Short-Length Food Frequency Questionnaire
Nutritional risk will be assessed with the Short-Length Food Frequency Questionnaire. This 18-item instrument asks participants how frequently they consume certain foods, such as alcohol, produce, grains, and fried foods. There is not a summary score for this questionnaire, rather, the researchers can examine changes over time in foods consumed in a variety of ways.
Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)
次要终点
结果指标度量标准描述时间框架
Perioperative Complications
The number of perioperative complications will be compared between study arms.
30 days after surgery
资格标准

适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
  • Patients scheduled for operative procedure with an inpatient postoperative stay are eligible for this study
  • Patients willing and able to give blood sample as part of standard of care labs
  • Patients willing and able to fill out questionnaire
  • Patients who will fill out the step log daily
  • Patients willing and able to sign informed consent

  • None
研究责任方
Kenneth Ogan, 主要研究者, Professor, Emory University
研究中心联系人
联系人: Kenneth Ogan, MD, (404) 778-4898, [email protected]
1 位于 1 个国家/地区的研究中心

Georgia

Emory University Hospital, Atlanta, Georgia, 30322, United States
招募中