Effect of Non-invasive Auricular Vagal Nerve Stimulation Versus Circuit Weight Training on Nutritional Modulation in Patient With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Cortisol level
研究概览
简要总结
Participants were randomly assigned to two groups prior to their second visit: the Vagus nerve stimulation group (VNS) and the circuit training program. The randomization processes were conducted in Excel utilizing a random-number generator. Prior to the second visit, each participants' target exercise heart rate ranges were determined. Vagus nerve stimulation group(VNS) Patients rested on their sides in a sitting position. Following regular disinfection of the stimulation locations, ear clips were placed in the ear region (auricular concha) at the stimulation site. The training regimen included ten different forms of resistance and aerobic exercises.
详细描述
Vagus nerve stimulation group Group:
- Each participant signed a consent form after receiving a detailed explanation about the procedure.
- Patients rested on their sides in a sitting position.
- Disinfection of the stimulation locations.
- Ear clips were placed in the ear region (auricular concha) at the stimulation site.
- Emotional eating was assessed by Emotional Eating Scale. 5. Patient satisfaction was assessed by The Short Assessment of Patient Satisfaction (SAPS).
- Cortisol was assessed in lab. 7. After one month all the assessment procedure will be repeated again.
Circuit training group Group:
- Each participant will signed a consent form after receiving a detailed explanation about the procedure.
- The training regimen included ten different forms of resistance and aerobic exercises.
- Emotional eating was assessed by Emotional Eating Scale.
- Patient satisfaction was assessed by The Short Assessment of Patient Satisfaction (SAPS).
5 Cortisol was assessed in lab. 6. After one month all the assessment procedure will be repeated again.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •having two or more than one of the following:
- •Type 2 diabetes Miletus
- •Hypertensive.
- •Abnormal Cholesterol or Triglyceride level.
- •BMI more than 30 kg/m
- •Waist circumference more than 94 cm.
排除标准
- •Vagotomy.
- •Diathermy.
- •Wallowing difficulties.
- •Cardiac arrhythmia.
- •Previous brain injury or surgery.
- •Dysautonomia.
研究组 & 干预措施
Vagus nerve stimulation group
Vagus nerve stimulation group
干预措施: Vagal Stimulation (Device)
Vagus nerve stimulation group
Vagus nerve stimulation group
干预措施: Circuit training program (Other)
Circuit weight training group Group
Circuit weight training group Group
干预措施: Circuit training program (Other)
结局指标
主要结局
Cortisol level
时间窗: 4 weeks
Participants use a disposable plastic straw to 'drool' saliva into the tube after collecting it in their mouths for a predetermined period of time (one minute) Saliva samples for cortisol measurement kept at room temperature until they are examined in a lab (4 to 6 hours)
Emotional eating
时间窗: 4 weeks
Emotional Eating was measured by a 15-item version of the Emotional Eating Scale. The scale required responses from 0 (no desire to eat) to 4 (an overwhelming urge to eat) based on "… the extent which the following feelings presently lead you to feel an urge to eat. A lower score indicated less of an urge to eat when the designated emotional state was present.
Patient satisfaction measures
时间窗: 4 weeks
The Short Assessment of Patient Satisfaction (SAPS) is a seven-item scale that can be utilized to measure patient satisfaction with their treatment. The seven-item Short Assessment of Patient Satisfaction (SAPS), which is scored on a 5-point scale (0-4) SAPS has a continuous score range of 0 to 28. SAPS categorical responses include 0-10 very dissatisfied, 11-18 dissatisfied, 19-26 satisfied, and 27-28 very satisfied.
次要结局
- Body weight(4 weeks)
研究者
Rana Elbanna
lecturer at faculty of physical therapy at Cairo University
Cairo University